title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Main outcome | REGRESSION | To assess the effect of actual exposure to the POINCARE-2 strategy on vital status at Day60, two different analyses were carried out: (1) a “naive” logistic regression model adjusted for potential confounders (model 1); and (2) a logistic regression model with the addition of an instrumental variable using the two-stag... | PMC10626740 | |
Subgroup analyses | REGRESSION, ACUTE RESPIRATORY DISTRESS SYNDROME, SEPTIC SHOCK | We added an interaction term to the naive logistic regression model (model 1) to test for a possible subgroup effect of the POINCARE-2 strategy according to the main cause of admission (septic shock, Acute Respiratory Distress Syndrome (ADRS), Central Nervous System (CNS) injury, or other). | PMC10626740 | |
Sensitivity analyses | We conducted sensitivity analyses for the main outcome in the subsample of complete cases. | PMC10626740 | ||
Secondary outcomes | renal damage, RIFLE, VFDs | REGRESSION, EVENT, END STAGE RENAL DISEASE, SECONDARY | We used zero-inflated negative binomial (or zero-inflated Poisson) mixed models to assess the effect of exposure to the POINCARE-2 strategy on the cumulative number of MVFDs and VFDs. Logistic regression models adjusted for potential confounders were computed to examine the effect of the strategy on the occurrence of a... | PMC10626740 |
Ethics | Because the POINCARE-2 strategy focused on health care organization, written informed consent was waived in accordance with French law (Bill number 2012–300 on March 5, 2012 about research involving humans). | PMC10626740 | ||
Results | PMC10626740 | |||
Patients’ characteristics at admission | critically ill | CRITICALLY ILL | A total of 1361 patients were included in the present study, i.e. 718 in the control group and 643 in the strategy group (Fig. Flowchart of critically ill patients recruited and followed up in the POINCARE-2 trial | PMC10626740 |
Exposure to the POINCARE-2 strategy | Mean (SD) score of exposure to the strategy was 80.5 (19.3) in the strategy group vs. 55.2 (24.6) in the control group (overall, 67.1 (25.6)). Overall, 446 (69.4%) patients in the strategy group vs. 178 patients (24.8%) in the control group, had a score of exposure to the strategy ≥ 75 and were further considered as ex... | PMC10626740 | ||
Mortality and safety during follow-up | myocardial infarction | HYPERNATREMIA, SECONDARY, MYOCARDIAL INFARCTION | Vital status at Day 60 and safety outcomes are described in Table Occurrence of primary and secondary outcomes(#) RRT: Renal-replacement therapyForty-five (3.3%) patients presented at least one episode of hypernatremia > 155 mmol/L, and 14 (1.0%) had an episode of mesenteric or myocardial infarction during follow-up. | PMC10626740 |
Effect of the exposure to the POINCARE-2 strategy on 60-day mortality | PMC10626740 | |||
Results from instrumental variable analysis | Exposure to the POINCARE-2 strategy was not associated with 60-day mortality both in the MI dataset (OR | PMC10626740 | ||
Results according to cause of admission: subgroup analyses | ACUTE RESPIRATORY DISTRESS SYNDROME | Results of the subgroup analyses are presented in Table Effect of the exposure to the POINCARE-2 strategy on vital status at Day60 according to the main cause of admission*ARDS: Acute respiratory distress syndrome ~ CNS: Central nervous system | PMC10626740 | |
Effect of exposure to the POINCARE-2 strategy on secondary outcomes | SECONDARY | Results for secondary outcomes are presented in Additional file | PMC10626740 | |
MVFDs | After adjustment for potential confounders, we found a negative association between exposure to the strategy and MVFDs, both on the imputed and on the complete case datasets (Additional file | PMC10626740 | ||
VFDs | VFDs | We found no significant association of the exposure to the POINCARE-2 strategy with the cumulative number of VFDs between Day0 and Day28 (Additional file | PMC10626740 | |
Unexpected harmful events | hypernatremia, hypokalemia, hypotension | HYPERNATREMIA, EVENT, EVENTS | We found no significant association between exposure to the POINCARE-2 strategy and occurrence of at least one unexpected harmful event (i.e., arterial hypotension between Day2 and Day14, hypernatremia between Day2 and Day14, hypokalemia between Day2 and Day14, and acute ischemic events between Day3 and discharge) (Add... | PMC10626740 |
Renal damage | RIFLE | We found no significant association between exposure to the POINCARE-2 strategy and worsening in the RIFLE criteria between Day3 and Day14 (Additional file | PMC10626740 | |
Discussion | critically ill | CRITICALLY ILL, FLUID OVERLOAD | Similarly to the intention-to-treat analyses [These results are in line with previous findings. While the deleterious effect of fluid overload on mortality has been repeatedly reported in observational studies in critically ill patients [The highest evidence derived from randomized controlled trials (RCT) comes from in... | PMC10626740 |
Conclusions | critically ill | CRITICALLY ILL | As-treated analyses did not show a significant effect of the POINCARE-2 fluid balance control strategy on mortality in a broad population of critically ill patients. Further research, such as target trial emulation or a complete process evaluation, might help understand the conditions required for conservative strategi... | PMC10626740 |
Acknowledgements | Gilles | Data safety management board: Jean-François Timsit, MD PhD, Hôpital Bichat, Paris, Yves Le Tulzo, MD PhD, CHU de Rennes, Gilles Hilbert, MD PhD, CHU de Bordeaux. | PMC10626740 | |
Author contributions | POINCARE-2 trial was designed jointly by NA and PEB. CHRU Nancy, Inserm, Université de Lorraine, CIC, Epidémiologie Clinique was in charge of data collection, management, analyses, and interpretation in collaboration with the authors. Randomization and data management were supervised by JMV, and statistical analyses co... | PMC10626740 | ||
Funding | POINCARE-2 trial was supported by a grant from the French Ministry of Health, | PMC10626740 | ||
Availability of data and materials | Due to restrictions pertaining to French laws, the datasets generated and/or analyzed during POINCARE-2 trial are not publicly available. However, data transfer agreement remains possible and data can be made available upon reasonable request to the corresponding author. | PMC10626740 | ||
Declarations | PMC10626740 | |||
Ethics approval and consent to participate | The Comité de Protection des Personnes Est III, Grand-Est, North-East France, has reviewed and approved POINCARE-2 trial (ID-RCB: 2015-A00662-47).Patients and their kin were informed about the trial protocol and their right to refuse to participate. Written informed consent was waived in accordance with the French law ... | PMC10626740 | ||
Consent for publication | Not applicable. | PMC10626740 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10626740 | ||
References | PMC10626740 | |||
Key Points | PMC10448373 | |||
Question | microvascular disease | How does coronary venous pressure influence myocardial resistances in patients with microvascular disease? | PMC10448373 | |
Findings | microvascular disease | In this blinded, physiology end point, sham-controlled randomized clinical trial that included 20 adults with microvascular disease, an increase in coronary venous pressure led to significantly decreased resting and hyperemic microvascular resistances. | PMC10448373 | |
Meaning | MICROVASCULAR ANGINA | In patients with microvascular angina, the coronary venous circulation may be a novel therapy target. | PMC10448373 | |
Importance | microvascular angina | MICROVASCULAR ANGINA | The role of the coronary venous circulation in regulating myocardial perfusion and its potential in treating microvascular angina is unexplored. | PMC10448373 |
Objective | MICROVASCULAR ANGINA | To evaluate whether an increase in coronary venous pressure modifies microvascular resistance in patients with microvascular angina. | PMC10448373 | |
Design, Setting, and Participants | epicardial coronary disease, microvascular dysfunction, pulmonary or kidney disease, angina pectoris | ATRIOVENTRICULAR BLOCK, VALVULAR HEART DISEASE, CARDIOMYOPATHY | This was a blinded, sham-controlled, crossover, randomized clinical trial that enrolled participants between November 2021 and January 2023. Participants for this physiology end point study were recruited from the Cardiology Center of the University of Medicine in Mainz, Germany. Patients with moderate/severe angina pe... | PMC10448373 |
Intervention | cardiac coronary sinus | Inflation of an undersized balloon placed in the cardiac coronary sinus (CS), hereafter referred to as | PMC10448373 | |
Main Outcomes and Measures | Hemodynamic parameters, including aortic (Pa) and distal (Pd) coronary pressure, coronary sinus pressure (Pcs), right atrial pressure (Pra), and the mean transit time (inverse of blood flow [Tmn]), were measured. | PMC10448373 | ||
Results | hyperemia, diabetes | HYPERTENSION, HYPERCHOLESTEROLEMIA, HYPEREMIA, DIABETES | A total of 20 patients (median [IQR] age, 69 [64-75] years; 11 female [55.0%]) were included in the study. Two patients (10%) had diabetes, 6 (30%) had hypercholesterolemia, 15 (75%) had hypertension, and 3 (15%) were active smokers. The inflation of the CS balloon caused a significant increase in CS pressure at rest a... | PMC10448373 |
Conclusion and Relevance | reduction of microvascular resistances | DISEASE, MICROVASCULAR ANGINA | Increased coronary venous pressure led to a reduction of microvascular resistances in patients with microvascular angina, a mechanism with potential implications for the therapy of this complex disease. | PMC10448373 |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10448373 | ||
Introduction | microvascular dysfunction, Microvascular angina pectoris | Microvascular angina pectoris (MVA) is a complex clinical condition in which functional and/or structural changes in the coronary microcirculation determine an increase in vascular tone compromising myocardial perfusion.Empirical observations suggest that implantation of a coronary sinus reducer may improve myocardial ... | PMC10448373 | |
Methods | PMC10448373 | |||
Study Design | This study was a sham-controlled, crossover, randomized clinical trial to investigate the effect of changes in coronary venous pressure on microvascular resistances. The protocol (described in detail elsewhere; | PMC10448373 | ||
Study Population | epicardial stenosis, chronic angina, ischemia, pulmonary or kidney disease, microvascular dysfunction | ATRIOVENTRICULAR BLOCK, ISCHEMIA, VALVULAR HEART DISEASE, CARDIOMYOPATHY | Patients had chronic angina (Canadian Cardiovascular Society 2-4) without epicardial stenosis, reversible ischemia on noninvasive testing, and evidence of microvascular dysfunction (index of microvascular resistance [IMR] ≥25 mm Hg × s). Main exclusion criteria were second- or third-degree atrioventricular block, any v... | PMC10448373 |
Procedures | PMC10448373 | |||
Randomization and Intervention | hyperemia | HYPEREMIA | Vasoactive therapies were suspended for more than 12 hours before measurements were taken. Patients were randomly assigned 1:1 to 1 of 2 arms (sham/balloon or balloon/sham), with each patient undergoing invasive measurements at rest and during hyperemia in both conditions ( | PMC10448373 |
Study Protocol | microvascular angina | MICROVASCULAR ANGINA | A total of 20 patients with microvascular angina were randomly assigned to treatment in this crossover, sham-controlled trial to assess the effect of inflation of a coronary sinus balloon on myocardial hemodynamic. IMR indicates index of microvascular resistance. | PMC10448373 |
Hemodynamic Measurements | myocardial ischemia | MYOCARDIAL ISCHEMIA | Coronary microvascular function assessments were performed with a wire-based thermodilution method using Pressure Wire X (Abbott Vascular) as per instructions for use; the same hyperemic agent was used for the 2 sets of measurements in each patient (sham and balloon). The mean transit time (Tmn), coronary flow reserve ... | PMC10448373 |
Trial End Points | The study’s primary end point was the (hyperemic) IMR during the inflation of the CS balloon as compared with sham. IMR was calculated as [( | PMC10448373 | ||
Statistical Analysis | Randomization was performed by a computer-generated random sequence with permuted blocks. The power calculation was based on previous articles investigating the effect of acute administration of fasudil and enalaprilat on IMR.The primary analysis was performed as a within-participant comparison of the primary parameter... | PMC10448373 | ||
Results | A total of 20 patients (median [IQR] age, 69 [64-75] years; 11 female [55.0%]; 9 male [45%]) were enrolled in this physiology end point study (eTable in Hemodynamic data are presented in the | PMC10448373 | ||
Hemodynamic Variables and Effects of Balloon Inflation at Rest and During Hyperemia | Abbreviations: CFR, coronary flow reserve; FFR, fractional flow reserve; IMR, index of microvascular resistance; MRR, microvascular resistance reserve; Pa, mean aortic pressure; Pcs, mean pressure in the coronary sinus; Pd, mean distal coronary pressure; Pra, mean pressure in the right atrium; Tmn, mean transit time.Th... | PMC10448373 | ||
The Primary End Point of the Trial | Balloon inflation caused a decrease in resting and hyperemic microvascular resistances. IMR indicates index of microvascular resistance. | PMC10448373 | ||
Discussion | microvascular disease, hyperemia, angina | HYPEREMIA | Many patients undergoing diagnostic coronary angiography for angina have microvascular disease.Animal models in the peripheral circulation show that total vascular resistance within the coronary circulation is determined by vascular resistance and viscosity, with the latter playing a multiplicative role during hyperemi... | PMC10448373 |
Limitations | microvascular dysfunction | DISEASE | This study has some limitations. Of note, a mechanistic study is not designed or powered to assess clinical benefit, and we only studied the effect of a single acute increase in CS pressure in patients with microvascular dysfunction. Whether similar effects occur over chronic periods and in patients with epicardial (as... | PMC10448373 |
Conclusions | In this crossover randomized clinical trial, the current findings that an acute increase in CS pressure led to a decrease in microvascular resistance and an increase in blood flow allow hypothesizing that the venous vasculature may be leveraged to improve coronary resistances in patients with MVA. This may have implica... | PMC10448373 | ||
Objective | stroke | STROKE | Investigate feasibility and acceptability of prism adaptation training for
people with inattention (spatial neglect), early after stroke, during usual
care. | PMC9912302 |
Design | Phase II feasibility randomised controlled trial with 3:1 stratified
allocation to standard occupational therapy with or without intervention,
and nested process evaluation. | PMC9912302 | ||
Setting | stroke | STROKE | Ten hospital sites providing in-patient stroke services. | PMC9912302 |
Participants | post-stroke | Screened positive for inattention more than one-week post-stroke; informal
carers. Occupational therapists participated in qualitative interviews. | PMC9912302 | |
Intervention | Adjunctive prism adaptation training at the start of standard occupational
therapy sessions for three weeks. | PMC9912302 | ||
Main measures | RECRUITMENT | Feasibility measures included recruitment and retention rates, intervention
fidelity and attrition. Outcomes collected at baseline, 3 weeks and 12 weeks
tested measures including Nottingham Extended Activities of Daily Living
Scale. Acceptability was explored through qualitative interviews and
structured questions. | PMC9912302 | |
Results | ADVERSE EVENTS | Eighty (31%) patients were eligible, 57 (71%) consented, 54 randomised
(40:13, +1 exclusion) and 39 (74%) completed 12-week outcomes. Treatment
fidelity was good: participants received median eight intervention sessions
(IQR: 5, 12) lasting 4.7 min (IQR: 4.1, 5.0). All six serious adverse events
were unrelated. There w... | PMC9912302 | |
Conclusions | stroke | STROKE | It is feasible and acceptable to conduct a high-quality definitive trial of
prism adaptation training within occupational therapy early after stroke in
usual care setting, but difficult to justify given no sign of benefit over
standard occupational therapy. | PMC9912302 |
Introduction | stroke, cognitive syndrome | STROKE, RECRUITMENT | There is no robust evidence that any therapy reduces the disabling effects of spatial
inattention (also known as spatial neglect), a cognitive syndrome affecting
awareness towards one side of the body or environment.Prism adaptation training is purported to show short-term relief of spatial deficits
but clinical effect... | PMC9912302 |
Methods | TIA, stroke, post-stroke, Stroke | TRANSIENT ISCHAEMIC ATTACK, STROKE, STROKE, RECRUITMENT, SECONDARY, REGRESSION, EVENTS, TIA | This was a pragmatic, feasibility Phase II multi-centre stratified randomised
controlled trial with nested process evaluation, designed with collaborative level
patient involvement. The study was approved by the Yorkshire and the Humber NHS
Research Ethics Committee (18/YH/048) and entered on the ISRCTN registry, We mo... | PMC9912302 |
Discussion | stroke, strokes, post-stroke, Fatigue | STROKE, STROKES, RECRUITMENT, ATTRITION | We demonstrated that it would be feasible and acceptable to conduct a definitive
trial of a rehabilitation intervention for stroke survivors with inattention,
delivered by NHS occupational therapists, beginning very early after stroke in the
inpatient usual care rehabilitation setting. We established realistic estimate... | PMC9912302 |
Clinical messages | stroke, post-stroke inattention, post-stroke | STROKE | Patients with post-stroke inattention, carers and therapists are willing
and able to participate in research early post-stroke in a hospital
setting.Although brief prism adaptation training was acceptable to deliver at the
start of occupational therapy sessions, we did not detect any benefit
over and above occupational... | PMC9912302 |
Supplemental Material | PMC9912302 | |||
sj-doc-1-cre-10.1177_02692155221134060 - Supplemental material for A
study of prisms and therapy in attention loss after stroke (SPATIAL): A
feasibility randomised controlled trial | stroke, attention loss | STROKE | Click here for additional data file.Supplemental material, sj-doc-1-cre-10.1177_02692155221134060 for A study of
prisms and therapy in attention loss after stroke (SPATIAL): A feasibility
randomised controlled trial by Verity Longley, Kate Woodward-Nutt, Ailie J.
Turton, Katie Stocking, Matthew Checketts, Ann Bamford, ... | PMC9912302 |
sj-docx-2-cre-10.1177_02692155221134060 - Supplemental material for A
study of prisms and therapy in attention loss after stroke (SPATIAL): A
feasibility randomised controlled trial | stroke, attention loss | STROKE | Click here for additional data file.Supplemental material, sj-docx-2-cre-10.1177_02692155221134060 for A study of
prisms and therapy in attention loss after stroke (SPATIAL): A feasibility
randomised controlled trial by Verity Longley, Kate Woodward-Nutt, Ailie J.
Turton, Katie Stocking, Matthew Checketts, Ann Bamford,... | PMC9912302 |
sj-docx-3-cre-10.1177_02692155221134060 - Supplemental material for A
study of prisms and therapy in attention loss after stroke (SPATIAL): A
feasibility randomised controlled trial | stroke, attention loss | STROKE | Click here for additional data file.Supplemental material, sj-docx-3-cre-10.1177_02692155221134060 for A study of
prisms and therapy in attention loss after stroke (SPATIAL): A feasibility
randomised controlled trial by Verity Longley, Kate Woodward-Nutt, Ailie J.
Turton, Katie Stocking, Matthew Checketts, Ann Bamford,... | PMC9912302 |
sj-docx-4-cre-10.1177_02692155221134060 - Supplemental material for A
study of prisms and therapy in attention loss after stroke (SPATIAL): A
feasibility randomised controlled trial | stroke, attention loss | STROKE | Click here for additional data file.Supplemental material, sj-docx-4-cre-10.1177_02692155221134060 for A study of
prisms and therapy in attention loss after stroke (SPATIAL): A feasibility
randomised controlled trial by Verity Longley, Kate Woodward-Nutt, Ailie J.
Turton, Katie Stocking, Matthew Checketts, Ann Bamford,... | PMC9912302 |
References | PMC9912302 | |||
1. Introduction | fracture, fractures | ADVERSE EVENTS, SECONDARY, RECRUITMENT | Although hip fractures are common and severe, there is insufficient evidence concerning which type of rehabilitation is most beneficial. The primary aim of this three-armed pilot study was to investigate any difference in outcome after hip fractures between and within groups in terms of balance, everyday activities, an... | PMC9967499 |
2. Materials and Methods | PMC9967499 | |||
2.1. Study Design | A three-armed pilot study was designed. Two intervention groups were included, namely, (1) participants following the HIFE program and (2) participants following the HIFE program, with the addition of data collection using a wearable device measuring body position and movement, and (3) a control group. The design of th... | PMC9967499 | ||
2.2. Study Setting | fracture | The study was performed in Malmö, the third largest city in Sweden, with approximately 330,000 inhabitants. Every year, about 700 individuals are admitted and treated for a hip fracture at Skåne University Hospital in Malmö [ | PMC9967499 | |
2.3. Recruitment and Participant Inclusion/Exclusion | fracture, major neurological diseases, cognitive impairment, cognitive disease | The inclusion criteria were being hospitalized, treated for a hip fracture, and in need of home-based rehabilitation. The exclusion criteria were (1) not being able to read and understand Swedish, (2) having major neurological diseases impacting walking and balance, and (3) having a diagnosed cognitive disease or sever... | PMC9967499 | |
2.4. Randomization | A cluster randomization procedure was applied, a 6-based cluster, thus giving each cluster 2 participants to each intervention arm. Sealed envelopes were used. The numbers were randomly drawn by a person that had no contact with the participants or the researcher. | PMC9967499 | ||
2.5. Intervention | PROGRESSION | All participants received an individually tailored intervention in either one of the intervention groups (HIFE) or the control group (standard rehabilitation). In all three groups, home visits by the physiotherapist were included. At these home visits, exercises were added or adjusted when needed.Intervention group 1: ... | PMC9967499 | |
2.6. Outcomes | Feasibility was the main outcome measure and measured by means of Patient-related outcomes were balance-measured as postural sway, functional balance, functional independence in everyday activities, and health-related quality of life (HRQoL). Measures of postural sway, especially in the medio-lateral direction, have be... | PMC9967499 | ||
2.7. Measurement | An IMU measures linear acceleration and rotation. The study used 2 different types of IMUs, one for intermittent measurements of postural sway and one for continuous measurements of body positions and movement. The IMU that measured postural sway was used in all 3 groups to measure postural sway in the anterior/posteri... | PMC9967499 | ||
2.8. Procedure | fracture | SECONDARY | Before the data collection, all health care personnel involved in hip fracture rehabilitation in Malmö municipality were trained in the HIFE program and in using the IMU device. Several workshops were held with the participation of leaders from the rehabilitation unit and technicians who developed the IMU device. After... | PMC9967499 |
2.9. Statistical Methods | SECONDARY | A previous study was used to calculate statistical power [The data were not normally distributed, and due to the small sample sizes, the difference in the primary and secondary outcomes between the 3 groups was analyzed using the Kruskal–Wallis test. To measure within-group differences, the Mann–Whitney U test was used... | PMC9967499 | |
3. Results | intramedullary nail fixation, fracture, Pain | A total of 32 participants were included in the study, 25 women and 7 men aged between 56 and 95 years of age (Md 85 years), during the period of January 2021 to June 2022. A total of 10 persons had had a hip arthroplasty, 19 had had intramedullary nail fixation, and 3 had had other surgical treatments. A total of 22 p... | PMC9967499 | |
3.1. Feasibility Measures | RECRUITMENT | In total, there were 61 qualified participants for the feasibility study. The recruitment rate was 52%, and the retention rate 78% at the primary follow-up assessments. Seven participants dropped out of the study. The reasons for drop out were unknown reasons ( | PMC9967499 | |
3.2. Adverse Events | EVENTS, DYSFUNCTION | No harmful events occurred during the trial period. However, five events were observed during the data collection that negatively influenced the study procedure, namely, problems with the IMU device, such as not being used, having a low battery, or dysfunction. | PMC9967499 | |
3.3. Within-Group Differences | All three groups improved in functional balance (FBG) (intervention group 1 | PMC9967499 | ||
3.4. Between-Group Differences | There were no differences in changes between baseline and follow-up for any measure ( | PMC9967499 | ||
3.5. Adjustments before the Full RCT | RECRUITMENT | Based on the results from this pilot and feasibility study and from the information obtained at the final workshop with the participating physiotherapists, a number of adjustments are necessary before continuing to a full RCT. To improve the recruitment rate, physiotherapists and occupational therapists at the orthoped... | PMC9967499 | |
4. Discussion | cognitive impairments, fracture, fractures, loss of mobility and high age | EVENTS, SECONDARY, RECRUITMENT | This pilot study shows that the recruitment rate was considered high, while the collection of primary data was considered high, except for postural sway, which was considered low. The collection of secondary outcomes was considered low. No harmful events were reported. The study also shows that there was no gain in ter... | PMC9967499 |
Strengths and Limitations | Firstly, there were some problems when collecting data on postural sway with the IMU device. The device did not show when it was fully charged, and, therefore, it sometimes turned out to be uncharged at the time of data collection. Moreover, the instructions for standardizing the measuring procedure were not clear enou... | PMC9967499 | ||
5. Conclusions | fracture | The results of this pilot and feasibility study show that a full RCT is feasible and can be conducted after adjustments to the protocol. The adjustments include changing to a two-armed RCT, adding two measurements and excluding one, and modifying the instructions and handling of the IMU when measuring postural sway. Th... | PMC9967499 | |
Author Contributions | Conceptualization, E.E.H., A.M.F. and C.R.; methodology, E.E.H., A.M.F. and C.R.; formal analysis, D.F.H.; data curation, D.F.H.; writing—original draft preparation, D.F.H.; writing—review and editing, D.F.H., E.E.H., A.M.F. and C.R.; supervision, E.E.H.; project administration, E.E.H. All authors have read and agreed ... | PMC9967499 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Swedish Ethical Review Authority (2020-00789, approved 10 June 2020). | PMC9967499 | ||
Informed Consent Statement | Informed consent was obtained from all study participants. Participation was voluntary and did not affect the rehabilitation or other health care treatments. The participants could withdraw at any point and did not have to provide a reason for it. | PMC9967499 | ||
Data Availability Statement | The data used in this study contain sensitive information about the study participants, and they did not provide consent for public data sharing. The current approval by the Swedish Ethical Review Authority does not include data sharing. A minimal data set could be shared on request from a qualified academic investigat... | PMC9967499 | ||
Conflicts of Interest | The authors declare no conflict of interest, and no external funding was received for the study. | PMC9967499 | ||
References | The inertial measurement unit used in intervention group 2.Flow chart of the study. Reasons for drop out were not known (Categories and examples of HIFE exercises.Intensity scales for HIFE exercises.* Exercise performed close to the limit of postural stability.Median and interquartile range (IQR) for baseline measures ... | PMC9967499 |
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