The GET FIT trial (NCT01635413): A randomized controlled trial of strength training versus Tai Ji Quan for fall prevention among female cancer survivors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12059-12059
Author(s):  
Kerri M. Winters-Stone ◽  
Fuzhong Li ◽  
Fay B. Horak ◽  
Sydnee Stoyles ◽  
Nathan Dieckmann ◽  
...  
Keyword(s):  
Postural Control ◽  
Cancer Survivors ◽  
Strength Training ◽  
Fall Prevention ◽  
Controlled Trial ◽  
Control Group ◽  
Placebo Control ◽  
Leg Strength ◽  
Tai Ji

12059 Background: Women with cancer are significantly more likely to fall than women without cancer but there are not yet any evidence-based fall prevention strategies that specifically target cancer survivors. The GET FIT trial compares the efficacy of two distinct types of exercise, strength training vs. tai ji quan, to prevent falls in women finished with chemotherapy. Methods: We conducted a 3 group, single-blind, parallel design, randomized controlled trial in older, inactive women cancer survivors treated with chemotherapy. Women were randomly assigned to 1 of 3 intervention groups: 1) strength training, 2) tai ji quan or 3) a placebo control group (stretching) that trained 2x/week for 6 months. Additional follow-up occurred 6 months after formal training stopped. The primary outcome was fall rate across 6-and 12 months; secondary outcomes, reflective of training fidelity, were maximal leg strength (by 1-repetition maximum) and dynamic postural control (by computerized dynamic posturography), collected at 0, 3, and 6 months. Results: 442 women (mean age 62.4 + 6.3 yrs.) were enrolled and randomly assigned to study groups. Over the 6 months prior to enrollment, 21% of the sample (n = 94) reported at least one fall (of which, 37% (n = 35) reported two or more falls)), and 12% (n = 51) reported at least one injurious fall. Retention across the 12 months study period was 88%, while adherence to the study interventions over 6 months averaged 73%, 71%, and 74% for the strength, tai ji quan and stretching (control) groups, respectively. 26% of the sample (n = 99 of 382) reported at least one fall during the intervention and 27% (n = 102) reported falls during follow up. Using regression models, there were no significant differences in the odds of having at least one fall during the intervention period (1-6 months) or across the entire follow-up period (1-12 months) between the control and either the strength or tai ji quan groups. At 6 months, the strength group showed a greater increase from baseline in maximal leg strength (+14.3 kg, 95% CI: 11.4-17.1) than the control group (+7.5 kg, 95% CI: 4.6-10.4, p = 0.002). Whereas, the tai ji quan group showed a greater increase in dynamic postural control (+2.42%, 95% CI: 1.36-3.48) compared to the control group (+0.35%, 95% CI: -0.69-1.38, p = 0.007). Conclusions: Despite evidence for fidelity of strength and tai ji quan training to improve muscle strength and postural control, respectively, neither program significantly lowered fall rates over a placebo control group. It is possible that the dose of exercise was too low and/or the sample was not at high risk of falls. The etiology of fall risk in women cancer survivors needs to be better understood as it may differ from risk factors in older adults. Future trials should consider patient-centered, tailored fall-prevention interventions for cancer survivors based on identified fall risk factors. Clinical trial information: NCT01635413.

scholarly journals A Randomized Placebo-Controlled Study on the Effectiveness of the “Three Good Things for Others” Intervention

2021 ◽  
Vol 12 ◽  
Author(s):  
Mariola Laguna ◽  
Michał Kȩdra ◽  
Zofia Mazur-Socha
Keyword(s):  
Negative Affect ◽  
Prosocial Behavior ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Placebo Control ◽  
General Tendency ◽  
Childhood Memories ◽  
Group A

The aim of our study was to test the effectiveness of the “three good things for others” intervention. We used the randomized controlled trial method, with four measurements (pretest, posttest, follow-up after 2 weeks, follow-up after 4 weeks) and with random assignment of participants to experimental and placebo control groups. We investigated the effects of the intervention on prosocial behavior, and in addition on positive and negative affect, and positive orientation (a general tendency to approach reality in a positive way). The results showed an increase in positive affect and a decrease in negative affect in the experimental group a day after the intervention. These effects, however, did not endure over the next 2 or 4 weeks. We also observed a statistically significant increase in prosocial behavior in the placebo control group, in which participants were engaged in a task of recalling childhood memories. The results are discussed and recommendations for future studies are proposed.

scholarly journals Protocol for GET FIT Prostate: a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kerri M. Winters-Stone ◽  
Fuzhong Li ◽  
Fay Horak ◽  
Nathan Dieckmann ◽  
Arthur Hung ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Survivors ◽  
Strength Training ◽  
Physical Functioning ◽  
Control Group ◽  
Relative Efficacy ◽  
Prostate Cancer Survivors ◽  
Group Randomized Trial ◽  
Tai Ji ◽  
Secondary Outcomes

Abstract Background Many prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer. Methods Prostate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: (i) strength training, (ii) tai ji quan training, or (iii) stretching (control), that train 3×/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention), and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed effects modeling will be used to compare the relative efficacy of training group on secondary outcomes. Discussion Exercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise, men may be able to avoid or delay falls, frailty, and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT. Trial registration ClinicalTrials.gov NCT03741335. Registered on November 18, 2018.

scholarly journals Protocol for GET FIT Prostate: A Randomized, Controlled Trial of Group Exercise Training for Fall Prevention and Functional Improvements During and After Treatment for Prostate Cancer

2021 ◽  
Author(s):  
Kerri Winters-Stone ◽  
Fuzhong Li ◽  
Fay Horak ◽  
Nathan Dieckmann ◽  
Arthur Hung ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Survivors ◽  
Strength Training ◽  
Physical Functioning ◽  
Control Group ◽  
Relative Efficacy ◽  
Prostate Cancer Survivors ◽  
Group Randomized Trial ◽  
Tai Ji ◽  
Secondary Outcomes

Abstract BackgroundMany prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty and physical functioning in men expose to ADT for prostate cancer.MethodsProstate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: i) strength training, ii) tai ji quan training, or iii) stretching (control), that train 3x/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention) and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: Frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); Objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed-effects modeling will be used to compare the relative efficacy of training group on secondary outcomes.DiscussionExercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise men may be able to avoid or delay falls, frailty and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT.Trial Registration: ClinicalTrials.gov NCT03741335. Registered November 18, 2018. https://clinicaltrials.gov/ct2/show/NCT03741335

scholarly journals Effect of a 12-Week Online Walking Intervention on Health and Quality of Life in Cancer Survivors: A Quasi-Randomized Controlled Trial

2018 ◽  
Vol 15 (10) ◽  
pp. 2081 ◽  
Author(s):  
Lauren Frensham ◽  
Gaynor Parfitt ◽  
James Dollman
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Cancer Survivors ◽  
Goal Setting ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Walking Intervention

Cancer survivors are at an increased risk of experiencing physical and psychological ill-effects following cancer treatment. Rural cancer survivors are at a greater risk of future health problems following a cancer diagnosis compared to their urban counterparts. Physical activity has been targeted as a health promotion priority in cancer survivors. Research indicates that a large portion of cancer survivors do not meet physical activity recommendations. The purpose of this quasi-randomized controlled trial was to test the effectiveness of an online 12-week walking intervention designed for cancer survivors, and to explore its impact on physical health indicators and quality of life outcomes. Steps Toward Improving Diet and Exercise among cancer survivors (STRIDE) is an online resource designed according to Social Cognitive Theory and Self Determination Theory, based on individualized step goal setting. Measures of physiology, physical fitness, and quality of life were taken at the baseline, post-intervention, and three-month follow-up in an Intervention group (n = 46) and active Control group (n = 45). The Control group was provided with a pedometer but did not have access to the online program. Three-factor repeated measures ANOVAs indicated that there were improvements in physical fitness (p < 0.01), systolic blood pressure (p < 0.01), diastolic blood pressure (p < 0.01), waist girth (p < 0.01), mental health (p < 0.05), social functioning (p < 0.01), and general health (p < 0.01), but an increase in bodily pain (p < 0.01), from the baseline to week 12 and the three-month follow-up, irrespective of group allocation. Pedometer interventions, delivered with or without online support and step goal setting, show promise for improving the overall health of cancer survivors, at least in the short term.

Increasing Life-Space Mobility in Community-Dwelling Older Persons With Cognitive Impairment Following Rehabilitation: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Phoebe Ullrich ◽  
Christian Werner ◽  
Martin Bongartz ◽  
Tobias Eckert ◽  
Bastian Abel ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Older Persons ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Life Space ◽  
Home Based ◽  
Independent Life

Abstract Background Community-dwelling older persons with cognitive impairment (CI) following discharge from geriatric rehabilitation are at high risk of losing life-space mobility (LSM). Interventions to improve their LSM are, however, still lacking. The aim of this study was to evaluate the effects of a CI-specific, home-based physical training and activity promotion program on LSM. Methods Older persons with mild-to-moderate CI (Mini-Mental State Examination: 17–26 points) discharged home from rehabilitation were included in this double-blinded, randomized, placebo-controlled trial with a 12-week intervention period and 12-week follow-up period. The intervention group received a CI-specific, home-based strength, balance, and walking training supported by tailored motivational strategies. The control group received a placebo activity. LSM was evaluated by the Life-Space Assessment in Persons with Cognitive Impairment, including a composite score for LSM and 3 subscores for maximal, equipment-assisted, and independent life space. Mixed-model repeated-measures analyses were used. Results One hundred eighteen participants (82.3 ± 6.0 years) with CI (Mini-Mental State Examination: 23.3 ± 2.4) were randomized. After the intervention, the home-based training program resulted in a significant benefit in the Life-Space Assessment in Persons with Cognitive Impairment composite scores (b = 8.15; 95% confidence interval: 2.89–13.41; p = .003) and independent life-space subscores (b = 0.39; 95% confidence interval: 0.00–0.78; p = .048) in the intervention group (n = 63) compared to control group (n = 55). Other subscores and follow-up results were not significantly different. Conclusions The home-based training program improved LSM and independent life space significantly in this vulnerable population. Effects were not sustained over the follow-up. The program may represent a model for improved transition from rehabilitation to the community to prevent high risk of LSM restriction.

scholarly journals Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
S van Wessel ◽  
T Hamerlynck ◽  
V Schutyser ◽  
C Tomassetti ◽  
C Wyns ◽  
...  
Keyword(s):  
Live Birth ◽  
Financial Support ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Fertility Treatment ◽  
Control Group ◽  
Women Of Reproductive Age ◽  
Operative Hysteroscopy ◽  
Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Functional electrical stimulation‐assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-215755
Author(s):  
Petr Waldauf ◽  
Natália Hrušková ◽  
Barbora Blahutova ◽  
Jan Gojda ◽  
Tomáš Urban ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Randomised Controlled Trial ◽  
Functional Electrical Stimulation ◽  
Controlled Trial ◽  
Cycle Ergometry ◽  
Control Group ◽  
Mechanically Ventilated ◽  
Icu Discharge ◽  
Randomised Controlled

PurposeFunctional electrical stimulation-assisted cycle ergometry (FESCE) enables in-bed leg exercise independently of patients’ volition. We hypothesised that early use of FESCE-based progressive mobility programme improves physical function in survivors of critical care after 6 months.MethodsWe enrolled mechanically ventilated adults estimated to need >7 days of intensive care unit (ICU) stay into an assessor-blinded single centre randomised controlled trial to receive either FESCE-based protocolised or standard rehabilitation that continued up to day 28 or ICU discharge.ResultsWe randomised in 1:1 ratio 150 patients (age 61±15 years, Acute Physiology and Chronic Health Evaluation II 21±7) at a median of 21 (IQR 19–43) hours after admission to ICU. Mean rehabilitation duration of rehabilitation delivered to intervention versus control group was 82 (IQR 66–97) versus 53 (IQR 50–57) min per treatment day, p<0.001. At 6 months 42 (56%) and 46 (61%) patients in interventional and control groups, respectively, were alive and available to follow-up (81.5% of prespecified sample size). Their Physical Component Summary of SF-36 (primary outcome) was not different at 6 months (50 (IQR 21–69) vs 49 (IQR 26–77); p=0.26). At ICU discharge, there were no differences in the ICU length of stay, functional performance, rectus femoris cross-sectional diameter or muscle power despite the daily nitrogen balance was being 0.6 (95% CI 0.2 to 1.0; p=0.004) gN/m2 less negative in the intervention group.ConclusionEarly delivery of FESCE-based protocolised rehabilitation to ICU patients does not improve physical functioning at 6 months in survivors.Trial registration numberNCT02864745.

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