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Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients.

ABSTRACT: Introduction:Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient's ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients. Methods:We conducted a pilot RCT conducted in seven Canadian medical-surgical ICUs. We enrolled adults who could ambulate independently before ICU admission, within the first 4 days of invasive MV and first 7 days of ICU admission. Following informed consent, patients underwent concealed randomisation to either 30?min/day of in-bed cycling and routine physiotherapy (Cycling) or routine physiotherapy alone (Routine) for 5?days/week, until ICU discharge. Our feasibility outcome targets included: accrual of 1-2 patients/month/site; >80% cycling protocol delivery; >80% outcomes measured and >80% blinded outcome measures at hospital discharge. We report ascertainment rates for our primary outcome for the main trial (Physical Function ICU Test-scored (PFIT-s) at hospital discharge). Results:Between 3/2015 and 6/2016, we randomised 66 patients (36 Cycling, 30 Routine). Our consent rate was 84.6 % (66/78). Patient accrual was (mean (SD)) 1.1 (0.3) patients/month/site. Cycling occurred in 79.3% (146/184) of eligible sessions, with a median (IQR) session duration of 30.5 (30.0, 30.7) min. We recorded 43 (97.7%) PFIT-s scores at hospital discharge and 37 (86.0%) of these assessments were blinded. Discussion:Our pilot RCT suggests that a future multicentre RCT of early in-bed cycling for MV patients in the ICU is feasible. Trial registration number:NCT02377830.

SUBMITTER: Kho ME

PROVIDER: S-EPMC6424272 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients.

Kho Michelle E ME Molloy Alexander J AJ Clarke France J FJ Reid Julie C JC Herridge Margaret S MS Karachi Timothy T Rochwerg Bram B Fox-Robichaud Alison E AE Seely Andrew Je AJ Mathur Sunita S Lo Vincent V Burns Karen Ea KE Ball Ian M IM Pellizzari Joseph R JR Tarride Jean-Eric JE Rudkowski Jill C JC Koo Karen K Heels-Ansdell Diane D Cook Deborah J DJ

BMJ open respiratory research 20190218 1

<h4>Introduction</h4>Acute rehabilitation in critically ill patients can improve post-intensive care unit (post-ICU) physical function. In-bed cycling early in a patient's ICU stay is a promising intervention. The objective of this study was to determine the feasibility of recruitment, intervention delivery and retention in a multi centre randomised clinical trial (RCT) of early in-bed cycling with mechanically ventilated (MV) patients.<h4>Methods</h4>We conducted a pilot RCT conducted in seven ...[more]

PMID: 30956804

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Project description:IntroductionSurvivors of critical illness often experience significant morbidities, including muscle weakness and impairments in physical functioning. This muscle weakness is associated with longer duration mechanical ventilation, greater hospital costs and increased postdischarge impairments in physical function, quality of life and survival. Compared with standard of care, the benefits of greater protein intake combined with structured exercise started early after the onset of critical illness remain uncertain. However, the combination of protein supplementation and exercise in other populations has demonstrated positive effects on strength and function. In the present study, we will evaluate the effects of a combination of early implementation of intravenous amino acid supplementation and in-bed cycle ergometry exercise versus a 'usual care' control group in patients with acute respiratory failure requiring mechanical ventilation in an intensive care unit (ICU).Methods and analysisIn this multicentre, assessor-blinded, randomised controlled trial, we will randomise 142 patients in a 1:1 ratio to usual care (which commonly consists of minimal exercise and under-achievement of guideline-recommended caloric and protein intake goals) versus a combined intravenous amino acid supplementation and in-bed cycle ergometery exercise intervention. We hypothesise that this novel combined intervention will (1) improve physical functioning at hospital discharge; (2) reduce muscle wasting with improved amino acid metabolism and protein synthesis in-hospital and (3) improve patient-reported outcomes and healthcare resource utilisation at 6 months after enrolment. Key cointerventions will be standardised. In-hospital outcome assessments will be conducted at baseline, ICU discharge and hospital discharge. An intent-to-treat analysis will be used to analyse all data with additional per-protocol analyses.Ethics and disseminationThe trial received ethics approval at each institution and enrolment has begun. These results will inform both clinical practice and future research in the area. We plan to disseminate trial results in peer-reviewed journals, at national and international conferences, and via nutritional and rehabilitation-focused electronic education and knowledge translation platforms.Trial registration numberNCT03021902; Pre-results.

Project description:BACKGROUND:Clinical trials management can be studied using project management theory. The CYCLE pilot randomized controlled trial (RCT) was conducted to determine the feasibility of a future rehabilitation trial of early in-bed cycling in the intensive care unit (ICU). In-bed cycling is a novel intervention, not typically available in ICUs. Implementation of this intervention requires personnel with specialized clinical expertise caring for critically ill patients and use of the in-bed cycle. Our objective was to describe the implementation and conduct of our pilot RCT using a project management approach. METHODS:We retrospectively reviewed activities, timelines, and personnel involved in the trial. We organized activities into four project management phases: initiation, planning, execution, and monitoring and controlling. Data sources included Methods Centre documents used for trial coordination and conduct, and the trial data set. We report descriptive statistics as counts and proportions and also medians and quartiles, and we summarize the lessons learned. RESULTS:Seven ICUs in Canada participated in the trial. Time from research ethics board and contracts submission to first enrolment was a median (first quartile, third quartile) of 185 (146, 209) and 162 (114, 181) days, respectively. We trained 128 personnel on the CYCLE pilot RCT protocol, and 80 (63%) completed trial-related activities. Four sites required additional training after start-up due to staff turnover and leaves of absence. Over 15?months, we screened 864 patients: 256 were eligible and 66 were enrolled. Despite an 85% consent rate, 74% (190/256) of eligible patients were not randomized, largely (80% [152/190]) due to physiotherapist availability. Thirteen percent of recruitment weeks were lost due to physiotherapist staffing shortages. We highlight five key lessons learned: (1) prepare and anticipate site needs; (2) communicate regularly; (3) proactively analyse and act on process measure data; (4) develop contingency plans; (5) express appreciation to participating sites. CONCLUSIONS:Our analysis highlights the scope of relevant activities, rigorous training and monitoring, number and types of required personnel, and time required to conduct a multicentre ICU rehabilitation intervention trial. Our lessons learned can help others interested in implementing complex intervention trials, such as rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02377830 . Registered prospectively on 4 March 2015.

Project description:Despite the increasing use of hip arthroscopy for hip pain, there is no level 1 evidence to support physiotherapy rehabilitation programs following this procedure. The aims of this study were to determine (i) what is the feasibility of a randomised controlled trial (RCT) investigating a targeted physiotherapy intervention for early-onset hip osteoarthritis (OA) post-hip arthroscopy? and (ii) what are the within-group treatment effects of the physiotherapy intervention and a health-education control group?This study was a pilot single-blind RCT conducted in a private physiotherapy clinic in Hobart, Australia. Patients included 17 volunteers (nine women; age 32 ± 8 years; body mass index = 25.6 ± 5.1 kg/m2) who were recruited 4-14 months post-hip arthroscopy, with chondropathy and/or labral pathology at the time of surgery. Interventions included a physiotherapy treatment program that was semi-standardised and consisted of (i) manual therapy; (ii) hip strengthening and functional retraining; and (iii) health education. Control treatment encompassed individualised health education sessions. The primary outcome measure was feasibility, which was reported as percentage of eligible participants enrolled, adherence with the intervention, and losses to follow-up. The research process was evaluated using interviews, and an estimated sample size for a definitive study is offered. Secondary outcomes included the Hip disability and Osteoarthritis Outcome Score (HOOS) and the International Hip Outcome Tool (IHOT-33) patient-reported outcomes.Seventeen out of 48 eligible patients (35%) were randomised. Adherence to the intervention was 100%, with no losses to follow-up. The estimated sample size for a full-scale RCT was 142 patients. The within-group (95% confidence intervals) change scores for the physiotherapy group were HOOS-Symptoms 6 points (-4 to 16); HOOS-Pain 10 points (-2 to 22); HOOS-Activity of Daily Living 8 points (0 to 16); HOOS-Sport 3 points (-12 to 19); HOOS-Quality of Life 3 points (-7 to 13); and IHOT-33 7 points (-10 to 25). The within-group (95% confidence intervals) change scores for the control group were HOOS-Symptoms -4 points (-17 to 9); HOOS-Pain -2 points (-18 to 13); HOOS-Activity of Daily Living -7 points (-17 to 4); HOOS-Sport 4 points (-16 to 23); HOOS-Quality of Life -5 points (-18 to 9); and IHOT-33 -4 points (-27 to 19). Suggestions to improve study design included greater supervision of exercises and increased access to physiotherapy appointments.Results support the feasibility of a full-scale RCT, and recommendations for an adequately powered and improved study to determine the efficacy of this physiotherapy intervention post-hip arthroscopy to reduce pain and improve function are provided.Australian Clinical Trials Registry, ACTRN12614000426684.

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Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients.

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Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients.

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