CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients

NCT03471247 | Active Not Recruiting DMC

• 1 other identifier: CYCLE RCT
• Study Type: interventional
• Target: 360
• Locations: 3 countries
• Sites: 16

Brief Summary

Patients who survive critical illness usually experience long-lasting physical and psychological impairments, which are often debilitating. Rehabilitation interventions started in the ICU may reduce this morbidity. In-bed cycling, which uses a special bicycle that attaches to the hospital bed, allows critically ill patients who are mechanically ventilated (MV) to gently exercise their legs while in the ICU. The main goal of this study is to determine whether critically ill MV adults recover faster if they receive early in-bed cycling than if they do not. Another objective is to determine whether in-bed cycling is a cost-effective intervention. 360 patients admitted to the ICU and receiving MV will be enrolled in the study. Following informed consent, patients will be randomized to either (1) early in-bed cycling and routine physiotherapy or (2) routine physiotherapy alone. Patients' strength and physical function will be measured throughout the study. If early in-bed cycling during critical illness improves short-term physical and functional outcomes, it could accelerate recovery and reduce long-term disability in ICU survivors.

Conditions

Intensive Care Unit Acquired Weakness; Critical Care; Mechanical Ventilation; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Physical Function Test for ICU-scored (PFIT-s)

  Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function.

  3 days after ICU discharge

Secondary Outcomes (17)

• Physical Function Test for ICU-scored (PFIT-s)

  ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; Hospital Discharge, approximately 28 days after ICU admission

• Muscle Strength

  ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission

• 30 Second Sit to Stand

  ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission

• Two Minute Walk Test

  ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission

• Patient-Reported Functional Scale-ICU (PRFS-ICU)

  ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment

Study Arms (2)

In-Bed Cycle Ergometer + Routine PT

EXPERIMENTAL

Patients will receive 30 minutes of in-bed cycling once per day, 5 days per week, while they remain in the ICU, for up to a maximum of 28 days. They will also receive routine physiotherapy.

Device: In-Bed Cycle Ergometer; Other: Routine PT

Routine PT

ACTIVE COMPARATOR

Patients will receive routine physiotherapy interventions per current institutional practice

Other: Routine PT

Interventions

In-Bed Cycle Ergometer DEVICE

Physiotherapists will place the patient's legs in a specialized in-bed cycle ergometer allowing for gentle leg exercise. Exercise can performed in passive, active-assisted, or active mode.

Also known as: Restorative Therapies RT300 Supine

In-Bed Cycle Ergometer + Routine PT

Routine PT OTHER

Includes, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out- of bed mobility, ambulation, and assistance with optimizing airway clearance and respiratory function.

In-Bed Cycle Ergometer + Routine PT; Routine PT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years of age
• Patient is invasively mechanically ventilated ≤ 4 days
• Expected additional 2 day ICU stay
• Ability to ambulate independently (with or without gait aid) before their critical illness
• ICU length of stay ≤ 7 days

You may not qualify if:

• Pre-hospital inability to follow simple commands in local language at baseline
• Acute conditions impairing ability to receive cycling
• Severe cognitive impairment pre-ICU
• Traumatic brain injury
• Acute proven or suspected central or peripheral neuromuscular weakness affecting the legs (e.g., stroke, Guillian-Barre syndrome, spinal injury)
• Temporary pacemaker (internal or external)
• Expected hospital mortality ≥ 90%
• Equipment unable to fit patient's body dimensions (elg., leg amputation, morbid obesity)
• Palliative goals of care
• Pregnancy (suspected or proven)
• Physician declines
• Cycling exemption not resolved during first 4 days of mechanical ventilation
• Patient already able to march on spot at time of screening

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Critical Care Trials Group: collaborator

Study Sites (16)

University of Maryland Medical Centre

Baltimore, Maryland, 21201, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Austin Health - Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Brant Community Healthcare System - Brantford General Hospital

Brantford, Ontario, N3R 1G9, Canada

Location

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Sciences - Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Kingston Health Sciences Centre - Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Niagara Health System - St. Catharines Site

St. Catharines, Ontario, L2S 0A9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Centre Integre de Sante et de Services Sociaux de Chaudiere-Appalaches - Hotel-Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

Location

Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (4)

• Reid JC, Molloy A, Strong G, Kelly L, O'Grady H, Cook D, Archambault PM, Ball I, Berney S, Burns KEA, D'Aragon F, Duan E, English SW, Lamontagne F, Pastva AM, Rochwerg B, Seely AJE, Serri K, Tsang JLY, Verceles AC, Reeve B, Fox-Robichaud A, Muscedere J, Herridge M, Thabane L, Kho ME; CYCLE Investigators. Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic. Trials. 2022 Sep 2;23(1):735. doi: 10.1186/s13063-022-06640-y.

  PMID: 36056378 BACKGROUND

• Kho ME, Reid J, Molloy AJ, Herridge MS, Seely AJ, Rudkowski JC, Buckingham L, Heels-Ansdell D, Karachi T, Fox-Robichaud A, Ball IM, Burns KEA, Pellizzari JR, Farley C, Berney S, Pastva AM, Rochwerg B, D'Aragon F, Lamontagne F, Duan EH, Tsang JLY, Archambault P, English SW, Muscedere J, Serri K, Tarride JE, Mehta S, Verceles AC, Reeve B, O'Grady H, Kelly L, Strong G, Hurd AH, Thabane L, Cook DJ; CYCLE Investigators and the Canadian Critical Care Trials Group. Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients. BMJ Open. 2023 Jun 23;13(6):e075685. doi: 10.1136/bmjopen-2023-075685.

  PMID: 37355270 BACKGROUND

• Heels-Ansdell D, Kelly L, O'Grady HK, Farley C, Reid JC, Berney S, Pastva AM, Burns KE, D'Aragon F, Herridge MS, Seely A, Rudkowski J, Rochwerg B, Fox-Robichaud A, Ball I, Lamontagne F, Duan EH, Tsang J, Archambault PM, Verceles AC, Muscedere J, Mehta S, English SW, Karachi T, Serri K, Reeve B, Thabane L, Cook D, Kho ME. Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial. JMIR Res Protoc. 2024 Oct 28;13:e54451. doi: 10.2196/54451.

  PMID: 39467285 DERIVED

• Kho ME, Berney S, Pastva AM, Kelly L, Reid JC, Burns KEA, Seely AJ, D'Aragon F, Rochwerg B, Ball I, Fox-Robichaud AE, Karachi T, Lamontagne F, Archambault PM, Tsang JL, Duan EH, Muscedere J, Verceles AC, Serri K, English SW, Reeve BK, Mehta S, Rudkowski JC, Heels-Ansdell D, O'Grady HK, Strong G, Obrovac K, Ajami D, Camposilvan L, Tarride JE, Thabane L, Herridge MS, Cook DJ. Early In-Bed Cycle Ergometry in Mechanically Ventilated Patients. NEJM Evid. 2024 Jul;3(7):EVIDoa2400137. doi: 10.1056/EVIDoa2400137. Epub 2024 Jun 12.

  PMID: 38865147 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Michelle Kho, PT, PhD

  McMaster University School of Rehabilitation Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 20, 2018
• Study Start: October 15, 2018
• Primary Completion: May 26, 2023
• Study Completion: August 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AU (1); CA (13)