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NCT Number: NCT02377830

CYCLE Pilot Randomized Trial

Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the ICU.

Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed cycling each day they are in the ICU or routine physiotherapy, both delivered by specially trained physiotherapists.

Outcomes: Feasibility: The investigators will study whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether investigators can systematically assess patients' strength.

Relevance: Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized study is the second of several future larger studies about in-bed cycling in the ICU.

Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).

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Key information

Conditions

Intensive Care Unit Acquired Weakness Critical Care Mechanical Ventilation Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Austin Health, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults admitted to a medical-surgical ICU within the 1st 4 days of mechanical ventilation (MV) and 1st 7 days of ICU, and
  • could ambulate independently before hospital admission.

Exclusion criteria

  • Acute condition impairing patients' ability to cycle (e.g., leg fracture),
  • proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or Guillain-Barré syndrome),
  • unable to follow commands in English pre-ICU,
  • temporary pacemaker,
  • expected hospital mortality >90%,
  • unable to fit the bike, palliative goals of care, or persistent therapy exemptions in the 1st 4 days of MV (e.g., cardiorespiratory instability, active major bleeding)

Treatment and study plan

In-bed cycle ergometer (Restorative Therapies RT300 Supine)

Device

Other names: Restorative Therapies RT300 Supine

Routine physiotherapy

Other

activities to assist with optimizing airway clearance and respiratory function, and, 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, and ambulation

Primary outcomes

  1. Patient accrual

    Time frame: 2 years

Secondary outcomes

  1. Cycling protocol violations (% cycling protocol violations)

    Time frame: 2 years

    % cycling protocol violations

  2. Outcome measure ascertainment (% outcomes measured in hospital)

    Time frame: 2 years

    % outcomes measured in hospital

  3. Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)

    Time frame: 2 years

    % outcomes at hospital discharge measured by blinded outcome assessors

  4. Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge

    Time frame: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively

    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

  5. Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge

    Time frame: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively

    Manual muscle testing using the Medical Research Council (MRC) Scale. The patient exerts a force against the examiner's resistance. Each muscle is assessed on a 6-point MRC scale (0=no contraction; 5=contraction sustained against maximal resistance).

  6. Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale)

    Time frame: From study admission to approximately 12 and 30 days, on average, respectively

    The patient exerts a force against a small strain gauge that fits in the examiner's hand. .

  7. 2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge

    Time frame: From study admission to approximately 12 and 30 days, on average, respectively

    Maximum distance walked in 2 minutes measured in metres on a continuous scale

Other outcomes

  1. Katz Activities of Daily Living Scale at ICU and hospital discharge

    Time frame: From study admission to approximately 12 and 30 days, on average, respectively

    The patient's ability to complete 6 tasks: bathing, dressing, toileting, feeding, continence, and bed mobility. A rater assesses whether the patient is dependent or independent according to pre-specified criteria.

  2. Euro-QOL 5DL

    Time frame: From study admission to approximately 12 and 30 days, on average, respectively

    5 question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/ depression, as well as a global assessment of health

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Canadian Respiratory Research Network
  • Hamilton Health Sciences Corporation
  • Ontario Lung Association
  • St. Joseph's Healthcare Hamilton
  • Technology Evaluation in the Elderly Network / Canadian Frailty Network

Registry information

Official study title

CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients

Acronym: CYCLE Pilot

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2015
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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