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Intensive Care Unit PatientsNCT05342129

Effects of Exercise Intervention on Muscle Strength in Severely Ill Patients

A study testing exercise bike in people with Intensive Care Unit Patients, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In recent years, due to the improvement in the survival rate of the intensive care unit, the problem of severe systemic fatigue (Intensive care unit acquired weakness; ICUAW) has continued to receive attention. Muscle mass decreases by 3-11% within a week, resulting in decreased muscle strength and muscle atrophy. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Intensive Care Unit Patients
What is being tested?
exercise bike
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
17 Jul 2020to 1 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged over 20 years old
  • Conscious
  • willing to participate in this study, and signed the consent form
  • no lower extremity activity taboo, and can walk independently before admission

Who cannot join

  • Have neuromuscular disease.
  • Unable to step on a bed bike.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • TaipeiVGH

    Taipei, Taipei City, Taiwan

Other trials in Taiwan

About this study

In recent years, due to the improvement in the survival rate of the intensive care unit, the problem of severe systemic fatigue (Intensive care unit acquired weakness; ICUAW) has continued to receive attention. Muscle mass decreases by 3-11% within a week, resulting in decreased muscle strength and muscle atrophy. Current studies suggest that ICUAW can lead to poorer function, prolonged ICU stay, and decreased quality of life.

This study aimed to understand the muscle strength of critically ill patients and to explore the effect of exercise intervention on improving muscle strength. The experimental group received a four-week exercise bike intervention plus conventional rehabilitation exercises, while the control group received conventional rehabilitation exercises.

Read the detailed description

The content of the exercise is to use an exercise bike, start pedaling on the first day, time setting: 20 minutes, speed: 2, and adopt passive mode. If you can complete the exercise on the first day, the time will be adjusted to 30 minutes on the second day. If you cannot complete the exercise on the first day, the time will still start from 20 minutes on the second day. The maximum time is 30 minutes. If you can complete 30 minutes of passive exercise for 3 consecutive days, the fourth day will be adjusted to active exercise. The entire exercise training is seven days a week, once a day, once a 30-minute, at least 5 days. Those who were discharged to the general ward continued to complete this exercise training for up to 28 days. Stop exercising if heartbeat > 140, mean arterial pressure < 65, blood oxygen < 90%, respiration > 35 beats/min, or the patient requests to stop during exercise.

Being tested
exercise bike
Keywords
Intensive care unit patients, exercise Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exercise bikeOther

    exercise is to use an exercise bike, start pedaling on the first day, time setting: 20 minutes, speed: 2, and adopt passive mode. If you can complete the exercise on the first day, the time will be adjusted to 30 minutes on the second day. If you cannot complete the exercise on the first day, the time will still start from 20 minutes on the second day. The maximum time is 30 minutes. If you can complete 30 minutes of passive exercise for 3 consecutive days, the fourth day will be adjusted to active exercise. The entire exercise training is seven days a week, once a day, once a 30-minute, at least 5 days. Those who were discharged to the general ward continued to complete this exercise training for up to 28 days.

Study groups in NCT05342129
Study groupRoleWhat they receive
exercise bikeExperimentalexercise is to use an exercise bike, start pedaling on the first day, time setting: 20 minutes, speed: 2, and adopt passive mode. If you can complete the exercise on the first day, the time will be adjusted to 30 minutes on the second day. If you cannot complete the exercise on the first day, the time will still start from 20 minutes on the second day. The maximum time is 30 minutes. If you can complete 30 minutes of passive exercise for 3 consecutive days, the fourth day will be adjusted to active exercise. The entire exercise training is seven days a week, once a day, once a 30-minute, at least 5 days. Those who were discharged to the general ward continued to complete this exercise training for up to 28 days.
Receives: Other: exercise bike
regular rehabilitation exercisesNo interventionwalking exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Basic Demographic Health Assessment Form

    Age, sex, diagnosis, disease severity, reason for ICU admission

    Measured: baseline

  2. days in intensive care unit

    Health Assessment Form

    Measured: baseline

  3. days on ventilator

    Health Assessment Form

    Measured: baseline

  4. total days in hospital

    Health Assessment Form

    Measured: baseline

  5. body mass index

    Health Assessment Form

    Measured: baseline

  6. level of albumin

    Health Assessment Form

    Measured: baseline

  7. The daily observation record sheet includes

    Vital signs,respirator is used or not,bicycle use pattern,speed and time,reasons for stopping

    Measured: up to 28 days

Secondary outcomes (24)

  1. Hand grip strength

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

    Measured: baseline(T0)

  2. Hand grip strength

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

    Measured: 3 days after intervention(T1)

  3. Hand grip strength

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

    Measured: 7 days after intervention(T2)

  4. Hand grip strength

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

    Measured: 10 days after intervention(T3)

  5. Hand grip strength

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

    Measured: 14 days after intervention(T4)

  6. Hand grip strength

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

    Measured: 17 days after intervention(T5)

  7. Hand grip strength

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

    Measured: 21 days after intervention(T6)

  8. Hand grip strength

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

    Measured: 28 days after intervention(T7)

  9. foot lift

    Use a tape to measure foot lift

    Measured: baseline(T0)

  10. foot lift

    Use a tape to measure foot lift

    Measured: 3 days after intervention(T1)

  11. foot lift

    Use a tape to measure foot lift

    Measured: 7days after intervention(T2)

  12. foot lift

    Use a tape to measure foot lift

    Measured: 10days after intervention(T3)

  13. foot lift

    Use a tape to measure foot lift

    Measured: 14days after intervention(T4)

  14. foot lift

    Use a tape to measure foot lift

    Measured: 17ays after intervention(T5)

  15. foot lift

    Use a tape to measure foot lift

    Measured: 21days after intervention(T6)

  16. foot lift

    Use a tape to measure foot lift

    Measured: 28days after intervention(T7)

  17. walking distance in 6 minutes

    Measure 6-minute walking distance

    Measured: baseline(T0)

  18. walking distance in 6 minutes

    Measure 6-minute walking distance

    Measured: 3 days after intervention(T1)

  19. walking distance in 6 minutes

    Measure 6-minute walking distance

    Measured: 7 days after intervention(T2)

  20. walking distance in 6 minutes

    Measure 6-minute walking distance

    Measured: 10days after intervention(T3)

  21. walking distance in 6 minutes

    Measure 6-minute walking distance

    Measured: 14days after intervention(T4)

  22. walking distance in 6 minutes

    Measure 6-minute walking distance

    Measured: 17days after intervention(T5)

  23. walking distance in 6 minutes

    Measure 6-minute walking distance

    Measured: 21days after intervention(T6)

  24. walking distance in 6 minutes

    Measure 6-minute walking distance

    Measured: 28ays after intervention(T7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start17 Jul 2020
  3. Primary completion1 Mar 2022
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05342129
Sponsor's protocol ID
2020-07-022B
Status last verified
Apr 2022
First submitted
2 Mar 2022
Last updated
22 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.

    PubMed 18511703

  • Camargo Pires-Neto R, Fogaca Kawaguchi YM, Sayuri Hirota A, Fu C, Tanaka C, Caruso P, Park M, Ribeiro Carvalho CR. Very early passive cycling exercise in mechanically ventilated critically ill patients: physiological and safety aspects--a case series. PLoS One. 2013 Sep 9;8(9):e74182. doi: 10.1371/journal.pone.0074182. eCollection 2013.

    PubMed 24040200

  • De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

    PubMed 12472328

  • Eggmann S, Verra ML, Luder G, Takala J, Jakob SM. Effects of early, combined endurance and resistance training in mechanically ventilated, critically ill patients: A randomised controlled trial. PLoS One. 2018 Nov 14;13(11):e0207428. doi: 10.1371/journal.pone.0207428. eCollection 2018.

    PubMed 30427933

  • Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, Casaer MP, Meersseman P, Debaveye Y, Van Cromphaut S, Wouters PJ, Gosselink R, Van den Berghe G. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014 Aug 15;190(4):410-20. doi: 10.1164/rccm.201312-2257OC.

    PubMed 24825371

  • Kho ME, Molloy AJ, Clarke FJ, Ajami D, McCaughan M, Obrovac K, Murphy C, Camposilvan L, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Zanni JM, Mourtzakis M, Piraino T, Cook DJ; Canadian Critical Care Trials Group. TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients. PLoS One. 2016 Dec 28;11(12):e0167561. doi: 10.1371/journal.pone.0167561. eCollection 2016.

    PubMed 28030555

  • Kho ME, Molloy AJ, Clarke FJ, Reid JC, Herridge MS, Karachi T, Rochwerg B, Fox-Robichaud AE, Seely AJ, Mathur S, Lo V, Burns KE, Ball IM, Pellizzari JR, Tarride JE, Rudkowski JC, Koo K, Heels-Ansdell D, Cook DJ. Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients. BMJ Open Respir Res. 2019 Feb 18;6(1):e000383. doi: 10.1136/bmjresp-2018-000383. eCollection 2019.

    PubMed 30956804

  • Machado ADS, Pires-Neto RC, Carvalho MTX, Soares JC, Cardoso DM, Albuquerque IM. Effects that passive cycling exercise have on muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients: a randomized clinical trial. J Bras Pneumol. 2017 Mar-Apr;43(2):134-139. doi: 10.1590/S1806-37562016000000170.

    PubMed 28538781

Questions about this trial

What is this clinical trial studying?

A study testing exercise bike in people with Intensive Care Unit Patients, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Basic Demographic Health Assessment Form (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05342129, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

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