Effects of Exercise Intervention on Muscle Strength in Severely Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Patients
• Intervention / Treatment: Other: exercise bike

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan
    • Taipei, Taipei City, Taiwan, Taiwan
      • TaipeiVGH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Have neuromuscular disease.
2. Unable to step on a bed bike.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: exercise bike; 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.	Other: exercise bike; 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.
NO_INTERVENTION: regular rehabilitation exercises; walking exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Basic Demographic Health Assessment Form	Age, sex, diagnosis, disease severity, reason for ICU admission	baseline
days in intensive care unit	Health Assessment Form	baseline
days on ventilator	Health Assessment Form	baseline
total days in hospital	Health Assessment Form	baseline
body mass index	Health Assessment Form	baseline
level of albumin	Health Assessment Form	baseline
The daily observation record sheet includes	Vital signs,respirator is used or not,bicycle use pattern,speed and time,reasons for stopping	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	baseline(T0)
Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	3 days after intervention(T1)
Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	7 days after intervention(T2)
Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	10 days after intervention(T3)
Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	14 days after intervention(T4)
Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	17 days after intervention(T5)
Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	21 days after intervention(T6)
Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	28 days after intervention(T7)
foot lift	Use a tape to measure foot lift	baseline(T0)
foot lift	Use a tape to measure foot lift	3 days after intervention(T1)
foot lift	Use a tape to measure foot lift	7days after intervention(T2)
foot lift	Use a tape to measure foot lift	10days after intervention(T3)
foot lift	Use a tape to measure foot lift	14days after intervention(T4)
foot lift	Use a tape to measure foot lift	17ays after intervention(T5)
foot lift	Use a tape to measure foot lift	21days after intervention(T6)
foot lift	Use a tape to measure foot lift	28days after intervention(T7)
walking distance in 6 minutes	Measure 6-minute walking distance	baseline(T0)
walking distance in 6 minutes	Measure 6-minute walking distance	3 days after intervention(T1)
walking distance in 6 minutes	Measure 6-minute walking distance	7 days after intervention(T2)
walking distance in 6 minutes	Measure 6-minute walking distance	10days after intervention(T3)
walking distance in 6 minutes	Measure 6-minute walking distance	14days after intervention(T4)
walking distance in 6 minutes	Measure 6-minute walking distance	17days after intervention(T5)
walking distance in 6 minutes	Measure 6-minute walking distance	21days after intervention(T6)
walking distance in 6 minutes	Measure 6-minute walking distance	28ays after intervention(T7)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Director: Tao-Fen Hsiung, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2020
• Primary Completion (ACTUAL): March 1, 2022
• Study Completion (ACTUAL): March 1, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (ACTUAL): April 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Intensive care unit patients, exercise Training
• Other Study ID Numbers: 2020-07-022B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No