Effects of Exercise Intervention on Muscle Strength in Severely Ill Patients

Intensive Care Unit Patients Clinical Trial

Official title:

Effects of Exercise Intervention on Muscle Strength in Severely Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05342129
• Other study ID #: 2020-07-022B
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intensive Care Unit Patients

Intervention

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.

Locations

Country	Name	City	State
Taiwan	TaipeiVGH	Taipei	Taipei City, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

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 — View Citation

Camargo Pires-Neto R, Fogaça 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. PLo — View Citation

De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphaël JC, Outin H, Bastuji-Garin S; Groupe de Réflexion et d'Etude des Neuromyopathies en Réanimation. Paresis acquired in the int — View Citation

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. — View Citation

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 c — View Citation

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 Safet — View Citation

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 — View Citation

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 clinic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basic Demographic Health Assessment Form	Age, sex, diagnosis, disease severity, reason for ICU admission	baseline
Primary	days in intensive care unit	Health Assessment Form	baseline
Primary	days on ventilator	Health Assessment Form	baseline
Primary	total days in hospital	Health Assessment Form	baseline
Primary	body mass index	Health Assessment Form	baseline
Primary	level of albumin	Health Assessment Form	baseline
Primary	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	Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	baseline(T0)
Secondary	Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	3 days after intervention(T1)
Secondary	Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	7 days after intervention(T2)
Secondary	Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	10 days after intervention(T3)
Secondary	Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	14 days after intervention(T4)
Secondary	Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	17 days after intervention(T5)
Secondary	Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	21 days after intervention(T6)
Secondary	Hand grip strength	Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength	28 days after intervention(T7)
Secondary	foot lift	Use a tape to measure foot lift	baseline(T0)
Secondary	foot lift	Use a tape to measure foot lift	3 days after intervention(T1)
Secondary	foot lift	Use a tape to measure foot lift	7days after intervention(T2)
Secondary	foot lift	Use a tape to measure foot lift	10days after intervention(T3)
Secondary	foot lift	Use a tape to measure foot lift	14days after intervention(T4)
Secondary	foot lift	Use a tape to measure foot lift	17ays after intervention(T5)
Secondary	foot lift	Use a tape to measure foot lift	21days after intervention(T6)
Secondary	foot lift	Use a tape to measure foot lift	28days after intervention(T7)
Secondary	walking distance in 6 minutes	Measure 6-minute walking distance	baseline(T0)
Secondary	walking distance in 6 minutes	Measure 6-minute walking distance	3 days after intervention(T1)
Secondary	walking distance in 6 minutes	Measure 6-minute walking distance	7 days after intervention(T2)
Secondary	walking distance in 6 minutes	Measure 6-minute walking distance	10days after intervention(T3)
Secondary	walking distance in 6 minutes	Measure 6-minute walking distance	14days after intervention(T4)
Secondary	walking distance in 6 minutes	Measure 6-minute walking distance	17days after intervention(T5)
Secondary	walking distance in 6 minutes	Measure 6-minute walking distance	21days after intervention(T6)
Secondary	walking distance in 6 minutes	Measure 6-minute walking distance	28ays after intervention(T7)