Clinical trial NCT05342129: Effects of Exercise Intervention on Muscle Strength in Severely Ill Patients
Official title: Effects of Exercise Intervention on Muscle Strength in Severely Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Patients
Keywords: Intensive care unit patients, exercise Training
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Basic Demographic Health Assessment Form
timeFrame: baseline
measure: days in intensive care unit
timeFrame: baseline
measure: days on ventilator
timeFrame: baseline
measure: total days in hospital
timeFrame: baseline
measure: body mass index
timeFrame: baseline
measure: level of albumin
timeFrame: baseline
measure: The daily observation record sheet includes
timeFrame: up to 28 days
Secondary outcomes:
measure: Hand grip strength
timeFrame: baseline(T0)
measure: Hand grip strength
timeFrame: 3 days after intervention(T1)
measure: Hand grip strength
timeFrame: 7 days after intervention(T2)
measure: Hand grip strength
timeFrame: 10 days after intervention(T3)
measure: Hand grip strength
timeFrame: 14 days after intervention(T4)
measure: Hand grip strength
timeFrame: 17 days after intervention(T5)
measure: Hand grip strength
timeFrame: 21 days after intervention(T6)
measure: Hand grip strength
timeFrame: 28 days after intervention(T7)
measure: foot lift
timeFrame: baseline(T0)
measure: foot lift
timeFrame: 3 days after intervention(T1)
measure: foot lift
timeFrame: 7days after intervention(T2)
measure: foot lift
timeFrame: 10days after intervention(T3)
measure: foot lift
timeFrame: 14days after intervention(T4)
measure: foot lift
timeFrame: 17ays after intervention(T5)
measure: foot lift
timeFrame: 21days after intervention(T6)
measure: foot lift
timeFrame: 28days after intervention(T7)
measure: walking distance in 6 minutes
timeFrame: baseline(T0)
measure: walking distance in 6 minutes
timeFrame: 3 days after intervention(T1)
measure: walking distance in 6 minutes
timeFrame: 7 days after intervention(T2)
measure: walking distance in 6 minutes
timeFrame: 10days after intervention(T3)
measure: walking distance in 6 minutes
timeFrame: 14days after intervention(T4)
measure: walking distance in 6 minutes
timeFrame: 17days after intervention(T5)
measure: walking distance in 6 minutes
timeFrame: 21days after intervention(T6)
measure: walking distance in 6 minutes
timeFrame: 28ays after intervention(T7)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TaipeiVGH
state: Taipei City, Taiwan
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Tao-Fen Hsiung
role: STUDY_DIRECTOR
References:
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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 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.
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