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Completed

NCT Number: NCT05342129

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.

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Key information

Conditions

Intensive Care Unit Patients

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TaipeiVGH

Taipei, Taipei City, Taiwan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

exercise bike

Other

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.

Primary outcomes

  1. Basic Demographic Health Assessment Form

    Time frame: baseline

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

  2. days in intensive care unit

    Time frame: baseline

    Health Assessment Form

  3. days on ventilator

    Time frame: baseline

    Health Assessment Form

  4. total days in hospital

    Time frame: baseline

    Health Assessment Form

  5. body mass index

    Time frame: baseline

    Health Assessment Form

  6. level of albumin

    Time frame: baseline

    Health Assessment Form

  7. The daily observation record sheet includes

    Time frame: up to 28 days

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

Secondary outcomes

  1. Hand grip strength

    Time frame: baseline(T0)

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

  2. Hand grip strength

    Time frame: 3 days after intervention(T1)

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

  3. Hand grip strength

    Time frame: 7 days after intervention(T2)

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

  4. Hand grip strength

    Time frame: 10 days after intervention(T3)

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

  5. Hand grip strength

    Time frame: 14 days after intervention(T4)

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

  6. Hand grip strength

    Time frame: 17 days after intervention(T5)

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

  7. Hand grip strength

    Time frame: 21 days after intervention(T6)

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

  8. Hand grip strength

    Time frame: 28 days after intervention(T7)

    Using a Grip Strength Tester to Measure Dominant Hand Muscle Strength

  9. foot lift

    Time frame: baseline(T0)

    Use a tape to measure foot lift

  10. foot lift

    Time frame: 3 days after intervention(T1)

    Use a tape to measure foot lift

  11. foot lift

    Time frame: 7days after intervention(T2)

    Use a tape to measure foot lift

  12. foot lift

    Time frame: 10days after intervention(T3)

    Use a tape to measure foot lift

  13. foot lift

    Time frame: 14days after intervention(T4)

    Use a tape to measure foot lift

  14. foot lift

    Time frame: 17ays after intervention(T5)

    Use a tape to measure foot lift

  15. foot lift

    Time frame: 21days after intervention(T6)

    Use a tape to measure foot lift

  16. foot lift

    Time frame: 28days after intervention(T7)

    Use a tape to measure foot lift

  17. walking distance in 6 minutes

    Time frame: baseline(T0)

    Measure 6-minute walking distance

  18. walking distance in 6 minutes

    Time frame: 3 days after intervention(T1)

    Measure 6-minute walking distance

  19. walking distance in 6 minutes

    Time frame: 7 days after intervention(T2)

    Measure 6-minute walking distance

  20. walking distance in 6 minutes

    Time frame: 10days after intervention(T3)

    Measure 6-minute walking distance

  21. walking distance in 6 minutes

    Time frame: 14days after intervention(T4)

    Measure 6-minute walking distance

  22. walking distance in 6 minutes

    Time frame: 17days after intervention(T5)

    Measure 6-minute walking distance

  23. walking distance in 6 minutes

    Time frame: 21days after intervention(T6)

    Measure 6-minute walking distance

  24. walking distance in 6 minutes

    Time frame: 28ays after intervention(T7)

    Measure 6-minute walking distance

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Apr 22, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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