Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT03394495
Eligibility Criteria:
Inclusion Criteria:
* community-dwelling older people aged \> 70 years;
* able to communicate in Cantonese to ensure that they understand our instructions;
* able to walk with or without an assistive device and able to complete the Time Up and Go (TUG) test with no specific cutoff point to ensure that their mobility and balance is good enough to join the exercise training; and
* in a frail state with exhaustion as determined using the Fried Frailty Index (FFI), including: i) an unintentional loss of 10% of body weight in the past year; ii) exhaustion: by answering 'Yes' to either 'I felt that everything I did was an effort', or 'I could not get going in the last week'; iii) a slow walk time: with an average walking speed in the lowest quintile stratified by median body height; iv) reduced grip strength: with maximal grip strength in the lowest quintile stratified by body mass index quartile; and v) the Physical Activity Scale for the Elderly-Chinese (PASE-C) score in the lowest quintile (i.e., \< 30 for men and \< 27.7 for women). The presence of \> 3 items indicates frailty, and one criterion indicates that they suffer from exhaustion.
Exclusion Criteria: are older people who:
* are suffering from any disease in which fatigue is a dominant symptom (such as neurodegenerative diseases, cancer, and end-stage renal failure cachexia cases;
* have been hospitalized for \> 5 days in the preceding 3 months, which may lead to muscle wasting due to recent bed rest or reduced activity levels during hospitalization;
* underwent major surgery (such as total joint replacement, major abdominal surgeries) during the last 6 months;
* are confined to bed or restricted by the permanent use of a wheelchair;
* report that they regularly perform moderately intense exercise (such as hiking, Tai Chi) for \> 3 hours per week;
* are terminally ill;
* have been diagnosed with major depression entailing frequent adjustments of their antidepressants to control unstable depressive moods. The criteria were chosen to avoid recruiting people with depression-induced fatigue. However, a consistent feeling of fatigue may manifest as a depressed mood. Thus, the participants' mood will be assessed using the Chinese-Geriatric Depression Scale (C-GDS).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT03394495
Study Brief:
Protocol Section:
NCT03394495