Clinical trial NCT04549103: Effect of Baduanjin on Functional Performance in Pre-Frail/Frail Older Adults
Official title: Effect of Community-based Baduanjin (八段锦) on Functional Performance in Pre-Frail/Frail Older Adults: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Frail Elderly Syndrome
Lead sponsor: Geriatric Education and Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: Tsao Foundation
First posted: 2020-09-16
Enrollment: 58
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: The aim for this study is to investigate the effectiveness of a 16-week realistic community-delivered Baduanjin training program compared to a waitlist control intervention, in improving functional outcomes among pre-frail and frail older adults in Singapore. It is hypothesized that participants that receive 16-week of BDJ training will have significant improvement in physical function (including balance, muscle strength, and endurance); alleviate exhaustion; reduce risk of falling and fear of falling; potentially reverse frailty; reduce depression; and improve quality of life, potentially with greater improvements in area(s) for individuals with lower baseline measures. Whereas, participants in the waitlist control group, will have insignificant changes to their baseline measures.


Eligibility criteria: Inclusion Criteria:

* Pre-frail and frail adults aged 55 years and above
* Able to ambulate (move about) without personal assistance and has no other physical limitations affecting participation and adherence
* Able to understand basic instructions
* Generally sedentary lifestyle

Exclusion Criteria:

* Participating in other intervention studies
* Perform regular moderate to vigorous intensity exercise
* Perform regular Taichi or Qigong exercise
* Have severe audio-visual impairment
* Diagnosed with cognitive impairment (e.g. dementia, Alzheimer's Disease) and/or history of neurological disorder (e.g. cerebral palsy, Parkinson's Disease)
* Diagnosed with postural hypotension (have a drop of 20mmHg systolic blood pressure, or a drop of 10mmHg diastolic blood pressure within two to five minutes of standing up, or if standing causes signs and symptoms)
* Unable to participate for the full duration of the study
* Unable to come to the training site by himself/herself or by the help of caregivers
* Not suitable to participate in exercise as deemed by a medical doctor

Primary outcomes:
measure: Change in Knee Extension Strength
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in Maastricht Vital Exhaustion Score (MQ)
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in Falls Efficacy Scale-International (FES-I)
timeFrame: Baseline, and after 16-weeks of intervention
Secondary outcomes:
measure: Change in Physiological Profile Assessment. (PPA - Short Form)
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in Hand Grip Strength
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in 6-meter Fast Gait Speed Test
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in Time Up and Go test (TUG)
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in 30 seconds Sit-to-stand (STS)
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in Frailty Score
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in EuroQol-Five Dimensions (EQ-5D)
timeFrame: Baseline, and after 16-weeks of intervention
measure: Change in Geriatric Depression Scale (GDS)
timeFrame: Baseline, and after 16-weeks of intervention
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yong-en Care Centre
Study officials:
References:
citation: Liu X, Seah JWT, Pang BWJ, Tsao MA, Gu F, Ng WC, Tay JYR, Ng TP, Wee SL. A single-arm feasibility study of community-delivered Baduanjin (Qigong practice of the eight Brocades) training for frail older adults. Pilot Feasibility Stud. 2020 Jul 21;6:105. doi: 10.1186/s40814-020-00649-3. eCollection 2020.