Effect of Baduanjin on Functional Performance in Pre-Frail/Frail Older Adults

NCT04549103 | Completed

• 1 other identifier: TCMG BDJ RCT
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (3)

• Change in Knee Extension Strength

  Knee extension strength is measured using a digital dynamometer gauge. Prior to performing the test, leg dominant is determined by asking participants which is their dominant leg or which leg they would predominantly use when performing a task. For the assessment, participants will be asked to extend their leg against the spring gauge while seated with the hip and knee joint angles positioned at 90°. Maximal force is recorded in kilograms.

  Baseline, and after 16-weeks of intervention

• Change in Maastricht Vital Exhaustion Score (MQ)

  Maastricht vital exhaustion score (MQ) is a short questionnaires that requires between 5 to 10 minutes for completion. MQ is a validated tool to assess feelings of "vital exhaustion", which has three defining characteristics: (1) feeling of excessive fatigue and lack of energy, (2) increased irritability, and (3) feelings of demoralization.

  Baseline, and after 16-weeks of intervention

• Change in Falls Efficacy Scale-International (FES-I)

  The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the fear of falling in older population during social and physical activities inside and outside the home. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned). The 16-item FES-I is a well validated and feasible measure to assess fear of falling in older persons, and predicts future risks of falls.

  Baseline, and after 16-weeks of intervention

Secondary Outcomes (8)

• Change in Physiological Profile Assessment. (PPA - Short Form)

  Baseline, and after 16-weeks of intervention

• Change in Hand Grip Strength

  Baseline, and after 16-weeks of intervention

• Change in 6-meter Fast Gait Speed Test

  Baseline, and after 16-weeks of intervention

• Change in Time Up and Go test (TUG)

  Baseline, and after 16-weeks of intervention

• Change in 30 seconds Sit-to-stand (STS)

  Baseline, and after 16-weeks of intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group will receive the 16-week Baduanjin exercise intervention.

Other: Baduanjin exercise program

Control Group

NO INTERVENTION

Control group will not receive the exercise intervention, but they will attend four education classes about managing their health status.

Interventions

Baduanjin exercise program OTHER

Baduanjin (BDJ), also known as Eight-Section Brocades, is one of the forms of traditional Chinese Qigong exercises, characterized by symmetrical physical posture, movements, mindfulness, and breathing. Its primary focus is on the release of 'Qi' or internal body energy with the intent of improving health outcomes. BDJ encompasses eight simple movements involving combinations of postures, meditation, slow relaxing movements, and breathing exercises. It is a low intensity exercise, which have been found to improve range of motion, strength and general health. The simplicity and low intensity level is ideal for older adults to practice at home using instructional videos.

Intervention Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geriatric Education and Research Institute: lead
• Tsao Foundation: collaborator

Study Sites (1)

Yong-en Care Centre

Singapore, Singapore

Location

Related Publications (2)

• 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.

  PMID: 32699644 BACKGROUND

• Tou NX, Goh SF, Harding S, Tsao MA, Ng TP, Wee SL. Effectiveness of community-based Baduanjin exercise intervention for older adults with varying frailty status: a randomized controlled trial. Eur Rev Aging Phys Act. 2024 Oct 10;21(1):28. doi: 10.1186/s11556-024-00363-6.

  PMID: 39390362 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 16, 2020
• Study Start: April 30, 2021
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)