FrailtyNCT04549103
Effect of Baduanjin on Functional Performance in Pre-Frail/Frail Older Adults
A study testing Baduanjin exercise program in people with Frailty and Frail Elderly Syndrome, run by Geriatric Education and Research Institute at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frailty, Frail Elderly Syndrome
- What is being tested?
- Baduanjin exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Apr 2021to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Community-based Baduanjin (八段锦) on Functional Performance in Pre-Frail/Frail Older Adults: A Randomised Controlled Trial
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
- Being tested
- Baduanjin exercise program
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group will receive the 16-week Baduanjin exercise intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, and after 16-weeks of intervention
Secondary outcomes (8)
Change in Physiological Profile Assessment. (PPA - Short Form)
Physiological Profile Assessment (PPA) is a valid and reliable measure of balance function and fall risk, is feasible for older adults to undertake, and can quantify changes in specific physical components contributing to falls in response to BDJ training. PPA comprises a series of five sensorimotor assessments: edge contrast sensitivity, lower limb proprioception, knee extension strength, hand reaction time, and postural sway. These five components will be weighted to compute a composite PPA fall risk score: high composite PPA scores indicate high risk of falling.
Measured: Baseline, and after 16-weeks of intervention
Change in Hand Grip Strength
Hand-grip dynamometer was found to be a valid tool in clinical and research practice, and is an easy, quick, and inexpensive way of assessing HGS in older adults. Prior to performing the hand-grip strength test, hand dominance is determined by asking participants which hand they use for writing or which hand they would predominantly use when performing a task. HGS is measured in kilograms by taking the average of the two dominant handgrip attempts using a Jamar Plus + Digital Hand Dynamometer.
Measured: Baseline, and after 16-weeks of intervention
Change in 6-meter Fast Gait Speed Test
The purpose of the gait speed test is to measure the participant's fastest speed while walking and mobility. Fast gait speed is determined across a distance of 6 meter, which is marked on the floor with tape. Subjects are allowed to use their usual walking aid. Two trails will be administered, time (in seconds) will be recorded for each trial. The average speed of two trails will be recorded as the fast gait speed.
Measured: Baseline, and after 16-weeks of intervention
Change in Time Up and Go test (TUG)
Time Up and Go test (TUG) is a reliable and valid test for quantifying functional mobility for frail elder person. The participant is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. As the test is quick, and requires no special equipment or training, it is widely used in studies as a physical assessment.
Measured: Baseline, and after 16-weeks of intervention
Change in 30 seconds Sit-to-stand (STS)
Sit-to-stand (STS) test is a commonly used functional performance measure in clinical research and practice. STS performance is influenced by multiple physiological and psychological processes and represents a particular transfer skill, rather than a proxy measure of lower limb strength. In 30 seconds STS, participants will be asked to rise from the chair as fast as possible with their arms fold across their chest and the number of times they are able to perform sit-to-stand successfully within 30 seconds will be recorded. The performance of this test is suggested to be influenced by factors associated with balance, muscle strength, lower extremity endurance, and mobility as well.
Measured: Baseline, and after 16-weeks of intervention
Change in Frailty Score
Frailty score of the participants will be assessed based on the five criteria by Fried in the Cardiovascular Health Study (CHS). The five criteria (modified for this pilot study) include: unintentional weight loss >10 lbs (4.5kg) and/or BMI of <18.5 in the last 6 months measured by self-report, weakness measured by knee extension strength, slowness measured by 6-m gait speed, exhaustion measured by questionnaire (SF-12), and physical inactivity measured by LASA Physical Activity Questionnaire. One-point is assign for the presence of each component, and based on the individual's total score, participants are categorized as frail (3-5 points), pre-frail (1-2 points), and robust (0 point). Reduction in frailty during the study is defined as a transition to a lower frailty category from baseline over 3 months.
Measured: Baseline, and after 16-weeks of intervention
Change in EuroQol-Five Dimensions (EQ-5D)
EQ-5D is one of the most commonly used generic health quality of life (QoL) status measurement, and its good validity and reliability have been reported in various health conditions. In this study, EQ-5D will be used as a standardized instrument for measuring generic health-related QoL.
Measured: Baseline, and after 16-weeks of intervention
Change in Geriatric Depression Scale (GDS)
GDS is a 30-item self-report assessment used to identify depression in the elderly. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
Measured: Baseline, and after 16-weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start30 Apr 2021
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geriatric Education and Research Institute
- Sponsor type
- Other government
- Collaborators
- Tsao Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549103
- Sponsor's protocol ID
- TCMG BDJ RCT
- Status last verified
- Jan 2024
- First submitted
- 24 Aug 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32699644Tou 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.
PubMed 39390362
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Community-based Baduanjin (八段锦) on Functional Performance in Pre-Frail/Frail Older Adults: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04549103
- Acronym / sponsor ID
- TCMG BDJ RCT
- Conditions
- Frailty, Frail Elderly Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Geriatric Education and Research InstituteOther government
- Collaborators
- Tsao Foundation
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Baduanjin exercise programIntervention group will receive the 16-week Baduanjin exercise intervention. |
| Control Group | No intervention | –Control group will not receive the exercise intervention, but they will attend four education classes about managing their health status. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin exercise programBaduanjin (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. | Other | Intervention Group |
Primary outcome
Change in Knee Extension Strength
Time frame: Baseline, and after 16-weeks of intervention
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.
Change in Maastricht Vital Exhaustion Score (MQ)
Time frame: Baseline, and after 16-weeks of intervention
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.
Change in Falls Efficacy Scale-International (FES-I)
Time frame: Baseline, and after 16-weeks of intervention
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.
8 secondary outcomes
Change in Physiological Profile Assessment. (PPA - Short Form)
Time frame: Baseline, and after 16-weeks of intervention
Change in Hand Grip Strength
Time frame: Baseline, and after 16-weeks of intervention
Change in 6-meter Fast Gait Speed Test
Time frame: Baseline, and after 16-weeks of intervention
Change in Time Up and Go test (TUG)
Time frame: Baseline, and after 16-weeks of intervention
Change in 30 seconds Sit-to-stand (STS)
Time frame: Baseline, and after 16-weeks of intervention
Change in Frailty Score
Time frame: Baseline, and after 16-weeks of intervention
Change in EuroQol-Five Dimensions (EQ-5D)
Time frame: Baseline, and after 16-weeks of intervention
Change in Geriatric Depression Scale (GDS)
Time frame: Baseline, and after 16-weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 32699644Liu 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.
- Derived from this study: PubMed 39390362Tou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin exercise program in people with Frailty and Frail Elderly Syndrome, run by Geriatric Education and Research Institute at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Extension Strength (time frame: Baseline, and after 16-weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549103, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.