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

January 31, 2024 updated by: Geriatric Education and Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Yong-en Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Intervention group will receive the 16-week Baduanjin exercise intervention.
Other: Baduanjin exercise program
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.
No Intervention: Control Group
Control group will not receive the exercise intervention, but they will attend four education classes about managing their health status.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Physiological Profile Assessment. (PPA - Short Form)
Time Frame: Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention
Change in Hand Grip Strength
Time Frame: Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention
Change in 6-meter Fast Gait Speed Test
Time Frame: Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention
Change in Time Up and Go test (TUG)
Time Frame: Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention
Change in 30 seconds Sit-to-stand (STS)
Time Frame: Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention
Change in Frailty Score
Time Frame: Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention
Change in EuroQol-Five Dimensions (EQ-5D)
Time Frame: Baseline, and after 16-weeks of intervention
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.
Baseline, and after 16-weeks of intervention
Change in Geriatric Depression Scale (GDS)
Time Frame: Baseline, and after 16-weeks of intervention
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".
Baseline, and after 16-weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Geriatric Education and Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tsao Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCMG BDJ RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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