Age ProblemNCT04690465
Resistance Training on Elderly Resilience
A study testing Resistance training and Eight-form Yang-style Tai Chi program in people with Age Problem and Healthy Aging, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial summary
Background: There is on one hand sufficient evidence showing strong association between resilience and self-rated successful aging. On the other hand, strength training could contribute the cultivation of resilience among older adults. Read more about this study
- Who is it for?
- Ages 65 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Age Problem, Healthy Aging, Activity, Motor
- What is being tested?
- Resistance training and Eight-form Yang-style Tai Chi program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jan 2021to 30 Dec 2021
- 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 65 to 74 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 to 74 years old;
- capable to walk without assistive device;
- apparently healthy and live independently in communities
Who cannot join
- with cardiovascular or related diseases that prevent from resistance training;
- fail the PAR-Q screening or without physician's advice on readiness of participation in resistance training;
- with substantial experience in practicing resistance training or Tai Chi;
- with high level of resilience.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Hong Kong Baptist University Sports Hall
Hong Kong, Kowloon, 000000
About this study
Official title: Effectiveness of Resistance Training on Resilience in Hong Kong Chinese Older Adults: Study Protocol for a Randomized Controlled Trial
Background: There is on one hand sufficient evidence showing strong association between resilience and self-rated successful aging. On the other hand, strength training could contribute the cultivation of resilience among older adults. Therefore, the current study aims to examine the effectiveness of resistance training on resilience among Chinese older adults in Hong Kong.
Methods: This study will apply a three-group, double blinded (outcome assessors and data analysts), randomized controlled trial (RCT) to examine the effectiveness of the interventions on resilience, functional fitness, and health related quality of life immediately after a 16-week intervention, as well as the residual effects 12 weeks after completion of the interventions.
Discussion: It is expected that resistance training is promising or even superior to aerobic training in the improvement of resilience. Given the limited evidence on the literature, it is urgently needed to explore the effects of resistance training on the improvement of resilience in older adults. Findings of the current study can contribute to the development of effective resistant training programs for the promotion of resilience among older adults.
- Conditions
- Age Problem, Healthy Aging, Activity, Motor
- Being tested
- Resistance training, Eight-form Yang-style Tai Chi program
- Keywords
- Resistance Training, Older Adults, Ageing, Resilience, Psychological Health
- Medical subject headings
- Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Also called Strength training group
Participants will receive a 16-week resistance training program, with 3 times a week (a total of 48 training sessions) and 60 minutes per session intervention, which is adopted from the 12-week resistance training program introduced in the book "Growing Stronger: Strength Training for Older Adults" (Seguin et al., 2002), with minor modifications under the advice of Physical Fitness Association of Hong Kong, China (PFA).
Eight-form Yang-style Tai Chi programBehavioural
Also called Tai Chi Group
The active concurrent control group will receive Eight-form Yang-style Tai Chi program which has been confirmed feasible and will be taught by the qualified coach.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | In the 16 week resistance training, there will be 3 sessions per week, the duration of each session will be 60 minutes, which include 10min of warm-up, 40min of main exercise, and 10min of cool-down. The intensity will be light to somewhat hard (Rating of Perceived Exertion (RPE) 11 to 13; using the Cantonese version of RPE). In resistance training, the weights (resistance) will be from participants' own bodies, dumbbells, and adjustable ankle weights. Receives: Behavioral: Resistance training |
| Eight-form Yang-style Tai Chi program | Active comparator | In Tai Chi, the 16-week program will be divided into cognitive, associated, and automatic stages. The coach will apply a group teaching with individual instruction on specific movements based on participant's needs in skills learning and acquisition. The same training principles of individuality and progression as well as training log-book used in resistance training will also be applied to Tai Chi training program. Receives: Behavioral: Eight-form Yang-style Tai Chi program |
| Non-treatment Concurrent Control | No intervention | Participants in this group will not participate in any specific intervention during the whole study (the 16-week intervention and 12-week follow-up periods), but they will be asked to keep a daily log on their physical activity, medicine used, illness, diet, sleep quality and other health and physical activity related information (e.g., attending healthy eating workshops). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience - The Chinese Version of Resilience Scale
Chinese version of RS (CRS) will be used to measure participants' resilience in the study. The CRS was modified from the Resilience Scale developed by Wagnild and Young with subsequent validation in Chinese older population and confirmed its four-factor structure: equanimity, meaningfulness, ceaseless self-improvement, and self-reliance. It is a 7-point Likert scale from 1 (highly disagree) to 7 (highly agree), with a greater score mirroring higher level of resilience. Three levels are set, with scores of 145 and above indicating moderate to high resilience, scores from 126 to 144 indicating low to moderate levels of resilience, and scores less than 126 indicating low resilience.
Measured: The measure is conducted to examine the change from baseline resilience level at 4 months and at 7 months.
Secondary outcomes (6)
Functional fitness - Senior Fitness Test (SFT): Body Composition
The functional fitness (FF) of participants will be measured using the Senior Fitness Test (SFT) battery. The SFT is a widely used measurement for functional fitness of older adults in the ageing and physical activity area. Within the SFT, the body mass index (BMI) will be used to examine the body composition of the participants.
Measured: The measure is conducted to examine the change from baseline body composition at 4 months and at 7 months.
Functional fitness - Senior Fitness Test (SFT): Muscle Strength
The functional fitness (FF) of participants will be measured using the Senior Fitness Test (SFT) battery. The SFT is a widely used measurement for functional fitness of older adults in the ageing and physical activity area. Within the SFT, the 30s chair stand test and 30s arm curl test will be used to examine the muscle strength of the participants.
Measured: The measure is conducted to examine the change from baseline Muscle Strength and Endurance level at 4 months and at 7 months.
Functional fitness - Senior Fitness Test (SFT): Aerobic Endurance
The functional fitness (FF) of participants will be measured using the Senior Fitness Test (SFT) battery. The SFT is a widely used measurement for functional fitness of older adults in the ageing and physical activity area. Within the SFT, 2min step test will be used to examine the aerobic endurance of the participants.
Measured: The measure is conducted to examine the change from baseline aerobic endurance level at 4 months and at 7 months.
Functional fitness - Senior Fitness Test (SFT): Flexibility
The functional fitness (FF) of participants will be measured using the Senior Fitness Test (SFT) battery. The SFT is a widely used measurement for functional fitness of older adults in the ageing and physical activity area. Within the SFT, chair sit-and-reach test and back scratch test will be used to examine the flexibility of the participants.
Measured: The measure is conducted to examine the change from baseline flexibility at 4 months and at 7 months.
Functional fitness - Senior Fitness Test (SFT): Motor Ability and Balance
The functional fitness (FF) of participants will be measured using the Senior Fitness Test (SFT) battery. The SFT is a widely used measurement for functional fitness of older adults in the ageing and physical activity area. Within the SFT, 8ft up-and-go test will be used to examine the motor ability and balance of the participants.
Measured: The measure is conducted to examine the change from baseline motor ability and balance at 4 months and at 7 months.
Health related quality of life - The Chinese Version of Short Form-36 (C-SF-36)
The SF-36 consists of 36 items covering two dimensions-physical health (physical functioning, role limitations due to physical problems, role limitations due to emotional problems, and social functioning) and mental health (mental health, vitality, body pain, and general health perception).
Measured: The measure is conducted to examine the change from baseline quality of life level at 4 months and at 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start30 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age ProblemStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Qualified participants who have signed a consent letter will be randomly assigned into three groups by a draw of lots, in a ratio of 1:1:1. The three groups will be 1) Intervention group: Resistance training (n = 40); 2) Active concurrent control group: Eight-form Yang-style Tai Chi program (n = 40); and 3) Non-treatment control group (n = 40).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Nanjing Normal University
- Responsible party
- Principal investigator, Chung Pak Kwong, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690465
- Sponsor's protocol ID
- GRF Ref: 12610119
- Status last verified
- Mar 2022
- First submitted
- 23 Dec 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chung PK, Zhang CQ, Zhao Y, Wong MYC, Hu C. Effectiveness of resistance training on resilience in Hong Kong Chinese older adults: study protocol for a randomized controlled trial. BMC Geriatr. 2021 Apr 15;21(1):250. doi: 10.1186/s12877-021-02197-8.
PubMed 33858336
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Resistance Training on Resilience in Hong Kong Chinese Older Adults: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04690465
- Acronym / sponsor ID
- GRF Ref: 12610119
- Conditions
- Age Problem, Healthy Aging, Activity, Motor
- Keywords
- Resistance Training, Older Adults, Ageing, Resilience, Psychological Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Nanjing Normal University
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 30 Dec 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.
Background: There is on one hand sufficient evidence showing strong association between resilience and self-rated successful aging. On the other hand, strength training could contribute the cultivation of resilience among older adults. Therefore, the current study aims to examine the effectiveness of resistance training on resilience among Chinese older adults in Hong Kong.
Methods: This study will apply a three-group, double blinded (outcome assessors and data analysts), randomized controlled trial (RCT) to examine the effectiveness of the interventions on resilience, functional fitness, and health related quality of life immediately after a 16-week intervention, as well as the residual effects 12 weeks after completion of the interventions.
Discussion: It is expected that resistance training is promising or even superior to aerobic training in the improvement of resilience. Given the limited evidence on the literature, it is urgently needed to explore the effects of resistance training on the improvement of resilience in older adults. Findings of the current study can contribute to the development of effective resistant training programs for the promotion of resilience among older adults.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Qualified participants who have signed a consent letter will be randomly assigned into three groups by a draw of lots, in a ratio of 1:1:1. The three groups will be 1) Intervention group: Resistance training (n = 40); 2) Active concurrent control group: Eight-form Yang-style Tai Chi program (n = 40); and 3) Non-treatment control group (n = 40).
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Behavioral: Resistance trainingIn the 16 week resistance training, there will be 3 sessions per week, the duration of each session will be 60 minutes, which include 10min of warm-up, 40min of main exercise, and 10min of cool-down. The intensity will be light to somewhat hard (Rating of Perceived Exertion (RPE) 11 to 13; using the Cantonese version of RPE). In resistance training, the weights (resistance) will be from participants' own bodies, dumbbells, and adjustable ankle weights. |
| Eight-form Yang-style Tai Chi program | Active comparator | Behavioral: Eight-form Yang-style Tai Chi programIn Tai Chi, the 16-week program will be divided into cognitive, associated, and automatic stages. The coach will apply a group teaching with individual instruction on specific movements based on participant's needs in skills learning and acquisition. The same training principles of individuality and progression as well as training log-book used in resistance training will also be applied to Tai Chi training program. |
| Non-treatment Concurrent Control | No intervention | –Participants in this group will not participate in any specific intervention during the whole study (the 16-week intervention and 12-week follow-up periods), but they will be asked to keep a daily log on their physical activity, medicine used, illness, diet, sleep quality and other health and physical activity related information (e.g., attending healthy eating workshops). |
Who may qualify
- Ages
- 65 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 to 74 years old;
- capable to walk without assistive device;
- apparently healthy and live independently in communities
Key exclusion criteria (4 listed)
- with cardiovascular or related diseases that prevent from resistance training;
- fail the PAR-Q screening or without physician's advice on readiness of participation in resistance training;
- with substantial experience in practicing resistance training or Tai Chi;
- with high level of resilience.
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 |
|---|---|---|
| Resistance trainingAlso: Strength training groupParticipants will receive a 16-week resistance training program, with 3 times a week (a total of 48 training sessions) and 60 minutes per session intervention, which is adopted from the 12-week resistance training program introduced in the book "Growing Stronger: Strength Training for Older Adults" (Seguin et al., 2002), with minor modifications under the advice of Physical Fitness Association of Hong Kong, China (PFA). | Behavioural | Resistance training |
| Eight-form Yang-style Tai Chi programAlso: Tai Chi GroupThe active concurrent control group will receive Eight-form Yang-style Tai Chi program which has been confirmed feasible and will be taught by the qualified coach. | Behavioural | Eight-form Yang-style Tai Chi program |
Primary outcome
Resilience - The Chinese Version of Resilience Scale
Time frame: The measure is conducted to examine the change from baseline resilience level at 4 months and at 7 months.
Chinese version of RS (CRS) will be used to measure participants' resilience in the study. The CRS was modified from the Resilience Scale developed by Wagnild and Young with subsequent validation in Chinese older population and confirmed its four-factor structure: equanimity, meaningfulness, ceaseless self-improvement, and self-reliance. It is a 7-point Likert scale from 1 (highly disagree) to 7 (highly agree), with a greater score mirroring higher level of resilience. Three levels are set, with scores of 145 and above indicating moderate to high resilience, scores from 126 to 144 indicating low to moderate levels of resilience, and scores less than 126 indicating low resilience.
6 secondary outcomes
Functional fitness - Senior Fitness Test (SFT): Body Composition
Time frame: The measure is conducted to examine the change from baseline body composition at 4 months and at 7 months.
Functional fitness - Senior Fitness Test (SFT): Muscle Strength
Time frame: The measure is conducted to examine the change from baseline Muscle Strength and Endurance level at 4 months and at 7 months.
Functional fitness - Senior Fitness Test (SFT): Aerobic Endurance
Time frame: The measure is conducted to examine the change from baseline aerobic endurance level at 4 months and at 7 months.
Functional fitness - Senior Fitness Test (SFT): Flexibility
Time frame: The measure is conducted to examine the change from baseline flexibility at 4 months and at 7 months.
Functional fitness - Senior Fitness Test (SFT): Motor Ability and Balance
Time frame: The measure is conducted to examine the change from baseline motor ability and balance at 4 months and at 7 months.
Health related quality of life - The Chinese Version of Short Form-36 (C-SF-36)
Time frame: The measure is conducted to examine the change from baseline quality of life level at 4 months and at 7 months.
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 31 Mar 2022.
- Derived from this study: PubMed 33858336Chung PK, Zhang CQ, Zhao Y, Wong MYC, Hu C. Effectiveness of resistance training on resilience in Hong Kong Chinese older adults: study protocol for a randomized controlled trial. BMC Geriatr. 2021 Apr 15;21(1):250. doi: 10.1186/s12877-021-02197-8.
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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 Resistance training and Eight-form Yang-style Tai Chi program in people with Age Problem and Healthy Aging, run by Hong Kong Baptist University at 1 site in Hong Kong.
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 3 inclusion and 4 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 31 Mar 2022. 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 Hong Kong. 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?
Resilience - The Chinese Version of Resilience Scale (time frame: The measure is conducted to examine the change from baseline resilience level at 4 months and at 7 months.). 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 NCT04690465, which also lists 1 linked publication.
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 31 Mar 2022.