FrailtyNCT04438876
The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore
A study testing Functional Power Training in people with Frailty and Muscle Weakness, run by Geriatric Education and Research Institute at 1 site in Singapore.
Trial summary
To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail and frail community-dwelling older adults in Singapore for the management of physical frailty. Read more about this study
- Who is it for?
- Ages 55 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty, Muscle Weakness
- What is being tested?
- Functional Power Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Mar 2019to 31 Dec 2020
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 55 years and above
- low muscle strength - handgrip strength less than 26kg for men and 18kg for women
- ambulate without human assistance
- able to understand basic instructions
Who cannot join
- currently enrolled in another study
- acute musculoskeletal injury
- unable to participate in the full duration of the study
- unwilling to participate if not assigned to the intervention group
- deemed not suitable to participate in exercise by a medical doctor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore: A Randomised Controlled Trial
To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail and frail community-dwelling older adults in Singapore for the management of physical frailty. The proposed study will provide information on the benefits of FPT on physical performances of older adults and help to shape future exercise recommendations to slow or reverse the onset and severity of physical frailty.
- Conditions
- Frailty, Muscle Weakness
- Being tested
- Functional Power Training, Usual care
- Medical subject headings
- Frailty, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Power TrainingOther
The exercise intervention encompassed high-velocity movement, balance, and mobility exercises with the use of body weight and resistance bands as resistance. Participants were instructed to move rapidly during the concentric phase and slowly during the eccentric phase when performing the dynamic exercises.
Usual careOther
Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.
| Study group | Role | What they receive |
|---|---|---|
| Function power training | Experimental | 12-week structured FPT program, conducted by a certified trainer from a community service provider. Sessions were held twice weekly at the respective community senior activity centers, each lasting 60 minutes in duration. Receives: Other: Functional Power Training |
| Usual care | Active comparator | Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Frail status at 12 and 24 weeks
Cardiovascular Health Study (CHS) Frailty status which characterizes frailty based on five components: unintentional weight loss, weakness, slowness, exhaustion and low physical activity. 1 point for each category. Robust: 0 point, Pre-Frail: 1-2 points , Frail: 3-5 points.
Measured: baseline, 12 weeks, 24 weeks
Change of hand grip strength at 12 and 24 weeks
Hand grip strength (kg)
Measured: baseline, 12 weeks, 24 weeks
Change of knee extensor strength at 12 and 24 weeks
Knee extensor strength (kg)
Measured: baseline, 12 weeks, 24 weeks
Change of Timed up and go (TUG) at 12 and 24 weeks
Timed up and go (TUG) (seconds)
Measured: baseline, 12 weeks, 24 weeks
Change of SPPB at 12 and 24 weeks
Short Physical Performance Battery (SPPB) consist of:
- Balance test
- Gait speed
- Chair stand test
Measured: baseline, 12 weeks, 24 weeks
Secondary outcomes (1)
Exercise adherence
Exercise journals
Measured: baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start14 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geriatric Education and Research Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shiou-Liang Wee, PhD, Principal investigator, Geriatric Education & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438876
- Sponsor's protocol ID
- GERI1618
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tou NX, Wee SL, Seah WT, Ng DHM, Pang BWJ, Lau LK, Ng TP. Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study. Prev Sci. 2021 Nov;22(8):1048-1059. doi: 10.1007/s11121-021-01221-y. Epub 2021 Mar 19.
PubMed 33742266
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04438876
- Acronym / sponsor ID
- GERI1618
- Conditions
- Frailty, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Geriatric Education and Research InstituteOther government
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Jun 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.
To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail and frail community-dwelling older adults in Singapore for the management of physical frailty. The proposed study will provide information on the benefits of FPT on physical performances of older adults and help to shape future exercise recommendations to slow or reverse the onset and severity of physical frailty.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Function power training | Experimental | Other: Functional Power Training12-week structured FPT program, conducted by a certified trainer from a community service provider. Sessions were held twice weekly at the respective community senior activity centers, each lasting 60 minutes in duration. |
| Usual care | Active comparator | Other: Usual careParticipants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine. |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 55 years and above
- low muscle strength - handgrip strength less than 26kg for men and 18kg for women
- ambulate without human assistance
- able to understand basic instructions
Key exclusion criteria (5 listed)
- currently enrolled in another study
- acute musculoskeletal injury
- unable to participate in the full duration of the study
- unwilling to participate if not assigned to the intervention group
- deemed not suitable to participate in exercise by a medical doctor
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 |
|---|---|---|
| Functional Power TrainingThe exercise intervention encompassed high-velocity movement, balance, and mobility exercises with the use of body weight and resistance bands as resistance. Participants were instructed to move rapidly during the concentric phase and slowly during the eccentric phase when performing the dynamic exercises. | Other | Function power training |
| Usual careParticipants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine. | Other | Usual care |
Primary outcome
Change of Frail status at 12 and 24 weeks
Time frame: baseline, 12 weeks, 24 weeks
Cardiovascular Health Study (CHS) Frailty status which characterizes frailty based on five components: unintentional weight loss, weakness, slowness, exhaustion and low physical activity. 1 point for each category. Robust: 0 point, Pre-Frail: 1-2 points , Frail: 3-5 points.
Change of hand grip strength at 12 and 24 weeks
Time frame: baseline, 12 weeks, 24 weeks
Hand grip strength (kg)
Change of knee extensor strength at 12 and 24 weeks
Time frame: baseline, 12 weeks, 24 weeks
Knee extensor strength (kg)
Change of Timed up and go (TUG) at 12 and 24 weeks
Time frame: baseline, 12 weeks, 24 weeks
Timed up and go (TUG) (seconds)
Change of SPPB at 12 and 24 weeks
Time frame: baseline, 12 weeks, 24 weeks
Short Physical Performance Battery (SPPB) consist of: 1. Balance test 2. Gait speed 3. Chair stand test
1 secondary outcome
Exercise adherence
Time frame: baseline, 12 weeks, 24 weeks
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 9 Feb 2021.
- Derived from this study: PubMed 33742266Tou NX, Wee SL, Seah WT, Ng DHM, Pang BWJ, Lau LK, Ng TP. Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study. Prev Sci. 2021 Nov;22(8):1048-1059. doi: 10.1007/s11121-021-01221-y. Epub 2021 Mar 19.
- 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.
Shiou-Liang Wee, PhD principal investigator
Geriatric Education & Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Power Training in people with Frailty and Muscle Weakness, 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 5 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 9 Feb 2021. 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 of Frail status at 12 and 24 weeks (time frame: baseline, 12 weeks, 24 weeks). The study lists 5 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 NCT04438876, 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 9 Feb 2021.