NCT04438876

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 9, 2021

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

June 15, 2020

Last Update Submit

February 8, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    baseline, 12 weeks, 24 weeks

  • Change of hand grip strength at 12 and 24 weeks

    Hand grip strength (kg)

    baseline, 12 weeks, 24 weeks

  • Change of knee extensor strength at 12 and 24 weeks

    Knee extensor strength (kg)

    baseline, 12 weeks, 24 weeks

  • Change of Timed up and go (TUG) at 12 and 24 weeks

    Timed up and go (TUG) (seconds)

    baseline, 12 weeks, 24 weeks

  • Change of SPPB at 12 and 24 weeks

    Short Physical Performance Battery (SPPB) consist of: 1. Balance test 2. Gait speed 3. Chair stand test

    baseline, 12 weeks, 24 weeks

Secondary Outcomes (1)

  • Exercise adherence

    baseline, 12 weeks, 24 weeks

Study Arms (2)

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.

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.

Other: Usual care

Interventions

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.

Function power training

Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.

Usual care

Eligibility Criteria

Age55 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Education & Research Institute

Singapore, Singapore

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

FrailtyMuscle Weakness

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Shiou-Liang Wee, PhD

    Geriatric Education & Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 19, 2020

Study Start

March 14, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 9, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations