NCT03607136

Brief Summary

This study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. Half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

July 5, 2018

Last Update Submit

July 23, 2018

Conditions

Keywords

early detectionhealth promotioncommunity-dwellingelderly

Outcome Measures

Primary Outcomes (2)

  • Walking speed

    Participants are asked to walk along a 14 m hallway. The time taken to the middle 10 m is recorded to calculate walking speed (m/s).

    Change from baseline at 12 weeks

  • Muscle strength

    Muscle strength is assessed using hand-hold Dynamometers

    Change from baseline at 12 weeks

Secondary Outcomes (5)

  • Timed up and go test

    Change from baseline at 12 weeks

  • Walking endurance

    Change from baseline at 12 weeks

  • Sit-to-stand test

    Change from baseline at 12 weeks

  • Berg balance scale

    Change from baseline at 12 weeks

  • Gait kinematics

    Change from baseline at 12 weeks

Study Arms (2)

exercise training

EXPERIMENTAL

Participants in the exercise training group received a 12-week exercise training.

Other: exercise training

control

NO INTERVENTION

Participants in the control group did not receive any specific training programs instead of maintaining their usual activities of daily living.

Interventions

Aerobic exercises, strengthening exercises, flexibility training for 60min, twice a week for 12 weeks

exercise training

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age greater than 50 years
  • able to follow simple instructions
  • willing to participate and sign consent form

You may not qualify if:

  • unstable angina or epilepsy
  • severe visual deficits
  • cognitive dysfunction
  • other musculoskeletal conditions that will limit mobility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 31, 2018

Study Start

August 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

July 31, 2018

Record last verified: 2018-07