NCT03258827

Brief Summary

As the proportion of older adults increases, elderly-related issues attract more attention. Sarcopenia is one of the popular elderly-related issues. Sarcopenia may induce decreased muscle strength, poor physical activity, even disability and increase rate of hospitalization and mortality. Therefore, we want to figure out the management for decreasing prevalence of sarcopenia in older adults. This trial is planned to perform during 2017/08/01\~2017/12/31. We plan to enroll 60 elderlies who are sarcopenia. These patient will be divided into 2 group randomize. Experimental group will be received a set of exercise, composed by warm-up, strengthening training with a towel, cold-down, 60 minutes per time, 3 times per week. Control group will be suggested home-based walking activity. We will evaluate the patient's functional performance three times, before training, after training, post-training for three months, respectively. These results will be analyzed by repeated measure ANOVA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

July 18, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

July 18, 2017

Last Update Submit

July 16, 2018

Conditions

Keywords

elderlysarcopeniastrengthening exercise

Outcome Measures

Primary Outcomes (9)

  • Fat mass

    Dual-energy X-ray absorptiometry is used for measuring fat mass.

    Baseline

  • Fat-free mass

    Dual-energy X-ray absorptiometry is used for measuring fat-free mass.

    Baseline

  • Bone mineral density

    Dual-energy X-ray absorptiometry is used for measuring bone mineral density.

    Baseline

  • Maximal grip strength

    Handgrip dynamometer is used for measuring maximal grip strength.

    Baseline

  • Walking speed

    Participants are asked to walk at a comfortable speed to perform 10 meter walk test.

    Baseline

  • Timed up and go test

    At first, the participant sits down. Then the participant would be asked to stand up, walk straight for 3 meters, turn around, go back to the chair and sit down. The duration of whole test would be measured.

    Baseline

  • Times of stand-up and sit-down within 30 seconds

    The participant is asked to cross arm before the chest. The investigator would record the times of stand-up and sit-down within 30 seconds.

    Baseline

  • 6 minutes walking test

    At first, the participant sits down for a rest for 10 minutes. The participant would be asked to walk as longer distance as the participant can within 6 minutes.

    Baseline

  • Berg balance test

    The investigator record scores of 14 items involved in Berg balance test for measuring balance of the old adults.

    Baseline

Secondary Outcomes (18)

  • Fat mass

    Change between baseline and 3 month after training

  • Fat mass

    Change between baseline and 6 month after training

  • Fat-free mass

    Change between baseline and 3 month after training

  • Fat-free mass

    Change between baseline and 6 month after training

  • Bone mineral density

    Change between baseline and 3 month after training

  • +13 more secondary outcomes

Study Arms (2)

Exercise with a towel

EXPERIMENTAL

There are 30 old adults in this group who receives exercise program with a towel.

Procedure: Exercise with a towel

Home-based exercise

PLACEBO COMPARATOR

There are 30 old adults in this group who is suggested a home-based program focuses on walking activity at fast speed.

Procedure: Home-based exercise

Interventions

Exercise program composes with warm-up, strengthening exercise, cold-down, 60 minutes/time, 3 times/week. A towel is an important tool for exercise. Total duration of the program is 3 months.

Also known as: Home-based exercise
Exercise with a towel

Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times. The total duration is 3 months.

Home-based exercise

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age above 65 y/o
  • low muscle mass (male\<7.0 kg/m2, female\<5.4kg/m2, tested by Dual energy X-ray Absorptiometry)
  • with or without low grip strength (male\< 26 kg, female \<18 kg)
  • with or without low walk speed (≤ 0.8 m/s).

You may not qualify if:

  • cognitive impairment or can't follow order appropriately
  • elderlies with medical problems that they can't perform the exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wujia Senior Citizens activity Center of Kaohsiung City Government

Kaohsiung City, 830, Taiwan

Location

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 Officials

  • Shui Tseng

    Chang Gung Medical Foundation Institutional Review Board

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assistant who doesn't know the group which patients belong to will evaluate the functional performance of the patients three times, such as before training, after training, post-training 3 months.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We randomize these 60 older adults into 2 groups (experimental group and control group) and there are 30 older adults in each group. Those older adults are age above 65 year-old, have lower grip strength and slower walking speed. Experimental group receive this exercise program training, 60 minutes/time, 3 times/week, total duration: 3 months. Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times, would be assigned for Control group. Total duration is 3 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

August 23, 2017

Study Start

September 1, 2017

Primary Completion

April 30, 2018

Study Completion

June 30, 2018

Last Updated

July 18, 2018

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations