- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812587
Effects of Exercise Training on Functional Physical Fitness, Balance and Walking in the Community-dwelling Older Adults
April 8, 2021 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
This study aimed to determine whether a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability was designed to improve functional fitness, balance, walking speed in community-dwelling older people.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
1. Written informed consent must be obtained before any study specific procedures are undertaken.
2. The process of the experiment (brief describe)
- The 30 participants of the experimental group will be recruited from the "community eldercare service" activities, and this group will receive a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability. The other 30 community-dwelling older people of the comparison group who have been involved in a other regular exercise style will not receive our exercise intervention. The comparison group only receives 2 times measurement at an interval of 12 weeks.
- Subjects completed medical histories, exercise histories, and information on lifestyles by questionnaire and physical examination before participation in the study to ensure they were free from exclusion criteria. The baseline measurements will be conducted before the exercise intervention.
- The experimental group will receive a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability which involved two 2-hour sessions per week. The exercise program contained aerobic exercises, activities of balance, coordination exercises, strength training, and walking training.
- After 12 weeks group exercise, the experimental group will receive the second measurements.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sanmin Dist
-
Kaohsiung City, Sanmin Dist, Taiwan, 80708
- Li-Jiun Liaw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 81 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Independent in basic daily living activities
- At least one or more given assistance in the instrumental Instrumental Activities of Daily Living (IADL) scale
Exclusion Criteria:
- Diagnosis of neurological disease or heart disease
- Assessment do not suitable resistance exercise training, or cannot perform intense activity by doctor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
The healthy elderly will be were recruited to participate in this study.
All the subjects were independent in basic daily living activities, but at least one or more given assistance in the instrumental IADL assessment (ability to use telephone, shopping, food preparing, housekeeping, laundry, mode of transportation, responsibility for own medications, ability to handle finances).
Their age should be ranged between 65 - 81 years.
|
The experimental group will receive a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability which involved two 2-hour sessions once per week.
|
|
No Intervention: Comparison group
The healthy elderly will be were recruited to participate in this study.
All the subjects were independent in basic daily living activities, but at least one or more given assistance in the instrumental IADL assessment (ability to use telephone, shopping, food preparing, housekeeping, laundry, mode of transportation, responsibility for own medications, ability to handle finances).
Their age should be ranged between 65 - 81 years.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in performance of Physical fitness at 12-week
Time Frame: The assessments will be conducted before, immediately after intervention for the experimental group; two times of these assessments to be at an interval of 12 weeks are conducted for the comparison group
|
Senior Fitness test (30-second Chair Stand, 30-second Arm Curl, 2-minute Step, Chair Sit and Reach and 8 Foot Up-and-Go)
|
The assessments will be conducted before, immediately after intervention for the experimental group; two times of these assessments to be at an interval of 12 weeks are conducted for the comparison group
|
|
Changes in Balance and walking ability at 12-week
Time Frame: The assessments will be conducted before, immediately after intervention for the experimental group; two times of these assessments to be at an interval of 12 weeks are conducted for the comparison group
|
One leg standing, Five-repetition sit-to-stand test, Timed up-and-go test and Walking speed test
|
The assessments will be conducted before, immediately after intervention for the experimental group; two times of these assessments to be at an interval of 12 weeks are conducted for the comparison group
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Li-Jiun Liaw, Kaohsiung Medical University Department of Physical Therapy Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2018
Primary Completion (Actual)
September 6, 2019
Study Completion (Actual)
September 6, 2019
Study Registration Dates
First Submitted
March 8, 2021
First Submitted That Met QC Criteria
March 22, 2021
First Posted (Actual)
March 23, 2021
Study Record Updates
Last Update Posted (Actual)
April 13, 2021
Last Update Submitted That Met QC Criteria
April 8, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- KMUHIRB-F(I)-20180002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Currently in the submission stage ,and then share with other researchers after publication
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.