Effects of Exercise Training on Functional Physical Fitness, Balance and Walking in the Community-dwelling Older Adults

• ClinicalTrials.gov Identifier: NCT04812587
• Recruitment Status: Completed
• First Posted: March 23, 2021
• Last Update Posted: April 13, 2021
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Information provided by (Responsible Party): Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Exercise	Behavioral: exercise intervention program	Not Applicable

Detailed Description:

1. Written informed consent must be obtained before any study specific procedures are undertaken.

2. The process of the experiment (brief describe)

1. 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.
2. 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.
3. 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.
4. After 12 weeks group exercise, the experimental group will receive the second measurements.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effects of Exercise Training on Functional Physical Fitness, Balance and Walking in the Community-dwelling Older Adults
• Actual Study Start Date: January 12, 2018
• Actual Primary Completion Date: September 6, 2019
• Actual Study Completion Date: September 6, 2019

Arms and Interventions

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.	Behavioral: exercise intervention program; 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.

Outcome Measures

Primary Outcome Measures :

1. 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)
2. 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

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 81 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Taiwan

Li-Jiun Liaw

Kaohsiung City, Sanmin Dist, Taiwan, 80708

Sponsors and Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

• Study Director: Li-Jiun Liaw; Kaohsiung Medical University Department of Physical Therapy Associate Professor

More Information

• Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04812587
• Other Study ID Numbers: KMUHIRB-F(I)-20180002
• First Posted: March 23, 2021
• Last Update Posted: April 13, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Currently in the submission stage ,and then share with other researchers after publication

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No