Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multimodal Exercise Program in Musculoskeletal System of the Community Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03668886
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
The number of elderly has been increasing in recent decades. Current studies focused on the risk factors of poor physical performance, poor daily activity performance, and even disability in the elderly. We planned to evaluate the physical performance of elderly dwelling in the community and designed a multimodal exercise program which can improve physical performance, prevent disability and promote quality of life.

Condition or disease Intervention/treatment Phase
Elderly Exercise Other: multimodal exercise program Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: intervention group: receive multimodal exercise program for half year control group: participate community activity
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multimodal Exercise Program in Musculoskeletal System of the Community Elderly
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: multimodal exercise program
Elderly in this group will receive multimodal exercise program. The duration of exercise is 60 minutes and frequency is 2 times/week.
Other: multimodal exercise program
warm-up, strengthening exercise, aerobic exercise, cool-down

No Intervention: Control group
Elderly in this group will continue to attend community activity as usual. The activity includes active activity is 60 minutes and frequency is 2 times/week.



Primary Outcome Measures :
  1. Gait speed [ Time Frame: change between two time points (baseline, 3 months later) ]
    measure gait speed as usual

  2. Gait speed [ Time Frame: change between two time points (baseline, 6 months later) ]
    measure gait speed as usual


Secondary Outcome Measures :
  1. Muscle mass [ Time Frame: change between two time points (baseline, 6 months later) ]
    Measure by body composition study

  2. Level (mild, moderate, maximal) of daily activity [ Time Frame: change between two time points (baseline, 3 months later) ]
    Use pedometer

  3. Level (mild, moderate, maximal) of daily activity [ Time Frame: change between two time points (baseline, 6 months later) ]
    Use pedometer

  4. Zipper test [ Time Frame: change between two time points (baseline, 3 months later) ]
    use for evaluation of flexibility

  5. Zipper test [ Time Frame: change between two time points (baseline, 6 months later) ]
    use for evaluation of flexibility

  6. Sit and reach test [ Time Frame: change between two time points (baseline, 3 months later) ]
    use for evaluation of flexibility

  7. Sit and reach test [ Time Frame: change between two time points (baseline, 6 months later) ]
    use for evaluation of flexibility

  8. Biceps strength [ Time Frame: change between two time points (baseline, 3 months later) ]
    Times of biceps curls within 30 seconds

  9. Biceps strength [ Time Frame: change between two time points (baseline, 6 months later) ]
    Times of biceps curls within 30 seconds

  10. Strength of lower limbs [ Time Frame: change between two time points (baseline, 3 months later) ]
    Times of sit and stand test within 30 seconds

  11. Strength of lower limbs [ Time Frame: change between two time points (baseline, 6 months later) ]
    Times of sit and stand test within 30 seconds

  12. One leg stand test [ Time Frame: change between two time points (baseline, 3 months later) ]
    measure the duration when standing on one leg

  13. One leg stand test [ Time Frame: change between two time points (baseline, 6 months later) ]
    measure the duration when standing on one leg

  14. Timed up and go test [ Time Frame: change between two time points (baseline, 3 months later) ]
    measure the time spent for standing up, walking for 3 meter, turning around, going back and sitting down

  15. Timed up and go test [ Time Frame: change between two time points (baseline, 6 months later) ]
    measure the time spent for standing up, walking for 3 meter, turning around, going back and sitting down

  16. Endurance [ Time Frame: change between two time points (baseline, 3 months later) ]
    6 minutes walking test

  17. Endurance [ Time Frame: change between two time points (baseline, 6 months later) ]
    6 minutes walking test

  18. Range of motion of knee [ Time Frame: change between two time points (baseline, 3 months later) ]
    measure by goniometer

  19. Range of motion of knee [ Time Frame: change between two time points (baseline, 6 months later) ]
    measure by goniometer

  20. Pain, stiffness, physical function of knee [ Time Frame: change between two time points (baseline, 3 months later) ]
    WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire is used for evaluation of pain, stiffness, physical function of patients with knee osteoarthritis. It includes 5 questions for pain, 2 questions for stiffness and 17 questions for physical function. The score of every question is from 0 to 4. The larger the number, the discomfort becomes more servere. We use the difference of change between two time points (baseline, 3 months later) to measure the benefit of the exercise.

  21. Pain, stiffness, physical function of knee [ Time Frame: change between two time points (baseline, 6 months later) ]
    WOMAC (Western Ontario and McMaster Universities Arthritis Index) questionnaire is used for evaluation of pain, stiffness, physical function of patients with knee osteoarthritis. It includes 5 questions for pain, 2 questions for stiffness and 17 questions for physical function. The score of every question is from 0 to 4. The larger the number, the discomfort becomes more servere. We use the difference of change between two time points (baseline, 6 months later) to measure the benefit of the exercise.

  22. Grip strength [ Time Frame: change between two time (baseline, 3 months later) ]
    measure grip strength by Camry EH101

  23. Grip strength [ Time Frame: change between two time (baseline, 6 months later) ]
    measure grip strength by Camry EH101



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >= 65 year old

Exclusion Criteria:

  • cognitive impairment and poor understanding for orders
  • the elderly has medical problems that the elderly can't perform exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668886


Locations
Layout table for location information
Taiwan
Yu Hsuan Tseng
Kaohsiung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Study Chair: Shui Tseng Chang Gung Medical Foundation Institutional Review Board

Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03668886     History of Changes
Other Study ID Numbers: 2001800707B0
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No