A Multimodal Exercise Program in Musculoskeletal System of the Community Elderly

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.

Study Overview

• Status: Completed
• Conditions: Elderly Exercise
• Intervention / Treatment: Other: multimodal exercise program

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Yu Hsuan Tseng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	measure gait speed as usual	change between two time points (baseline, 3 months later)
Gait speed	measure gait speed as usual	change between two time points (baseline, 6 months later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Measure by body composition study	change between two time points (baseline, 6 months later)
Level (mild, moderate, maximal) of daily activity	Use pedometer	change between two time points (baseline, 3 months later)
Level (mild, moderate, maximal) of daily activity	Use pedometer	change between two time points (baseline, 6 months later)
Zipper test	use for evaluation of flexibility	change between two time points (baseline, 3 months later)
Zipper test	use for evaluation of flexibility	change between two time points (baseline, 6 months later)
Sit and reach test	use for evaluation of flexibility	change between two time points (baseline, 3 months later)
Sit and reach test	use for evaluation of flexibility	change between two time points (baseline, 6 months later)
Biceps strength	Times of biceps curls within 30 seconds	change between two time points (baseline, 3 months later)
Biceps strength	Times of biceps curls within 30 seconds	change between two time points (baseline, 6 months later)
Strength of lower limbs	Times of sit and stand test within 30 seconds	change between two time points (baseline, 3 months later)
Strength of lower limbs	Times of sit and stand test within 30 seconds	change between two time points (baseline, 6 months later)
One leg stand test	measure the duration when standing on one leg	change between two time points (baseline, 3 months later)
One leg stand test	measure the duration when standing on one leg	change between two time points (baseline, 6 months later)
Timed up and go test	measure the time spent for standing up, walking for 3 meter, turning around, going back and sitting down	change between two time points (baseline, 3 months later)
Timed up and go test	measure the time spent for standing up, walking for 3 meter, turning around, going back and sitting down	change between two time points (baseline, 6 months later)
Endurance	6 minutes walking test	change between two time points (baseline, 3 months later)
Endurance	6 minutes walking test	change between two time points (baseline, 6 months later)
Range of motion of knee	measure by goniometer	change between two time points (baseline, 3 months later)
Range of motion of knee	measure by goniometer	change between two time points (baseline, 6 months later)
Pain, stiffness, physical function of knee	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.	change between two time points (baseline, 3 months later)
Pain, stiffness, physical function of knee	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.	change between two time points (baseline, 6 months later)
Grip strength	measure grip strength by Camry EH101	change between two time (baseline, 3 months later)
Grip strength	measure grip strength by Camry EH101	change between two time (baseline, 6 months later)

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (ACTUAL): September 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2001800707B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No