A Multimodal Exercise Program in Musculoskeletal System of the Community Elderly

August 5, 2019 updated by: Chang Gung Memorial Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • Kaohsiung, Taiwan
        • Yu Hsuan Tseng

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gait speed
Time Frame: change between two time points (baseline, 3 months later)
measure gait speed as usual
change between two time points (baseline, 3 months later)
Gait speed
Time Frame: change between two time points (baseline, 6 months later)
measure gait speed as usual
change between two time points (baseline, 6 months later)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: change between two time points (baseline, 6 months later)
Measure by body composition study
change between two time points (baseline, 6 months later)
Level (mild, moderate, maximal) of daily activity
Time Frame: change between two time points (baseline, 3 months later)
Use pedometer
change between two time points (baseline, 3 months later)
Level (mild, moderate, maximal) of daily activity
Time Frame: change between two time points (baseline, 6 months later)
Use pedometer
change between two time points (baseline, 6 months later)
Zipper test
Time Frame: change between two time points (baseline, 3 months later)
use for evaluation of flexibility
change between two time points (baseline, 3 months later)
Zipper test
Time Frame: change between two time points (baseline, 6 months later)
use for evaluation of flexibility
change between two time points (baseline, 6 months later)
Sit and reach test
Time Frame: change between two time points (baseline, 3 months later)
use for evaluation of flexibility
change between two time points (baseline, 3 months later)
Sit and reach test
Time Frame: change between two time points (baseline, 6 months later)
use for evaluation of flexibility
change between two time points (baseline, 6 months later)
Biceps strength
Time Frame: change between two time points (baseline, 3 months later)
Times of biceps curls within 30 seconds
change between two time points (baseline, 3 months later)
Biceps strength
Time Frame: change between two time points (baseline, 6 months later)
Times of biceps curls within 30 seconds
change between two time points (baseline, 6 months later)
Strength of lower limbs
Time Frame: change between two time points (baseline, 3 months later)
Times of sit and stand test within 30 seconds
change between two time points (baseline, 3 months later)
Strength of lower limbs
Time Frame: change between two time points (baseline, 6 months later)
Times of sit and stand test within 30 seconds
change between two time points (baseline, 6 months later)
One leg stand test
Time Frame: change between two time points (baseline, 3 months later)
measure the duration when standing on one leg
change between two time points (baseline, 3 months later)
One leg stand test
Time Frame: change between two time points (baseline, 6 months later)
measure the duration when standing on one leg
change between two time points (baseline, 6 months later)
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
change between two time points (baseline, 3 months later)
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
change between two time points (baseline, 6 months later)
Endurance
Time Frame: change between two time points (baseline, 3 months later)
6 minutes walking test
change between two time points (baseline, 3 months later)
Endurance
Time Frame: change between two time points (baseline, 6 months later)
6 minutes walking test
change between two time points (baseline, 6 months later)
Range of motion of knee
Time Frame: change between two time points (baseline, 3 months later)
measure by goniometer
change between two time points (baseline, 3 months later)
Range of motion of knee
Time Frame: change between two time points (baseline, 6 months later)
measure by goniometer
change between two time points (baseline, 6 months later)
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.
change between two time points (baseline, 3 months later)
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.
change between two time points (baseline, 6 months later)
Grip strength
Time Frame: change between two time (baseline, 3 months later)
measure grip strength by Camry EH101
change between two time (baseline, 3 months later)
Grip strength
Time Frame: change between two time (baseline, 6 months later)
measure grip strength by Camry EH101
change between two time (baseline, 6 months later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

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