Elderly ExerciseNCT03668886
A Multimodal Exercise Program in Musculoskeletal System of the Community Elderly
A study testing multimodal exercise program in people with Elderly Exercise, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Exercise
- What is being tested?
- multimodal exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- >= 65 year old
Who cannot join
- cognitive impairment and poor understanding for orders
- the elderly has medical problems that the elderly can't perform exercise
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Elderly Exercise
- Being tested
- multimodal exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal exercise programOther
warm-up, strengthening exercise, aerobic exercise, cool-down
| Study group | Role | What they receive |
|---|---|---|
| multimodal exercise program | Experimental | Elderly in this group will receive multimodal exercise program. The duration of exercise is 60 minutes and frequency is 2 times/week. Receives: Other: multimodal exercise program |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
measure gait speed as usual
Measured: change between two time points (baseline, 3 months later)
Gait speed
measure gait speed as usual
Measured: change between two time points (baseline, 6 months later)
Secondary outcomes (23)
Muscle mass
Measure by body composition study
Measured: change between two time points (baseline, 6 months later)
Level (mild, moderate, maximal) of daily activity
Use pedometer
Measured: change between two time points (baseline, 3 months later)
Level (mild, moderate, maximal) of daily activity
Use pedometer
Measured: change between two time points (baseline, 6 months later)
Zipper test
use for evaluation of flexibility
Measured: change between two time points (baseline, 3 months later)
Zipper test
use for evaluation of flexibility
Measured: change between two time points (baseline, 6 months later)
Sit and reach test
use for evaluation of flexibility
Measured: change between two time points (baseline, 3 months later)
Sit and reach test
use for evaluation of flexibility
Measured: change between two time points (baseline, 6 months later)
Biceps strength
Times of biceps curls within 30 seconds
Measured: change between two time points (baseline, 3 months later)
Biceps strength
Times of biceps curls within 30 seconds
Measured: change between two time points (baseline, 6 months later)
Strength of lower limbs
Times of sit and stand test within 30 seconds
Measured: change between two time points (baseline, 3 months later)
Strength of lower limbs
Times of sit and stand test within 30 seconds
Measured: change between two time points (baseline, 6 months later)
One leg stand test
measure the duration when standing on one leg
Measured: change between two time points (baseline, 3 months later)
One leg stand test
measure the duration when standing on one leg
Measured: 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
Measured: 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
Measured: change between two time points (baseline, 6 months later)
Endurance
6 minutes walking test
Measured: change between two time points (baseline, 3 months later)
Endurance
6 minutes walking test
Measured: change between two time points (baseline, 6 months later)
Range of motion of knee
measure by goniometer
Measured: change between two time points (baseline, 3 months later)
Range of motion of knee
measure by goniometer
Measured: 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.
Measured: 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.
Measured: change between two time points (baseline, 6 months later)
Grip strength
measure grip strength by Camry EH101
Measured: change between two time (baseline, 3 months later)
Grip strength
measure grip strength by Camry EH101
Measured: change between two time (baseline, 6 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Sep 2018
- Primary completion30 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly ExerciseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- intervention group: receive multimodal exercise program for half year control group: participate community activity
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shui Tseng, Study chair, Chang Gung Medical Foundation Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668886
- Sponsor's protocol ID
- 2001800707B0
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Exercise Program in Musculoskeletal System of the Community Elderly
- ClinicalTrials.gov ID
- NCT03668886
- Acronym / sponsor ID
- 2001800707B0
- Conditions
- Elderly Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group: receive multimodal exercise program for half year control group: participate community activity
| Arm | Type | Receives |
|---|---|---|
| multimodal exercise program | Experimental | Other: multimodal exercise programElderly in this group will receive multimodal exercise program. The duration of exercise is 60 minutes and frequency is 2 times/week. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- >= 65 year old
Key exclusion criteria (2 listed)
- cognitive impairment and poor understanding for orders
- the elderly has medical problems that the elderly can't perform exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal exercise programwarm-up, strengthening exercise, aerobic exercise, cool-down | Other | multimodal exercise program |
Primary outcome
Gait speed
Time frame: change between two time points (baseline, 3 months later)
measure gait speed as usual
Gait speed
Time frame: change between two time points (baseline, 6 months later)
measure gait speed as usual
23 secondary outcomes
Muscle mass
Time frame: 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)
Level (mild, moderate, maximal) of daily activity
Time frame: change between two time points (baseline, 6 months later)
Zipper test
Time frame: change between two time points (baseline, 3 months later)
Zipper test
Time frame: change between two time points (baseline, 6 months later)
Sit and reach test
Time frame: change between two time points (baseline, 3 months later)
Sit and reach test
Time frame: change between two time points (baseline, 6 months later)
Biceps strength
Time frame: change between two time points (baseline, 3 months later)
Biceps strength
Time frame: change between two time points (baseline, 6 months later)
Strength of lower limbs
Time frame: change between two time points (baseline, 3 months later)
Strength of lower limbs
Time frame: change between two time points (baseline, 6 months later)
One leg stand test
Time frame: change between two time points (baseline, 3 months later)
One leg stand test
Time frame: 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)
Timed up and go test
Time frame: change between two time points (baseline, 6 months later)
Endurance
Time frame: change between two time points (baseline, 3 months later)
Endurance
Time frame: 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)
Range of motion of knee
Time frame: 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)
Pain, stiffness, physical function of knee
Time frame: change between two time points (baseline, 6 months later)
Grip strength
Time frame: change between two time (baseline, 3 months later)
Grip strength
Time frame: change between two time (baseline, 6 months later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shui Tseng study chair
Chang Gung Medical Foundation Institutional Review Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multimodal exercise program in people with Elderly Exercise, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: change between two time points (baseline, 3 months later)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.