ExerciseNCT04812587
Effects of Exercise Training on Functional Physical Fitness, Balance and Walking in the Community-dwelling Older Adults
A study testing exercise intervention program in people with Exercise, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- exercise intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jan 2018to 6 Sep 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 81 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Independent in basic daily living activities
- At least one or more given assistance in the instrumental Instrumental Activities of Daily Living (IADL) scale
Who cannot join
- Diagnosis of neurological disease or heart disease
- Assessment do not suitable resistance exercise training, or cannot perform intense activity by doctor
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- The process of the experiment (brief describe)
- 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.
- 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.
- 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.
- After 12 weeks group exercise, the experimental group will receive the second measurements.
- Conditions
- Exercise
- Being tested
- exercise intervention program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise intervention programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: exercise intervention program |
| Comparison group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in performance of Physical fitness at 12-week
Senior Fitness test (30-second Chair Stand, 30-second Arm Curl, 2-minute Step, Chair Sit and Reach and 8 Foot Up-and-Go)
Measured: 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
Changes in Balance and walking ability at 12-week
One leg standing, Five-repetition sit-to-stand test, Timed up-and-go test and Walking speed test
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start12 Jan 2018
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Jiun Liaw, Study director, Kaohsiung Medical University Department of Physical Therapy Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812587
- Sponsor's protocol ID
- KMUHIRB-F(I)-20180002
- Status last verified
- Feb 2021
- First submitted
- 8 Mar 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently in the submission stage ,and then share with other researchers after publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Functional Physical Fitness, Balance and Walking in the Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04812587
- Acronym / sponsor ID
- KMUHIRB-F(I)-20180002
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 23 Mar 2021 (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.
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.
Detailed description
- Written informed consent must be obtained before any study specific procedures are undertaken.
- The process of the experiment (brief describe)
- 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.
- 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.
- 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.
- After 12 weeks group exercise, the experimental group will receive the second measurements.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: exercise intervention programThe 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. |
| Comparison group | No intervention | –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. |
Who may qualify
- Ages
- 65 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Independent in basic daily living activities
- At least one or more given assistance in the instrumental Instrumental Activities of Daily Living (IADL) scale
Key exclusion criteria (2 listed)
- Diagnosis of neurological disease or heart disease
- Assessment do not suitable resistance exercise training, or cannot perform intense activity by doctor
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 |
|---|---|---|
| exercise intervention programThe 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. | Behavioural | Experimental group |
Primary outcome
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)
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
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 13 Apr 2021.
- Individual participant dataSharing planned: No. Currently in the submission stage ,and then share with other researchers after publication
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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.
Li-Jiun Liaw study director
Kaohsiung Medical University Department of Physical Therapy Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention program in people with Exercise, run by Kaohsiung Medical University Chung-Ho 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 2 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 13 Apr 2021. 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?
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). 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 13 Apr 2021.