ElderlyNCT03607136
Early Detection of Disability and Health Promotion for Community-dwelling Elderly
A study testing exercise training in people with Elderly and Sarcopenia, run by Buddhist Tzu Chi General Hospital.
Trial summary
This study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. Half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly, Sarcopenia
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Jul 2020
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age greater than 50 years
- able to follow simple instructions
- willing to participate and sign consent form
Who cannot join
- unstable angina or epilepsy
- severe visual deficits
- cognitive dysfunction
- other musculoskeletal conditions that will limit mobility
About this study
Official title: Department of Physical Therapy, Tzu Chi University
This study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. Half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living.
Read the detailed description
Physical inactivity can result in physical frailty and sarcopenia. Physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality.
Regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. Nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. One of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.
- Conditions
- Elderly, Sarcopenia
- Being tested
- exercise training
- Keywords
- early detection, health promotion, community-dwelling, elderly
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
Aerobic exercises, strengthening exercises, flexibility training for 60min, twice a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| exercise training | Experimental | Participants in the exercise training group received a 12-week exercise training. Receives: Other: exercise training |
| control | No intervention | Participants in the control group did not receive any specific training programs instead of maintaining their usual activities of daily living. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
Participants are asked to walk along a 14 m hallway. The time taken to the middle 10 m is recorded to calculate walking speed (m/s).
Measured: Change from baseline at 12 weeks
Muscle strength
Muscle strength is assessed using hand-hold Dynamometers
Measured: Change from baseline at 12 weeks
Secondary outcomes (5)
Timed up and go test
Participants are asked to stand up, walk 3 m, turn around a cone, and return to a sitting position
Measured: Change from baseline at 12 weeks
Walking endurance
Participants are asked to walk back and forth along a 20-meter corridor and to cover the maximum distance possible in six minutes
Measured: Change from baseline at 12 weeks
Sit-to-stand test
Participants are asked to stand up and sit down 5 times.
Measured: Change from baseline at 12 weeks
Berg balance scale
It consists of 14 items, including sitting unsupported, standing unsupported, standing with eyes closed, standing with feet together, standing on one foot, turning to look behind, retrieving objective from floor, random standing, reaching forward with an outsrptretched arm, sit to stand, stand to sit, transfer, turning 360 degrees, stool stepping, scored from 0 to 4, "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56.
Measured: Change from baseline at 12 weeks
Gait kinematics
Gait kinematics are assessed by angular displacement of lower limbs using shoe-worn inertial measurement unit based device
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607136
- Sponsor's protocol ID
- IRB106-75-A-2
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Physical Therapy, Tzu Chi University
- ClinicalTrials.gov ID
- NCT03607136
- Acronym / sponsor ID
- IRB106-75-A-2
- Conditions
- Elderly, Sarcopenia
- Keywords
- early detection, health promotion, community-dwelling, elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 31 Jul 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.
This study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. Half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living.
Detailed description
Physical inactivity can result in physical frailty and sarcopenia. Physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality.
Regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. Nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. One of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise training | Experimental | Other: exercise trainingParticipants in the exercise training group received a 12-week exercise training. |
| control | No intervention | –Participants in the control group did not receive any specific training programs instead of maintaining their usual activities of daily living. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than 50 years
- able to follow simple instructions
- willing to participate and sign consent form
Key exclusion criteria (4 listed)
- unstable angina or epilepsy
- severe visual deficits
- cognitive dysfunction
- other musculoskeletal conditions that will limit mobility
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 trainingAerobic exercises, strengthening exercises, flexibility training for 60min, twice a week for 12 weeks | Other | exercise training |
Primary outcome
Walking speed
Time frame: Change from baseline at 12 weeks
Participants are asked to walk along a 14 m hallway. The time taken to the middle 10 m is recorded to calculate walking speed (m/s).
Muscle strength
Time frame: Change from baseline at 12 weeks
Muscle strength is assessed using hand-hold Dynamometers
5 secondary outcomes
Timed up and go test
Time frame: Change from baseline at 12 weeks
Walking endurance
Time frame: Change from baseline at 12 weeks
Sit-to-stand test
Time frame: Change from baseline at 12 weeks
Berg balance scale
Time frame: Change from baseline at 12 weeks
Gait kinematics
Time frame: Change from baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Elderly and Sarcopenia, run by Buddhist Tzu Chi General Hospital.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Walking speed (time frame: Change from baseline at 12 weeks). 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 31 Jul 2018.