Exercise TrainingNCT03660254
Effect of Tai Chi on Functional Fitness of Elderly Patients With Degenerative Arthritis
A study testing tai chi in people with Exercise Training, run by Chen Li Tien at 1 site in Taiwan.
Trial summary
Degenerative arthritis is a common disease in the elderly , in recent years, there are young trends, the symptoms often cause great pain in the elderly, associated with lower physical exercise caused by decreased muscle mass, functional fitness performance Is also poor, affecting the ability of elderly people to live… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Exercise Training
- What is being tested?
- tai chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2017to 28 Feb 2018
- 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 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly persons aged 65 or above who actively participate in community activities
- awareness MMSE score ≧ 25 and can use the Chinese, Taiwanese fluent communication
- can stand for more than 60 minutes and the Kirsley scale for the second to zero level.
Who cannot join
- medical advice for those who can not exercise
- suffering from significant cardiovascular and heart disease
- suffering from high blood pressure, asthma, diabetes
- those suffering from skeletal muscle disease
Trial locations and contacts
1 site in 1 country.
About this study
Degenerative arthritis is a common disease in the elderly , in recent years, there are young trends, the symptoms often cause great pain in the elderly, associated with lower physical exercise caused by decreased muscle mass, functional fitness performance Is also poor, affecting the ability of elderly people to live independently. Therefore, this study mainly explores whether the intervention of tai chi can improve the functional fitness of the elderly and reduce the pain index of the elderly. The study was designed to take the sample, which was divided into experimental group and control group. It was expected to receive 100 people. The subjects were asked to use the basic information, Karnofsky scale, The functional fitness test, the exercise conscious scale and the WOMAC pain scale were used as the research tools. The SPSS system was used to analyze whether the functional fitness index and the pain index were significantly different before and after exercise intervention. Whether the exercise intervention has an effect on the elderly.
Read the detailed description
Degenerative arthritis is a common disease in the elderly , in recent years, there are young trends, the symptoms often cause great pain in the elderly, associated with lower physical exercise caused by decreased muscle mass, functional fitness performance Is also poor, affecting the ability of elderly people to live independently. Therefore, this study mainly explores whether the intervention of tai chi can improve the functional fitness of the elderly and reduce the pain index of the elderly. The study was designed to take the sample, which was divided into experimental group and control group. It was expected to receive 100 people. The subjects were asked to use the basic information, Karnofsky scale, The functional fitness test, the exercise conscious scale and the WOMAC pain scale were used as the research tools. The SPSS system was used to analyze whether the functional fitness index and the pain index were significantly different before and after exercise intervention. Whether the exercise intervention has an effect on the elderly.
- Conditions
- Exercise Training
- Being tested
- tai chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tai chiBehavioural
tai chi exercise intervention,two times a week and each time cost one hour
| Study group | Role | What they receive |
|---|---|---|
| one group has exercise intervention | Experimental | tai chi exercise intervention,two times a week and each time costs one hour Receives: Behavioral: tai chi |
| no intervention | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
height
Measuring the height of the subject
Measured: 1 min
Weight
Measuring the weight of the subject
Measured: 1 min
Muscle strength
measuring how many times of "sit and down" can he do in 30 secs
Measured: 1 min
Endurance
measuring how many times can he do "knee pull-in" in 2 mins
Measured: 2 mins
Heart rate
measuring heart rate before and after knee pull-in
Measured: 2 mins
Softness(sit and reach test)
sitting on the floor with legs stretched out straight ahead, With the palms facing downwards, and the hands on top of each other or side by side, the subject reaches forward along the measuring line as far as possible.
Measured: 1 min
balance(One foot station)
measuring how long can he stand in one foot
Measured: 2 mins
walking
walking for 10 meters and measuring how long participants take
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Dec 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Li Tien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Li Tien, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660254
- Sponsor's protocol ID
- b409103042@tmu.edu.tw
- Status last verified
- Sep 2018
- First submitted
- 22 May 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tai Chi on Functional Fitness of Elderly Patients With Degenerative Arthritis
- ClinicalTrials.gov ID
- NCT03660254
- Acronym / sponsor ID
- b409103042@tmu.edu.tw
- Conditions
- Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Chen Li TienUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 6 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.
Degenerative arthritis is a common disease in the elderly , in recent years, there are young trends, the symptoms often cause great pain in the elderly, associated with lower physical exercise caused by decreased muscle mass, functional fitness performance Is also poor, affecting the ability of elderly people to live independently. Therefore, this study mainly explores whether the intervention of tai chi can improve the functional fitness of the elderly and reduce the pain index of the elderly. The study was designed to take the sample, which was divided into experimental group and control group. It was expected to receive 100 people. The subjects were asked to use the basic information, Karnofsky scale, The functional fitness test, the exercise conscious scale and the WOMAC pain scale were used as the research tools. The SPSS system was used to analyze whether the functional fitness index and the pain index were significantly different before and after exercise intervention. Whether the exercise intervention has an effect on the elderly.
Detailed description
Degenerative arthritis is a common disease in the elderly , in recent years, there are young trends, the symptoms often cause great pain in the elderly, associated with lower physical exercise caused by decreased muscle mass, functional fitness performance Is also poor, affecting the ability of elderly people to live independently. Therefore, this study mainly explores whether the intervention of tai chi can improve the functional fitness of the elderly and reduce the pain index of the elderly. The study was designed to take the sample, which was divided into experimental group and control group. It was expected to receive 100 people. The subjects were asked to use the basic information, Karnofsky scale, The functional fitness test, the exercise conscious scale and the WOMAC pain scale were used as the research tools. The SPSS system was used to analyze whether the functional fitness index and the pain index were significantly different before and after exercise intervention. Whether the exercise intervention has an effect on the elderly.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one group has exercise intervention | Experimental | Behavioral: tai chitai chi exercise intervention,two times a week and each time costs one hour |
| no intervention | No intervention | –no intervention |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderly persons aged 65 or above who actively participate in community activities
- awareness MMSE score ≧ 25 and can use the Chinese, Taiwanese fluent communication
- can stand for more than 60 minutes and the Kirsley scale for the second to zero level.
Key exclusion criteria (4 listed)
- medical advice for those who can not exercise
- suffering from significant cardiovascular and heart disease
- suffering from high blood pressure, asthma, diabetes
- those suffering from skeletal muscle disease
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 |
|---|---|---|
| tai chitai chi exercise intervention,two times a week and each time cost one hour | Behavioural | one group has exercise intervention |
Primary outcome
height
Time frame: 1 min
Measuring the height of the subject
Weight
Time frame: 1 min
Measuring the weight of the subject
Muscle strength
Time frame: 1 min
measuring how many times of "sit and down" can he do in 30 secs
Endurance
Time frame: 2 mins
measuring how many times can he do "knee pull-in" in 2 mins
Heart rate
Time frame: 2 mins
measuring heart rate before and after knee pull-in
Softness(sit and reach test)
Time frame: 1 min
sitting on the floor with legs stretched out straight ahead, With the palms facing downwards, and the hands on top of each other or side by side, the subject reaches forward along the measuring line as far as possible.
balance(One foot station)
Time frame: 2 mins
measuring how long can he stand in one foot
walking
Time frame: 1 min
walking for 10 meters and measuring how long participants take
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 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tai chi in people with Exercise Training, run by Chen Li Tien 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 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: finished, as of the sponsor's last update on 6 Sep 2018. 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?
height (time frame: 1 min). The study lists 8 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 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.