HealthyPhase 1NCT00451737
Correlation of 6-Minute Walk Test and Neuromuscular Parameters in the Elderly
A Phase 1 study testing Isokinetic test in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The six-minute walk test had been used to assessment the cardiopulmonary parameter in patients with lung and heart disease. And it has good reliability and validity. It has been used extensively in research into the aerobic capacity in patients of peripheral vascular disease, neural system disease, and even the… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Isokinetic test
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2006to Mar 2007
- Phase
- Phase 1
- 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
- older than 65 years old
- independent walking
Who cannot join
- diagnosis or symptoms about cardiopulmonary or neural disease
- depression
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Jan Mei Hwa
Taipei
Jan Mei Hwa, Mater, 886-2-3322-8138, mhjan@ntu.edu.tw
Han Yueh Chin, 886-2-3322-8138, jin.han@msa.hinet.net
About this study
Official title: Correlation of 6-Minute Walk Test and Neuromuscular Parameters in the Elderly: Knee Proprioception, Standing Balance, Quadriceps Muscle Strength, Endurance, and Torque Acceleration Energy
The six-minute walk test had been used to assessment the cardiopulmonary parameter in patients with lung and heart disease. And it has good reliability and validity. It has been used extensively in research into the aerobic capacity in patients of peripheral vascular disease, neural system disease, and even the muscular-skeletal system disease, such as osteoarthritis, total hip or knee arthroplasty. There were studies investigate the predictors based on cardiopulmonary factors, neuromuscular and skeletal factors of the six-minute walk distance. But the last is the neuromuscular and skeletal factors.
The purpose of this study is to investigate the correlations between the six-minute walk distance and neuromuscular parameters: muscle function (including muscle endurance, muscle strength and muscle power), knee proprioception, and standing balance. For that it could be more useful for evaluation and treatment patients in clinic.
Read more
The study was planed to select 100 subjects, they are older than 65 years old with independent walking and without any diagnosis or symptoms about cardiopulmonary or neural disease. The evaluation are including knee proprioception (closed chain, active-active test), six-minute walk test, one leg standing balance test (open and close eyes for 30 seconds), quadriceps muscle strength at velocities of 600/s,1200/s and 1800/s, quadriceps muscle power at 1800/s, and quadriceps muscle endurance.
To investigate the correlations between the six-minute walk distance and characteristics of subjects, the correlations between six-minute walk distance and neuromuscular parameters, including quadriceps muscle function (strength, endurance and power), knee proprioception, and one leg standing balance. And to analyze what's the most contribution to the six-minute walk distance.
- Conditions
- Healthy
- Being tested
- Isokinetic test
- Keywords
- Six-minute walk test, Neuromuscular system, Influence factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic testDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
six-minute walking test
knee joint reposition test
knee joint muscle strength
ankle joint muscle strength
knee joint muscle endurance
one leg standing balance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startNov 2006
- Study completionMar 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jan Mei Hwa, MS, Study director, kinesiology laborary of physical therapy in NTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451737
- Sponsor's protocol ID
- 9461712111
- Status last verified
- Jan 2006
- First submitted
- 22 Mar 2007
- Last updated
- 23 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of 6-Minute Walk Test and Neuromuscular Parameters in the Elderly: Knee Proprioception, Standing Balance, Quadriceps Muscle Strength, Endurance, and Torque Acceleration Energy
- ClinicalTrials.gov ID
- NCT00451737
- Acronym / sponsor ID
- 9461712111
- Conditions
- Healthy
- Keywords
- Six-minute walk test, Neuromuscular system, Influence factors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Mar 2007 (estimated)
- First posted
- 23 Mar 2007 (estimated)
- 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 six-minute walk test had been used to assessment the cardiopulmonary parameter in patients with lung and heart disease. And it has good reliability and validity. It has been used extensively in research into the aerobic capacity in patients of peripheral vascular disease, neural system disease, and even the muscular-skeletal system disease, such as osteoarthritis, total hip or knee arthroplasty. There were studies investigate the predictors based on cardiopulmonary factors, neuromuscular and skeletal factors of the six-minute walk distance. But the last is the neuromuscular and skeletal factors.
The purpose of this study is to investigate the correlations between the six-minute walk distance and neuromuscular parameters: muscle function (including muscle endurance, muscle strength and muscle power), knee proprioception, and standing balance. For that it could be more useful for evaluation and treatment patients in clinic.
The study was planed to select 100 subjects, they are older than 65 years old with independent walking and without any diagnosis or symptoms about cardiopulmonary or neural disease. The evaluation are including knee proprioception (closed chain, active-active test), six-minute walk test, one leg standing balance test (open and close eyes for 30 seconds), quadriceps muscle strength at velocities of 600/s,1200/s and 1800/s, quadriceps muscle power at 1800/s, and quadriceps muscle endurance.
To investigate the correlations between the six-minute walk distance and characteristics of subjects, the correlations between six-minute walk distance and neuromuscular parameters, including quadriceps muscle function (strength, endurance and power), knee proprioception, and one leg standing balance. And to analyze what's the most contribution to the six-minute walk distance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- older than 65 years old
- independent walking
Key exclusion criteria (2 listed)
- diagnosis or symptoms about cardiopulmonary or neural disease
- depression
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 |
|---|---|---|
| Isokinetic test | Device | – |
Primary outcome
six-minute walking test
knee joint reposition test
knee joint muscle strength
ankle joint muscle strength
knee joint muscle endurance
one leg standing balance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2007.
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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.
Jan Mei Hwa, MS study director
kinesiology laborary of physical therapy in NTU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Isokinetic test in people with Healthy, run by National Taiwan University 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: status not confirmed, as of the sponsor's last update on 23 Mar 2007. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six-minute walking test. The study lists 6 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 23 Mar 2007.