Parkinson's DiseaseNCT00312559
The Therapeutics Effects of Yoga in Individuals With Parkinson's Disease
A study testing Yoga Training in people with Parkinson's Disease, run by University of Kansas at 1 site in United States.
Trial summary
To determine if yoga is beneficial in improving physical function quality of life and medical status in people with Parkinson's disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Yoga Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Mar 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's Disease
- Stage 1-3 Hoehn \& Yahr
Who cannot join
- Decline in immune function
- 6 month joint surgery
- spinal fusions
- decline in mental status measured by Folstein Mini Mental Status Exam
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: The Therapeutic Effects of Yoga in Individuals With Parkinson's Disease
To determine if yoga is beneficial in improving physical function quality of life and medical status in people with Parkinson's disease
Read the detailed description
This pilot study is a randomized controlled study of 20-30 individuals with Parkinson's disease will have a control group with no training and a research group with yoga training. The control group will have the opportunity to attend yoga training of the same intensity after the study is completed. The effects of yoga will not be on the control group. Data on physical function will be derived from assessments including strength, balance, flexibility, ROM. gait, posture and functional analysis performed in the Georgia Holland Cardiopulmonary and Neuromuscular Research Lab. Questionnaires related to quality of life, depression and falls will determine psychological impact or yoga training. Vital signs, pulmonary function tests and blood draws will be done in the General Clinical research Center (GCRC) and protein analysis will be done in the diabetes research lab.
- Conditions
- Parkinson's Disease
- Being tested
- Yoga Training
- Keywords
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test, serum protein levels BP, HR, RR, strength testing using microFET, flexibility and range of motion testing using goniometer, balance/posture gait optitrk system, Berg balance scale
Secondary outcomes (2)
Unified Parkinson's Disease Rating Scale
Hoehn & Yahr Classification Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startFeb 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Investigators
- Yvonne Searls, PT, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312559
- Sponsor's protocol ID
- 10214
- Status last verified
- Aug 2007
- First submitted
- 6 Apr 2006
- Last updated
- 20 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effects of Yoga in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00312559
- Acronym / sponsor ID
- 10214
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Apr 2006 (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.
To determine if yoga is beneficial in improving physical function quality of life and medical status in people with Parkinson's disease
Detailed description
This pilot study is a randomized controlled study of 20-30 individuals with Parkinson's disease will have a control group with no training and a research group with yoga training. The control group will have the opportunity to attend yoga training of the same intensity after the study is completed. The effects of yoga will not be on the control group. Data on physical function will be derived from assessments including strength, balance, flexibility, ROM. gait, posture and functional analysis performed in the Georgia Holland Cardiopulmonary and Neuromuscular Research Lab. Questionnaires related to quality of life, depression and falls will determine psychological impact or yoga training. Vital signs, pulmonary function tests and blood draws will be done in the General Clinical research Center (GCRC) and protein analysis will be done in the diabetes research lab.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson's Disease
- Stage 1-3 Hoehn \& Yahr
Key exclusion criteria (4 listed)
- Decline in immune function
- 6 month joint surgery
- spinal fusions
- decline in mental status measured by Folstein Mini Mental Status Exam
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 |
|---|---|---|
| Yoga Training | Behavioural | – |
Primary outcome
Pulmonary function test, serum protein levels BP, HR, RR, strength testing using microFET, flexibility and range of motion testing using goniometer, balance/posture gait optitrk system, Berg balance scale
2 secondary outcomes
Unified Parkinson's Disease Rating Scale
Hoehn & Yahr Classification Scale
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 20 Aug 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.
Yvonne Searls, PT, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Training in people with Parkinson's Disease, run by University of Kansas at 1 site in United States.
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 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 20 Aug 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 United States. 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?
Pulmonary function test, serum protein levels BP, HR, RR, strength testing using microFET, flexibility and range of motion testing using goniometer, balance/posture gait optitrk system, Berg balance scale. 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 20 Aug 2007.