Parkinson's DiseaseNCT02902510
Therapeutic Yoga to Improve Function in Parkinson's Disease
A study testing Therapeutic yoga for people with Parkinson's Disease in people with Parkinson's Disease, run by Clemson University.
Trial summary
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Therapeutic yoga for people with Parkinson's Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's Disease with a rating of 1.5-4 on the Modified Hoehn and Yahr Scale of Parkinson's Disease Progression
- Endorsement of FoF,44 able to stand and walk 10 meters with or without an assistive device
- >18 years old; able to speak English
- Score >4 out of 6 on the short Mini Mental Status Exam
- Able and willing to attend twice weekly sessions for 8 weeks
Who cannot join
- People with self-reported life expectancy <12 months
- Inability to attend sessions due to transportation issues
- Current involvement with other physical activity (including yoga), rehabilitation, or other intervention studies
- Inability or refusal to provide informed consent
About this study
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.
Read the detailed description
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study utilizing an after-trial embedded mixed methods approach that will examine the efficacy of therapeutic yoga as a rehabilitation strategy for individuals with PD to improve balance and reduce fear of falling (FoF). Potential participants will have a FoF in order to enter the study. An after-trial embedded mixed methods design will be employed in this study and will include the collection of qualitative data to assist in the overall interpretation of the more heavily weighted quantitative trial data. Adding qualitative methods will serve as a post-hoc analysis capturing participant perceptions of the relationships between the yoga intervention and various outcomes. More specifically, the qualitative data will aide in explaining the link between the various yoga techniques and mechanisms that participants attribute to improved balance, reduced FoF, and other bio-psychosocial outcomes and experiences. Qualitative data will be collected using focus group interviews with participants in the yoga group at the end of the class in week 8.
- Conditions
- Parkinson's Disease
- Being tested
- Therapeutic yoga for people with Parkinson's Disease
- Keywords
- yoga, function, Parkinson's disease, gait, balance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic yoga for people with Parkinson's DiseaseOther
Also called Yoga
Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group is the group that received yoga. The individuals originally assigned to the WLC who completed the yoga intervention AFTER the 8 weeks WLC period also are considered part of the experimental group. Receives: Other: Therapeutic yoga for people with Parkinson's Disease |
| Wait List Control | No intervention | There was no intervention during the WLC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks
A performance based assessment of motor function.
Measured: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Mini BESTest at 8 weeks
clinical balance assessment tool that targets 4 balance control systems, including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait
Measured: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Functional Gait Assessment at 8 weeks
assesses postural stability during 10 walking tasks
Measured: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Secondary outcomes (5)
Change in Freezing of Gait Questionnaire at 8 weeks
frequency of freezing of gait and disturbances in gait.
Measured: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Parkinson's Fatigue Scale at 8 weeks
measures level of fatigue and impact of fatigue on daily functioning.
Measured: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Activity Balance Confidence Scale at 8 weeks
Examines perceived confidence in performing various ambulatory activities with falling.
Measured: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Activity Constraints Scale at 8 weeks
Measures perceived constraints to activity participation.
Measured: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks
Measures quality of life for individuals with PD.
Measured: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marieke Van Puymbroeck, PhD, Principal investigator, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902510
- Sponsor's protocol ID
- Pro00041068
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Yoga to Improve Function in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02902510
- Acronym / sponsor ID
- Pro00041068
- Conditions
- Parkinson's Disease
- Keywords
- yoga, function, Parkinson's disease, gait, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Sep 2016 (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.
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.
Detailed description
This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study utilizing an after-trial embedded mixed methods approach that will examine the efficacy of therapeutic yoga as a rehabilitation strategy for individuals with PD to improve balance and reduce fear of falling (FoF). Potential participants will have a FoF in order to enter the study. An after-trial embedded mixed methods design will be employed in this study and will include the collection of qualitative data to assist in the overall interpretation of the more heavily weighted quantitative trial data. Adding qualitative methods will serve as a post-hoc analysis capturing participant perceptions of the relationships between the yoga intervention and various outcomes. More specifically, the qualitative data will aide in explaining the link between the various yoga techniques and mechanisms that participants attribute to improved balance, reduced FoF, and other bio-psychosocial outcomes and experiences. Qualitative data will be collected using focus group interviews with participants in the yoga group at the end of the class in week 8.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Therapeutic yoga for people with Parkinson's DiseaseThe experimental group is the group that received yoga. The individuals originally assigned to the WLC who completed the yoga intervention AFTER the 8 weeks WLC period also are considered part of the experimental group. |
| Wait List Control | No intervention | –There was no intervention during the WLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Parkinson's Disease with a rating of 1.5-4 on the Modified Hoehn and Yahr Scale of Parkinson's Disease Progression
- Endorsement of FoF,44 able to stand and walk 10 meters with or without an assistive device
- >18 years old; able to speak English
- Score >4 out of 6 on the short Mini Mental Status Exam
- Able and willing to attend twice weekly sessions for 8 weeks
Key exclusion criteria (4 listed)
- People with self-reported life expectancy <12 months
- Inability to attend sessions due to transportation issues
- Current involvement with other physical activity (including yoga), rehabilitation, or other intervention studies
- Inability or refusal to provide informed consent
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 |
|---|---|---|
| Therapeutic yoga for people with Parkinson's DiseaseAlso: YogaHeld for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week. | Other | Experimental |
Primary outcome
Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks
Time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
A performance based assessment of motor function.
Change in Mini BESTest at 8 weeks
Time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
clinical balance assessment tool that targets 4 balance control systems, including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait
Change in Functional Gait Assessment at 8 weeks
Time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
assesses postural stability during 10 walking tasks
5 secondary outcomes
Change in Freezing of Gait Questionnaire at 8 weeks
Time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Parkinson's Fatigue Scale at 8 weeks
Time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Activity Balance Confidence Scale at 8 weeks
Time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Activity Constraints Scale at 8 weeks
Time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks
Time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period
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 15 Sep 2016.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- 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.
Marieke Van Puymbroeck, PhD principal investigator
Clemson University
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic yoga for people with Parkinson's Disease in people with Parkinson's Disease, run by Clemson University.
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 5 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 15 Sep 2016. 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?
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?
Change in Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale at 8 weeks (time frame: baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02902510, which also lists 2 linked publications.
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 15 Sep 2016.