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Completed

NCT Number: NCT02902510

Therapeutic Yoga to Improve Function in Parkinson's Disease

This is a single blind, randomized, wait-list controlled, phase II exploratory pilot study.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Therapeutic yoga for people with Parkinson's Disease

Other

Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.

Other names: Yoga

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. 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

    frequency of freezing of gait and disturbances in gait.

  2. 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

    measures level of fatigue and impact of fatigue on daily functioning.

  3. 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

    Examines perceived confidence in performing various ambulatory activities with falling.

  4. 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

    Measures perceived constraints to activity participation.

  5. 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

    Measures quality of life for individuals with PD.

Sponsors and collaborators

Lead sponsor

Clemson University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 15, 2016
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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