NCT02902510

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

September 5, 2016

Last Update Submit

September 14, 2016

Conditions

Keywords

yogafunctionParkinson's diseasegaitbalance

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    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

    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

    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

    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

    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

    baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period

Study Arms (2)

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.

Other: Therapeutic yoga for people with Parkinson's Disease

Wait List Control

NO INTERVENTION

There was no intervention during the WLC.

Interventions

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

Also known as: Yoga
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Yoga

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Marieke Van Puymbroeck, PhD

    Clemson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 15, 2016

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share