NCT02509611

Brief Summary

The study's purpose is to assess the effect of yoga on measures of oxidative stress (i.e. reduction-oxidation \[redox\] status); motor function; and psychosocial well-being, and the feasibility and acceptability of implementing a Hatha yoga program in PD subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 31, 2018

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

July 20, 2015

Last Update Submit

May 30, 2018

Conditions

Keywords

YogaParkinson's diseaseredox statusmotor function

Outcome Measures

Primary Outcomes (1)

  • Redox status

    The antioxidant glutathione (GSH) and the GSH: glutathione disulfide (GSSG) ratio will be measured at baseline and at the end of the program.

    12 weeks

Secondary Outcomes (8)

  • Motor function

    12 weeks

  • Motor function

    12 weeks

  • Motor function

    12 weeks

  • Cognitive function

    12 weeks

  • Mood

    12 weeks

  • +3 more secondary outcomes

Other Outcomes (3)

  • Yoga feasibility

    Baseline and 12 weeks

  • Yoga acceptability

    12 weeks

  • Yoga program fidelity

    4 weeks, 8 weeks, and 12 weeks

Study Arms (2)

Immediate treatment

EXPERIMENTAL

Participants who are randomly assigned to the immediate treatment group will receive 60-minute biweekly Hatha yoga for 12 weeks.

Other: Hatha yoga

Waitlist control

ACTIVE COMPARATOR

Participants who are randomly assigned to the wait-list group will receive no intervention during the first 12 weeks. Not only will they serve as the comparative group, they will also serve as their own control and receive the same yoga intervention at the end of 12 weeks when the immediate treatment group completed their program.

Other: Hatha yoga

Interventions

Yoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program. Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program. The yoga intervention classes will be taught by a Registered Yoga Teacher. The 60 minute long yoga session will be held twice a week for 12 weeks at a community center in St. Louis Park.

Also known as: Yoga
Immediate treatmentWaitlist control

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with idiopathic PD;
  • On optimized dopaminergic therapy for 4 weeks prior to enrollment; and
  • Have not practiced any form of yoga regularly (more than 2 days a week) in the past 6 months; and
  • Not currently participating in a supervised exercise program more than 2 days a week

You may not qualify if:

  • Atypical Parkinsonism or other significant brain conditions such as a stroke;
  • Fell more than once in the past 3 months;
  • Moderate to severe cognitive impairment (scored \<26) as indicated by the Montreal Cognitive Assessment;
  • Decline in immune function such as pneumonia or systemic infection;
  • Spinal fusion or other orthopedic surgery in the past 6 months;
  • Unstable cardiovascular conditions;
  • Significant mental disease or psychosis;
  • Not able to ambulate 6 meters steadily without assistive device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

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

  • Corjena Cheung, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 28, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

May 31, 2018

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations