NCT03079817

Brief Summary

In past work is has been shown that yoga can be as effective as a standard balance or Tai Chi protocol; however, there is an inability to distinguish between the mind and body contributions of yoga training. This study will compare an accepted proprioceptive training program to a meditation program which concentrates on body awareness in individuals with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable parkinson-disease

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

Study Start

First participant enrolled

January 17, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

March 8, 2017

Last Update Submit

August 2, 2019

Conditions

Parkinson DiseaseProprioceptive DisordersMovement Disorders

Outcome Measures

Primary Outcomes (2)

  • Joint Position Sense

    The joint position sense technique for the knee involves the reduction of visual cues while moving the knee to a specific target angle, holding that target angle, returning the knee to the starting position, and then reproducing that target angle.

    20 minutes

  • Tinetti balance and gait.

    A subjective evaluation of Balance and gait.

    3 minutes.

Secondary Outcomes (3)

  • 8ft Up and Go

    60 seconds

  • Joint Kinesthesia

    20 minutes

  • Dynamic Posturography

    5 minutes

Study Arms (2)

Proprioceptive Drills

ACTIVE COMPARATOR

Includes drills during which participants perform multiplestances on a pillow, a number of different cone and line drills, reaching drills, object retrieval drills and drills using balls to disturb balance.

Other: Proprioceptive Drills

Yoga Meditation

EXPERIMENTAL

The meditation program will use simple poses during which the participant will not move and will concentrate on each of the participant's body parts and where they are in space.

Other: Yoga Meditation

Interventions

Yoga MeditationOTHER

Yoga meditation using motor imagery to perceive movement patterns

Yoga Meditation
Proprioceptive DrillsOTHER

Active balance and proprioception drills

Proprioceptive Drills

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An individual must be between 40 and 90 years of age with mild to moderate Parkinson's Disease (Hoehn \& Yahr stages I-III).

You may not qualify if:

  • Participants that have been part of a formal training program that targeted lower body strength, balance or proprioception within the past six months
  • Participants that have any uncontrolled nerve (except Parkinson's patients taking appropriate medication), bone or joint, or heart disease;
  • Participants that have been advised by a doctor to not exercise;
  • Participants that have regularly practiced yoga at least twice per week within the past six months;
  • Participants that is unable to consent;
  • Participants that is a prisoner;
  • Participants that are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Neruomuscular Research and Active Aging

Coral Gables, Florida, 33147, 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.

    PMID: 38588457DERIVED

  • 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.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson DiseaseSomatosensory DisordersMovement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph F Signorile, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 15, 2017

Study Start

January 17, 2017

Primary Completion

March 30, 2018

Study Completion

July 30, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

US(1)