Therapeutic Yoga to Improve Function in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Therapeutic Yoga to Improve Function in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902510
• Other study ID #: Pro00041068
• Status: Completed
• Phase: N/A
• First received: September 5, 2016
• Last updated: September 14, 2016
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Clemson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Therapeutic yoga for people with Parkinson's Disease
Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clemson University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change in Freezing of Gait Questionnaire at 8 weeks	frequency of freezing of gait and disturbances in gait.	baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period	No
Secondary	Change in Parkinson's Fatigue Scale at 8 weeks	measures level of fatigue and impact of fatigue on daily functioning.	baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period	No
Secondary	Change in Activity Balance Confidence Scale at 8 weeks	Examines perceived confidence in performing various ambulatory activities with falling.	baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period	No
Secondary	Change in Activity Constraints Scale at 8 weeks	Measures perceived constraints to activity participation.	baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period	No
Secondary	Change in Parkinson's Disease Questionnaire (PDQ-8) at 8 weeks	Measures quality of life for individuals with PD.	baseline, 8 weeks (post-intervention), and for individuals in the WLC at the end of the 8-week waiting period	No