Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease

NCT ID: NCT03696589

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2019-04-12

Brief Summary

The purpose of this study is to assess the feasibility, in regards to acceptability and implementation, of the Pre-Active PD intervention for increased high intensity goal-directed aerobic exercise engagement in people with early-stage Parkinson's disease (Hoehn and Yahr stage I & II). In addition, the study aims to explore the effect estimates of the Pre-Active PD intervention on self-efficacy, motivation, stage of behavior change, and physical activity levels in people with early stage Parkinson's disease.

Detailed Description

The investigators will recruit 14 individuals with early stage Parkinson's disease (Hoehn and Yahr stage I & II). The investigators will conduct a single arm cohort. (pre and post intervention) pilot feasibility study over 4 months with embedded process analyses of Preactive-HD, a physical activity coaching intervention program. Previous studies conducted by the investigators will be utilized to adapt the Engage-HD physical activity coaching program to people with early stage PD. The intervention will include a participant/coach interaction and disease-specific workbook grounded within the framework of self-determination theory. The coaching sessions will be conducted by an occupational therapist and will entail six coaching sessions (either face-to-face or remote video sessions via secure Webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant). The first session (approximately 45 min) will lay the groundwork for the program, and the remaining sessions will serve to provide directed support in relation to regular physical activity and exercise. Participants will develop physical activity goals and will be supported with individual physical activity progression. Participants will be given Fitbit devices as a motivational tool and to track activity progression.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Physical Activity Coaching

Based in the self-determination theory, participants will be coached on beneficial exercises, how to utilize supports and overcome barriers to PA engagement. Emphasis of exercise coaching will be on increasing aerobic exercise engagement and will include us of Fitbit devices to facilitate uptake and monitor aerobic exercise. Intervention will be delivered by a physical or occupational therapist, who will work with the participant to develop a plan, set goals and targets, and track changes. Additional resources that will support exercise engagement will be provided. Participants will have the choice to receive their face-to-face session either in person or remotely via secure video-based service.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Neurologist confirmed clinical dx for Parkinson's disease Hoehn & Yahr stage I or II

2. Ambulatory for indoor and outdoor mobility without assistance or assistive device

3. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) (Thomas et al., 1992), or medical clearance from GP

Exclusion Criteria

1. Musculoskeletal injury that would prevent participation in an exercise program

2. Other neurological disease or disorder such as stroke

3. Already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teachers College, Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Lori Quinn

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori Quinn, EdD, PT

Role: PRINCIPAL_INVESTIGATOR

Teachers College, Columbia University

Locations

Teachers College, Columbia University

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-345

Identifier Type: -

Identifier Source: org_study_id