Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)

NCT04922190 | Active Not Recruiting Phase 1

• 1 other identifier: 20-005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Engage-PD is a single cohort evaluation of implementation of a telehealth-delivered physical activity coaching program for people with early-mid stage Parkinson's disease. The program utilizes a physical or occupational therapist to provide one-on-one coaching for individuals with early-mid stage Parkinson's disease to provide individualized structured support to facilitate and optimize exercise uptake as part of an effective self-management program. The structure of the coaching program is based on previous research in neurodegenerative disease including Parkinson's disease and Huntington's disease.

Conditions

Parkinson Disease

Keywords

physical activity; exercise; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Brunel Lifestyle Physical Activity Questionnaire

  The Brunel lifestyle inventory is a 10-item questionnaire that measures both pre-planned (6 items) and un-planned (3 items) lifestyle PA. Scoring for each item is on a scale of 1-5, and the scores for each subscale are averaged. Scores range from 1 (low level of physical activity) to 5 (high level of physical activity).

  3 months

• Self-Efficacy for Exercise Scale

  18-item test that measures an individual's self-efficacy to participate in exercise when numerous barriers are present, including both social and physical barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.

  3 months

Secondary Outcomes (7)

• International Physical Activity Questionnaire (Short-Form Phone version)

  3 months

• NeuroQOL

  3 months

• Brief Pain Inventory

  3 months

• Timed Up and Go

  3 months

• Standing balance assessment

  3 months

Study Arms (1)

Physical Activity Coaching

EXPERIMENTAL

Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.

Behavioral: Physical Activity Coaching

Interventions

Physical Activity Coaching BEHAVIORAL

Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.

Physical Activity Coaching

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurologist confirmed clinical diagnosis for Parkinson's disease Hoehn \& Yahr stage I-III
• Ambulatory for indoor and outdoor mobility without assistance or assistive device
• Successful completion of Physical Activity Readiness Questionnaire (PAR-Q)26 or medical clearance from GP

You may not qualify if:

• Musculoskeletal injury that would prevent participation in an exercise program
• Other neurological disease or disorder such as stroke

Sponsors & Collaborators

• Teachers College, Columbia University: lead
• Columbia University: collaborator

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: March 15, 2020
• Primary Completion: April 15, 2024
• Study Completion: December 31, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)