Pre-Active PD: Looking At Physical Activity Behavior Change in Parkinson's Disease

NCT05308238 | Completed

• 1 other identifier: MJF.AOTF.1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Pre-Active PD is a randomized controlled feasibility study to evaluate the implementation of a telehealth-delivered physical activity behavior change intervention for people with early-mid stage Parkinson's disease. The program utilizes occupational therapists to provide one-to-one individualized support to facilitate and optimize exercise uptake as part of their disease self-management. The structure of the intervention is based on previous research in neurodegenerative disease including Parkinson's disease and Huntington's disease.

Conditions

Parkinson Disease

Keywords

behavior change; exercise; physical activity; occupational therapy

Outcome Measures

Primary Outcomes (4)

• Feasibility: Adherence

  Participant completion of ≥ 75% of sessions 1, 2 \& 3

  4 months

• Feasibility: Retention

  \> 75% of all participants retained at follow-up

  4 months

• Change from baseline Brunel Lifestyle Physical Activity Questionnaire (Karageorghis, 2005) at 4 months and 6 months

  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).

  Baseline, 4 months, and 6 months

• Change From Baseline Moderate-Vigorous Physical Activity Using Actigraph at 4 Months and 6 months

  Measured using ActiGraph accelerometer, levels of moderate-vigorous physical activity will be measured, as well as number of steps and sedentary behavior.

  Baseline, 4 months, and 6 months

Secondary Outcomes (11)

• Change From Baseline Timed-up-and-go (TUG) at 4 Months and 6 months

  Baseline, 4 months, and 6 months

• Change From Baseline 30 second sit-to-stand at 4 Months and 6 months

  Baseline, 4 months, and 6 months

• Change From Baseline Modified 2 Minute Step Test at 4 Months and 6 months

  Baseline, 4 months, and 6 months

• Change From Baseline Perceived Functional Ability (PFA) Questionnaire (George et al., 1997) at 4 Months and 6 months

  Baseline, 4 months, and 6 months

• Change From Baseline Modified Canadian Occupational Performance Measure (Dedding et al., 2004) at 4 Months and 6 months

  Baseline, 4 months, and 6 months

Study Arms (2)

Occupational therapy intervention group

EXPERIMENTAL

Participants will receive 6 telehealth coaching sessions and 8 brief email or text check-ins over the course of 4 months. Participants will also receive a Fitbit and Engage PD Workbook.

Behavioral: Occupational therapy intervention group

Disease management education group

ACTIVE COMPARATOR

Participants will receive online educational videos that they can watch at their own convenience over the course of 4 months. There will be up to 6 hours of content, and the links to these online videos will be provided via email. Following completion of the study, individuals in this group will receive an Engage PD Workbook and one OT coaching session, if they choose to.

Behavioral: Disease management education group

Interventions

Occupational therapy intervention group BEHAVIORAL

Participants will receive 6 telehealth coaching sessions and 8 brief email or text check-ins over the course of 4 months. Participants will also receive a Fitbit and Engage PD Workbook.

Occupational therapy intervention group

Disease management education group BEHAVIORAL

Participants will receive online educational videos that they can watch at their own convenience over the course of 4 months. There will be up to 6 hours of content, and the links to these online videos will be provided via email. Following completion of the study, individuals in this group will receive an Engage PD Workbook and one OT coaching session, if they choose to.

Disease management education group

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

You may not qualify if:

• Musculoskeletal injury that would prevent participation in an exercise program
• Other neurological diseases or disorders such as stroke
• Already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week.

Sponsors & Collaborators

• San Jose State University: lead
• Teachers College, Columbia University: collaborator

Study Sites (2)

San Jose State Universty

San Jose, California, 95192-0059, United States

Location

Neurorehabilitation Research Laboratory

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: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled feasibility study

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: April 4, 2022
• Study Start: April 18, 2022
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: February 19, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)