Behavioral Intervention for Lifestyle Physical Activity in Parkinson's Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Illinois at Chicago

About this trial

The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive function, symptoms, and quality of life (QOL), and social-cognitive theory (SCT) outcomes among physically inactive persons with Parkinson's disease (PD). Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant\'s home/community and supported by Zoom-based chats guided by SCT via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. The investigators hypothesize that the home-based exercise intervention will yield improvements in cognitive, symptomatic, and QOL outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

confirmed diagnosis of PD

Internet and email access

willingness to complete the cognitive assessments and questionnaires, wear the accelerometer, and undergo randomization

insufficient physical activity (i.e., not meeting current physical activity guidelines) based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire

Disqualifiers

above inclusion criteria not met

moderate or high risk of contraindications for possible injury or death when undertaking strenuous or maximal exercise using the PAR-Q

severe cognitive impairment that might preclude compliance with the conditions based on a modified Telephone Interview for Cognitive Status (TICS-M) score of less than 18

normal cognitive impairment based on the Montreal Cognitive Assessment (MoCA) score of 26 or more for avoiding ceiling effects involving change in cognitive function

Trial design

Design model

Parallel

Treatments tested in this trial

  • GET Up PD

    Behavioral

    * The exercise training prescription involves performing 3 days per week and include (a) aerobic exercise: 30+ minutes of moderate-intensity walking (≥100 steps/min) monitored by a waist-worn pedometer, and (b) resistance training: 1-3 sets, 8-12 repetitions of 5-10 exercises targeting lower and upper body, and core muscle groups using elastic bands. * Other components of the GET Up PD program include appropriate exercise equipment (pedometer, resistance bands), one-on-one coaching sessions via Zoom, action-planning via calendars, logbooks for self-monitoring, and SCT-based newsletters.

  • Stretching and Flexibility

    Behavioral

    * The training will involve the same frequency, duration, timeline, behavior change content, and interactions with behavioral coach as the GET Up PD program, and account for activity, social-contact, and attention. * Other components of the Stretching and Flexibility program include appropriate exercise equipment (yoga mat), one-on-one coaching sessions via Zoom, calendars, logbooks and newsletters similar to the GET Up PD program.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: GET Up PDExperimental treatment 1 intervention
Group B: Stretching and FlexibilityActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Physical Activity

ActiGraph Gt3X+ accelerometer; minutes spent in light physical activity per day

Time frame
Changes in time spent in light physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)
2

Physical Activity

ActiGraph Gt3X+ accelerometer; minutes spent in moderate-to-vigorous physical activity per day

Time frame
Changes in time spent in moderate-to-vigorous physical activity from Baseline (pre-intervention) to after 16 weeks (post-intervention)

Secondary outcomes

1

Cognitive Function

SCales for Outcomes in PArkinson's disease - COGnition (SCOPA-Cog); scores range between 0-43, higher scores indicate better cognitive function

Time frame
Changes in SCOPA-Cog Baseline (pre-intervention) to after 16 weeks (post-intervention)
2

Fatigue Severity

Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity

Time frame
Changes in fatigue severity scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
3

Depressive Symptoms

Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms

Time frame
Changes in depressive symptoms scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)
4

Fatigue Impact

Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores reflect a greater impact of fatigue on daily life

Time frame
Changes in fatigue impact scores from Baseline (pre-intervention) to after 16 weeks (post-intervention)

Other outcomes

1

Social Cognitive Theory

Exercise Self-Efficacy Scale (EXSE); scores range between 0 (not at all confident) to 100 (completely confident), higher scores indicate more self-efficacy

Time frame
Changes in exercise self-efficacy from Baseline (pre-intervention) to after 16 weeks (post-intervention)
2

Social Cognitive Theory

Barriers for Self-Efficacy Scale (BARSE); scores range between 0 (Not at all confident) to 100 (Completely confident), higher scores indicate more self-efficacy to overcome barriers to exercise

Time frame
Changes in barriers for self-efficacy from Baseline (pre-intervention) to after 16 weeks (post-intervention)
3

Social Cognitive Theory

Exercise Goal Setting (EGS); scores range between 0 and 50, higher scores indicate stronger tendency to set goals

Time frame
Changes in exercise goal setting from Baseline (pre-intervention) to after 16 weeks (post-intervention)
4

Social Cognitive Theory

Exercise Planning (EPS); scores range between 0 and 50, higher scores indicate stronger tendency to make plans to engage in exercise and physical activity

Time frame
Changes in exercise planning from Baseline (pre-intervention) to after 16 weeks (post-intervention)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

National Institute on Aging (NIA)

Collaborator

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