Telemedicine Intervention in Patients With Chronic Pain in PD

Study Overview
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Brief Summary
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Pain is a very common and disabling symptom in Parkinson's disease, yet it is often untreated. This study will assess the impact of home-based physical and cognitive exercise interventions to reduce pain in this disease. This approach would offer an easily implemented and affordable way to encourage and maintain use of these interventions by patients virtually indefinitely through remote access technology. The study findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and chronic pain.

Detailed Description
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Project Background/Rationale: Pain is one of the most disabling and common nonmotor symptoms in Parkinson's disease (PD), with a prevalence of 40-85%. Research indicates that undertreatment of pain is particularly high in the PD population. Only about one-half of patients with PD who report pain receive regular pain medications. There is increasing interest in nonpharmacological treatments for chronic pain in PD to supplement pharmacological approaches. While there is evidence to support the utility of physical exercise to improve chronic pain management, relatively less is known about the role of cognitive exercise. Project Objective: The investigators propose to conduct a pilot randomized, controlled trial in patients with chronic pain in PD to assess the impact of physical and cognitive exercise interventions on pain outcomes. Project Methods: A total of 166 community-dwelling Veterans, 40 years of age or older, with chronic pain in mild-to-moderate PD will be randomly assigned in a 2 x 2 factorial design to one of four groups (1 - combined cognitive and physical intervention, 2 - physical intervention only, 3 - cognitive intervention only, 4 - health education). The investigators will test the effects of the interventions at 3 months for the outcome of pain severity.

Official Title
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Telemedicine Intervention in Patients With Chronic Pain in PD

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Physical exercise intervention
* Behavioral: Cognitive exercise intervention
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosis of idiopathic PD At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia) Response to dopaminergic medication Exclusion Criteria: Angina pectoris History of myocardial infarction (MI) within 6 months History of ventricular dysrhythmia requiring current therapy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined physical and cognitive exercise intervention<br>Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months. | Behavioral: Physical exercise intervention<br>* Home-based physical exercise with the use of a stationary recumbent style bike.<br>Behavioral: Cognitive exercise intervention<br>* Home-based cognitive exercise with the use of smartphone to complete cognitive activities.<br>|
| Experimental: Physical exercise intervention<br>Participants will receive the physical exercise intervention for 3 months. | Behavioral: Physical exercise intervention<br>* Home-based physical exercise with the use of a stationary recumbent style bike.<br>|
| Experimental: Cognitive exercise intervention<br>Participants will receive the cognitive exercise intervention for 3 months. | Behavioral: Cognitive exercise intervention<br>* Home-based cognitive exercise with the use of smartphone to complete cognitive activities.<br>|
| Active Comparator: Control group<br>Participants will receive health education for 3 months. | Behavioral: Health education<br>* Provision of general information about a variety of topics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Severity | Change in pain severity score from baseline to 3-month follow-up is the outcome | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Pain