NCT05410392

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2023Oct 2026

First Submitted

Initial submission to the registry

June 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3.2 years

First QC Date

June 2, 2022

Last Update Submit

December 9, 2025

Conditions

Keywords

Parkinson's diseasePain

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

    Change in pain severity score from baseline to 3-month follow-up is the outcome

    3 months

Study Arms (4)

Combined physical and cognitive exercise intervention

EXPERIMENTAL

Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.

Behavioral: Physical exercise interventionBehavioral: Cognitive exercise intervention

Physical exercise intervention

EXPERIMENTAL

Participants will receive the physical exercise intervention for 3 months.

Behavioral: Physical exercise intervention

Cognitive exercise intervention

EXPERIMENTAL

Participants will receive the cognitive exercise intervention for 3 months.

Behavioral: Cognitive exercise intervention

Control group

ACTIVE COMPARATOR

Participants will receive health education for 3 months.

Behavioral: Health education

Interventions

Home-based cognitive exercise with the use of smartphone to complete cognitive activities.

Cognitive exercise interventionCombined physical and cognitive exercise intervention

Provision of general information about a variety of topics

Control group

Home-based physical exercise with the use of a stationary recumbent style bike.

Combined physical and cognitive exercise interventionPhysical exercise intervention

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosis of idiopathic PD
  • At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
  • Response to dopaminergic medication

You may not qualify if:

  • Angina pectoris
  • History of myocardial infarction (MI) within 6 months
  • History of ventricular dysrhythmia requiring current therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseasePain

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David William Sparrow, DSc

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David W Sparrow, DSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 8, 2022

Study Start

January 1, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations