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Studies

Interventional Active not recruiting

NCT06669455 on ClinicalTrials.gov

An Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease

Official title: SENSS (Stress, Exercise, Nutrition, Sleep, Self-management): An Integrated, Personalized and Stepped Care Lifestyle Approach for People With Parkinson's Disease: A Randomized Controlled Trial

  • Sponsor: Radboud University Nijmegen Medical Centre
  • Enrollment: 256 (Estimated)
  • Study start: 2024-11-12 (Actual)
  • Primary completion: 2027-03-01 (Estimated)
  • Study completion: 2027-03-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Investigator)
  • PrimaryPurpose: Supportive Care

Brief Summary

The goal of this study is to investigate the effects of a combined lifestyle program on the quality of life in people with Parkinson's Disease.

Participants will be randomly assigned to one of two groups, both receiving standard care, a Parkinson Lifestyle Decision aid and an intake meeting with a lifestyle coach. One group will work on their goals independently, while the other group will get guidance from the lifestyle coach throughout the 12-month program. The program focuses on self-management, exercise, nutrition, sleep and stress.

Participants will complete questionnaires after 0, 6 and 12 months, and use a wearable sensor for two weeks. The main outcome is quality of life over 12 months, measured with the PDQ-39 questionnaire. The study also examines personal goal achievements, symptom changes, and the economic effects of the program.

Conditions

  • Parkinson Disease

Intervention / Treatment

  • Behavioral: Personalized and combined lifestyle approach

Primary Outcome Measures

  • Change in quality of life measured with the PDQ-39. (Measured at baseline, and after 6 and 12 months.)
    The PDQ-39 consists of 39 questions across 8 dimensions of daily living including relationships, social situations and communication. Item scores range on a 5-point scale from "never" to "always". Both the total score of the PDQ-39 and the scores for each of the 8 dimensions are considered primary outcomes.

Countries

Netherlands

Locations and Investigators

  • Radboud University Medical Center, Nijmegen, Netherlands