Feasibility of a community-based, personalized multimodal exercise program for Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-randomized feasibility study assesses whether a 12-week multimodal exercise program can be implemented in real-world Parkinson's disease settings, with a matched non-exercise control group for comparison. Participants are recruited sequentially and matched by sex, age, and disease stage, with assessments at baseline, after the program, and at 6 months. Outcomes include feasibility metrics (recruitment, adherence, safety) and preliminary effects on motor and non-motor symptoms, physical fitness, and pain-related outcomes. The program emphasizes individualised adjustments within a group format to accommodate varied symptom severity and progression. The study is conducted in collaboration between Universidad Rey Juan Carlos and Asociación Parkinson Madrid in Madrid, Spain.

Why it matters

Who can join: the full rules

Eligibility Criteria The eligibility criteria will be identical for both the experimental and control groups. However, this study will employ a sequential recruitment design. To provide preliminary comparative information regarding effectiveness, a matched non-exercise control group was included. Frequency matching will be used at the group level according to sex, 10-year age categories and Hoehn \& Yahr stage categories (1-1.5, 2-2.5 and 3). Individual 1:1 matching will not be required.

Inclusion Criteria:

* Subjects diagnosed with Idiopathic Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria.
* Subjects staged between 1 and 3 on the Hoehn \& Yahr Scale. For matching purposes, stage 1 includes stage 1.5, and stage 2 includes stage 2.5.

Exclusion Criteria:

* Subjects diagnosed with a neurological disease other than PD.
* Those diagnosed with a cardiovascular, respiratory, or metabolic disease or other conditions that represent a contraindication to physical exercise.
* Those who have suffered an exacerbation or hospitalization in the last three months prior to starting the assessment protocol or during the therapeutic intervention process.
* Those who have received a course of steroids, intravenously or orally, six months prior to the start of the study or during the therapeutic intervention process.
* Those with cognitive impairment (defined as a score \< 21 on the Montreal Cognitive Assessment, MoCA) or language impairments that prevent adequate communication, comprehension, or following of exercise instructions.
* Participation in a structured, individualized strength and/or aerobic exercise program within the three months prior to enrollment.

Where it's running

• Universidad Rey Juan Carlos
  Alcorcón, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Mario González Iglesias, Physiotherapy — Universidad Rey Juan Carlos
• Study coordinator: Mario González Iglesias, MSc PhD Student, Physiotherapy
• Email: mario.gonzalez@urjc.es
• Phone: 622 113 365

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.