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Feasibility of a Community-Based Multimodal Exercise Programme in Parkinson's Disease

Sponsor: Universidad Rey Juan Carlos • ClinicalTrials.gov ID: NCT07618728

Registry updated: 2026-10-01

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Description

This study aims to evaluate the feasibility and preliminary effectiveness of a multimodal, group-based but individualised therapeutic exercise programme for people with Parkinson's disease delivered within a real-world community-based patient association setting. The primary objective is to assess the feasibility of implementing the programme, including recruitment, consent, adherence, intervention completion, acceptability, perceived exertion and safety. Secondary objectives are to obtain preliminary comparative information regarding the effects of the intervention on motor and non-motor symptoms, physical fitness, pain-related outcomes and exercise-induced hypoalgesia. This is a non-randomized sequential feasibility study including an intervention group participating in a 12-week multimodal exercise programme and a matched non-exercise control group maintaining usual activities. Outcomes will be assessed at baseline, post-intervention and 6-month follow-up.

Interventions

Exercise Group (Other)
In-person session structure: 1) Warm-up for 4 minutes; 2) 4 strength exercises for upper limps, trunk and lower limbs with free weights and elastic bands (3 sets per exercise); 3) Moderate to vigorous aerobic interval training / balance and coordination training (4 stations for 40 seconds, 2 sets); 4) Cognitive-motor exercise for 10 minutes; 5) Stretching and cool-down for 3 minutes. Home session structure: 1) Warm-up for 4 minutes; 2) 3 strength exercises for upper limbs, trunk and lower limbs (3 sets per exercise); 3) Moderate to vigorous aerobic interval training (4 stations for 40 seconds, 2 sets); 4) Stretching and cool-down for 3 minutes

Eligibility criteria

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.

Conditions

PARKINSON DISEASE (Disorder)

Locations

Universidad Rey Juan Carlos — Alcorcón, Madrid, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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