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NCT07618728From ClinicalTrials.govRecruiting

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

Feasibility and Preliminary Effectiveness of an Individualised Multimodal Group-Based Exercise Programme for People With Parkinson's Disease: A Non-Randomized Feasibility Study

  • PARKINSON DISEASE (Disorder)

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Universidad Rey Juan Carlos
Enrolment target
64
Started
8 September 2025
Main results due
29 May 2026
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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. Participants for the control group will be recruited following the experimental group and will be matched (1:1 ratio) based on sex, age (± 5 years), and disease severity according to the Hoehn \& Yahr (H\&Y) scale.

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Universidad Rey Juan Carlos

    Alcorcón, Madrid, Spain

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07618728. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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