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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Universidad Rey Juan Carlos
RECRUITING
Alcorcón
Contact Information
Primary
Mario González Iglesias, MSc PhD Student, Physiotherapy
mario.gonzalez@urjc.es
+34 622113365
Backup
Yeray González Zamorano, PhD, Physiotherapy
yeray.gonzalez@urjc.es
+34 689105357
Time Frame
Start Date: 2025-09-08
Estimated Completion Date: 2027-09
Participants
Target number of participants: 64
Treatments
Experimental: Exercise group
Two weekly in-person sessions of multimodal exercise that involve strength training, aerobic interval training / balance and coordination training and a cognitive-motor exercise, each session lasting 55-60 minutes. Additionally, one weekly home session lasting 25-30 minutes that include strength and aerobic training.
No_intervention: Control Group
Participants from the control group will be asked to keep their usual treatment for the duration of the study.
Related Therapeutic Areas
Sponsors
Leads: Universidad Rey Juan Carlos
Collaborators: Asociación Parkinson Madrid

This content was sourced from clinicaltrials.gov