Actively Recruiting
Feasibility and Preliminary Effectiveness of an Individualised Multimodal Group-Based Exercise Programme for People With Parkinson's Disease: A Non-Randomized Feasibility Study
Led by Universidad Rey Juan Carlos · Updated on 2026-06-03
64
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
U
Universidad Rey Juan Carlos
Lead Sponsor
A
Asociación Parkinson Madrid
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how feasible and potentially effective a multimodal, group-based but individualised exercise program is for people with Parkinson's disease when delivered in a real-world community setting such as a patient association. Parkinson's disease causes motor symptoms like slow movement, stiffness, and tremor, along with non-motor symptoms like pain, fatigue, sleep problems, and mood changes. Since some symptoms respond poorly to medication, the study explores exercise as a complementary approach. The study includes an intervention group that participates in a 12-week exercise program with two supervised face-to-face sessions per week and one home-based session weekly. The program combines strength training, cardiovascular and balance exercises, plus cognitive-motor activities, all tailored to each participant's tolerance and abilities. A matched non-exercise control group will continue their usual activities for comparison. The intervention sessions are led by physiotherapists experienced in neurological rehabilitation. Participants will be assessed at the start, after 12 weeks, and at a 6-month follow-up. Researchers will monitor feasibility outcomes such as recruitment, consent, adherence, completion rates, satisfaction, exertion levels, and safety. They will also explore changes in motor and non-motor symptoms, physical fitness, pain, and exercise-induced pain relief using various clinical scales and tests. The total study duration per participant is about 39 weeks, including follow-up assessments.
CONDITIONS
Brief Title
Feasibility of a Community-Based Multimodal Exercise Programme in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Idiopathic Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
- Staged between 1 and 3 on the Hoehn & Yahr Scale (including stages 1.5 and 2.5 for matching)
- Adults aged 18 years or older
You will not qualify if you...
- Diagnosed with a neurological disease other than Parkinson's Disease
- Diagnosed with cardiovascular, respiratory, metabolic diseases or other conditions that contraindicate physical exercise
- Experienced exacerbation or hospitalization within the last three months before assessment or during the intervention
- Received steroids (intravenously or orally) within six months before the study or during the intervention
- Cognitive impairment (Montreal Cognitive Assessment score less than 21) or language impairments preventing communication or following instructions
- Participation in a structured, individualized strength or aerobic exercise program within the three months prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants in the exercise group participate in a 12-week multimodal exercise programme including two supervised face-to-face sessions and one home-based session weekly. The sessions include strength training, aerobic and balance exercises, and cognitive-motor exercises with individualised exercise prescription and progression.
Two weekly in-person sessions and one weekly home session
Duration - Approximately 6 months
Participants are assessed for changes in motor and non-motor symptoms, physical fitness, pain-related outcomes, and other clinical measures 6 months after completing the exercise programme.
1 visit (in-person) at 6-month follow-up
Trial Site Locations
Total: 1 location
1
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain, 28922
Actively Recruiting
Research Team
M
Mario González Iglesias, MSc PhD Student, Physiotherapy
Y
Yeray González Zamorano, PhD, Physiotherapy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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