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.
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.
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.
Sequential
Exercise Group
Other interventionIn-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
Consent rate
It will be asessed as the proportion of individuals who provided informed consent relative to the number of individuals invited to participate
Recruitment rate
It will be evaluated as the proportion of enrolled participants relative to the number of eligible participants screened
Adherence rate
Adherence rate will be assessed as the proportion of completed sessions relative to the scheduled sessions
Intervention completion rate
It will be evaluated as the proportion of participants who completed at least 80% of sessions.
Change in Unified Parkinson Disease Rating Scale Part 3 (UPDRS-3)
This scale evaluates the severity of those motor symptoms linked to the disease such as tremor, rigidity, bradikinesia, postural instability and gait distubances. It consists of 18 items that are scored from 0 (no disturbance) to 4 (maximum disturbance)
Change in Unified Parkinson Disease Rating Scale Part 3 (UPDRS-3)
This scale evaluates the severity of those motor symptoms linked to the disease such as tremor, rigidity, bradikinesia, postural instability and gait distubances. It consists of 18 items that are scored from 0 (no disturbance) to 4 (maximum disturbance)
Change in Balance Berg Scale
This scale measures static and dynamic balance through 14 tasks. Each task is scored from 0 (worst score) to 4 (best score)
Change in Balance Berg Scale
This scale measures static and dynamic balance through 14 tasks. Each task is scored from 0 (worst score) to 4 (best score)
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Universidad Rey Juan Carlos
Lead sponsor
Asociación Parkinson Madrid
Collaborator
