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

Condition(s) studied

Investigational drug(s) / intervention(s)

Exercise Group: 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

Study 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

Primary outcome measure(s)

• Consent rate — Baseline
  It will be asessed as the proportion of individuals who provided informed consent relative to the number of individuals invited to participate
• Recruitment rate — Baseline
  It will be evaluated as the proportion of enrolled participants relative to the number of eligible participants screened
• Adherence rate — Post-intervention (At 12 weeks from the start of the programme)
  Adherence rate will be assessed as the proportion of completed sessions relative to the scheduled sessions
• Intervention completion rate — Post-intervention (At 12 weeks from the start of the programme)
  It will be evaluated as the proportion of participants who completed at least 80% of sessions.
• Trial completion rate — At 39 weeks from the start of the programme
  It will be assessed as the proportion of participants who completed all assessments
• Proportion of adverse events — Post-intervention (At 12 weeks from the start of the programme)
  Safety will be reported as the proportion of adverse events, defined as the proportion of participants who experienced adverse events (e.g., falls, pain, fatigue)
• Treatment-decision rate — Post-intervention (At 12 weeks from the start of the programme)
  Defined as the proportion of exercises that required modification due to fall-risk considerations
• Change in Theoretical Framework Acceptability Questionnaire — At 12 weeks from Baseline
  It is a questionnaire specifically desgined to assess acceptability of healthcare interventions. It consists of 7 domains: 1) Affective attitude, 2) Burden, 3) Ethicality, 4)Perceived efectiveness, 5) Intervention coherence, 6) Self efficacy, 7) Opportinity costs 8) General acceptability.
• Client Satisfaction Questionnaire (CSQ-8) — Post-intervention (12 weeks from baseline)
  It contains 8 dimensions measuring satisfaction with the care and treatment received. The total score is 32 points, with higher scores indicating greater satisfaction. Dimensions related to satisfaction with the training modality and tool used (entertainment, ease of use, accessibility, among others), the professional who applies it (clear explanation, availability, ability to adapt, among others) or recommendation to other patients will be evaluated.
• Average Rating of Perceived Exertion (RPE) during Resistance Training — Through study completion (average across 12 weeks)
  The average perceived effort reported by the participants across all strength training sessions over the 12-week intervention. This will be assessed using the OMNI-Resistance Exercise Scale (OMNI-RES), which ranges from 0 ("extremely easy") to 10 ("extremely hard"). Higher scores indicate a greater perception of effort during the execution of strength exercises
• Average Rating of Perceived Exertion (RPE) during Cardiorespiratory Exercise — Through study completion (average across 12 weeks)
  The average intensity of effort perceived by the participants during all cardiorespiratory training sessions. This will be measured using the Borg Rating of Perceived Exertion (RPE) 6-20 Scale. The scale ranges from 6 (no exertion at all) to 20 (maximal exertion). This metric reflects the global subjective strain experienced during aerobic activities throughout the 12-week program.

Trial sites (1)

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