Feasibility and Preliminary Effectiveness of an Individualised Multimodal Group-Based Exercise Programme for People With Parkinson's Disease: A Non-Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Consent rate
研究概览
简要总结
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.
详细描述
Parkinson's disease (PD) is a chronic and progressive neurodegenerative disorder characterised by motor symptoms such as bradykinesia, rigidity and tremor, as well as non-motor symptoms including pain, fatigue, sleep disturbances, cognitive impairment and psychiatric symptoms. Although pharmacological management is effective for several motor manifestations, many non-motor symptoms respond poorly to dopaminergic therapy, highlighting the need for complementary non-pharmacological interventions.
Exercise therapy has shown beneficial effects on both motor and non-motor symptoms in people with Parkinson's disease. However, it remains necessary to determine whether exercise programmes supported by the scientific literature can be feasibly implemented within real-world community environments frequently attended by patients, such as Parkinson's disease associations. In these settings, exercise interventions are commonly delivered in generic group-based formats despite the substantial heterogeneity in symptom severity, functional capacity and disease progression among participants. Therefore, there is also a need to design exercise programmes that allow individualised adjustment of exercise prescription parameters, including intensity and progression criteria, in order to optimize the potential effects of exercise on Parkinson's disease symptoms while maintaining safety and feasibility in community-based group settings.
The present study aims to evaluate the feasibility of implementing a multimodal, group-based but individualised therapeutic exercise programme within a real-world Parkinson's disease association setting. Feasibility outcomes include consent and recruitment rates, adherence, intervention completion, trial completion, acceptability, perceived exertion, treatment-decision rate and safety. Control group recruitment and assessment completion will be reported descriptively as operational information related to the exploratory comparison group, but they will not determine the primary feasibility assessment of the intervention.
Secondary objectives are to obtain preliminary comparative information regarding the potential effectiveness of the intervention on motor and non-motor symptoms, gait, balance, physical fitness, pain-related outcomes and exercise-induced hypoalgesia.
This study uses a non-randomized sequential feasibility design. Recruitment of the intervention group as a cohort was necessary to implement the group exercise programme under realistic conditions and to evaluate intervention-related feasibility outcomes. To provide preliminary comparative information regarding effectiveness, a matched non-exercise control group was included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Exercise Group (Other)
Control Group
Participants from the control group will be asked to keep their usual treatment for the duration of the study.
结局指标
主要结局
Consent rate
时间窗: 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
时间窗: Baseline
It will be evaluated as the proportion of enrolled participants relative to the number of eligible participants screened
Adherence rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in Unified Parkinson Disease Rating Scale Part 3 (UPDRS-3)(At 12 weeks from Baseline)
- Change in Unified Parkinson Disease Rating Scale Part 3 (UPDRS-3)(At 39 weeks from Baseline)
- Change in Balance Berg Scale(At 12 weeks from Baseline)
- Change in Balance Berg Scale(At 39 weeks from Baseline)
- Change in Non-Motor Symptoms Scale (NMSS)(At a 12 weeks from Baseline)
- Change in Non-Motor Symptoms Scale (NMSS)(At a 39 weeks from Baseline)
- Change in 10 Repetition Maximum (10-RM)(At 12 weeks from Baseline)
- Change in Isometric Handgrip Strength(At 12 weeks from Baseline)
- Change in Isometric Handgrip Strength(At 39 weeks from Baseline)
- Change in Dynamic Fatigability(At 12 weeks from Baseline)
- Change in Dynamic Fatigability(At 39 weeks from Baseline)
- Change in Five Times Sit to Stand Test(At 12 weeks from Baseline)
- Change in Five Times Sit to Stand Test(At 39 weeks from Baseline)
- Change in 6 Minute Walk Test(At 12 weeks from Baseline)
- Change in 6 Minute Walk Test(At 39 weeks from Baseline)
- Change in Functional Movement Screen(At 12 weeks from Baseline)
- Change in King´s Parkinson´s Disease Pain Scale score(At 12 weeks from Baseline)
- Change in King´s Parkinson´s Disease Pain Scale score(At 39 weeks from Baseline)
- Change in Brief Pain Inventory(At 12 weeks from Baseline)
- Change in Brief Pain Inventory(At 39 weeks from Baseline)
- Change in Pressure Pain Threshold(At 12 weeks from Baseline)
- Change in Pressure Pain Threshold(At 39 weeks from Baseline)
- Change in Tampa Scale of Kinesiophobia(At 12 weeks from Baseline)
- Change in Tampa Scale of Kinesiophobia(At 39 weeks from Baseline)
- Change in Conditioned Pain Modulation(At 12 weeks from Baseline)
- Change in Conditioned Pain Modulation(At 39 weeks from Baseline)
- Change in Exercise-Induced Hypoalgesia(At 12 weeks from Baseline)
- Change in Exercise-Induced Hypoalgesia(At 39 weeks from Baseline)
- Pain Catastrophizing Scale(At 12 weeks from Baseline)
- Pain Catastrophizing Scale(At 39 weeks from Baseline)
- Change In Fatigue Severity Scale(At 12 weeks from Baseline)
- Change In Fatigue Severity Scale(At 39 weeks from Baseline)
- Change in Parkinson's Disease Sleep Scale 2 (PDSS-2)(At 12 weeks from Baseline)
- Change in Parkinson's Disease Sleep Scale 2 (PDSS-2)(At 39 weeks from Baseline)
- Change in State-Trait Anxiety Inventory(At 12 weeks from Baseline)
- Change in State-Trait Anxiety Inventory(At 39 weeks from Baseline)
- Change in Beck Depression Inventory(At 12 weeks from Baseline)
- Change in Beck Depression Inventory(At 39 weeks from Baseline)
- Change in Global Physical Activity Questionnaire (GPAQ)(At 12 weeks from Baseline)
- Change in Global Physical Activity Questionnaire (GPAQ)(At 39 weeks from Baseline)
研究者
Mario González Iglesias
MSc, PhD Student
Universidad Rey Juan Carlos