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

Official title

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

Overview

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.

Detailed description

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.

Frequency matching will be used at the group level according to sex, 10-year age categories and Hoehn \& Yahr stage categories (1-1.5, 2-2.5 and 3). Individual 1:1 matching will not be required. This approach was selected to reduce baseline imbalance while maintaining the feasibility of recruitment within a real-world community setting.

The sample size was determined according to the primary feasibility objective, specifically the precision of the estimated adherence rate. Assuming an expected adherence rate of approximately 80%, 28 participants would provide an estimation precision of approximately ±15% with a 95% confidence interval. Considering potential attrition, the intervention group sample size was increased to 32 participants. A matched non-exercise control group of 32 participants will also be recruited, resulting in a total target sample size of 64 participants.

Participants with Hoehn \& Yahr stages 1-3 will be recruited from Asociación Parkinson Madrid and other Parkinson's disease associations in the Madrid region.

The intervention group will participate in a 12-week multimodal exercise programme consisting of two weekly supervised face-to-face sessions and one weekly home-based session. The programme includes strength training, cardiovascular/balance exercise and cognitive-motor exercises. Exercise prescription and progression were individualised according to participant tolerance, functional capacity, motor performance, and safety considerations.

Training intensity was monitored and adjusted using 10-repetition maximum principles, repetitions in reserve (RIR), and perceived exertion scales including OMNI-RES and Borg ratings. Exercise prescription and progression were individualised according to participant tolerance, functional capacity, motor performance, and safety considerations. All supervised sessions were delivered by physiotherapists experienced in neurological rehabilitation and exercise prescription for Parkinson's disease.

Outcomes will be assessed at baseline, post-intervention and 6-month follow-up.

Feasibility outcomes will be analysed descriptively using frequencies, percentages, means and confidence intervals where appropriate. Secondary clinical outcomes measured at baseline, post-intervention and 6-month follow-up will be analysed using linear mixed-effects models including group, time and group-by-time interaction effects. Estimated between-group differences, 95% confidence intervals and effect sizes will be reported. Given the feasibility nature of the study and the non-randomized sequential design, efficacy analyses will be interpreted as exploratory and hypothesis-generating rather than confirmatory.

Interventions

• Other 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

Primary outcome measures

• Consent rate [Time frame: Baseline]
• Recruitment rate [Time frame: Baseline]
• Adherence rate [Time frame: Post-intervention (At 12 weeks from the start of the programme)]
• Intervention completion rate [Time frame: Post-intervention (At 12 weeks from the start of the programme)]
• Trial completion rate [Time frame: At 39 weeks from the start of the programme]
• Proportion of adverse events [Time frame: Post-intervention (At 12 weeks from the start of the programme)]
• Treatment-decision rate [Time frame: Post-intervention (At 12 weeks from the start of the programme)]
• Change in Theoretical Framework Acceptability Questionnaire [Time frame: At 12 weeks from Baseline]
• Client Satisfaction Questionnaire (CSQ-8) [Time frame: Post-intervention (12 weeks from baseline)]
• Average Rating of Perceived Exertion (RPE) during Resistance Training [Time frame: Through study completion (average across 12 weeks)]

Secondary outcome measures (12)

• Change in Unified Parkinson Disease Rating Scale Part 3 (UPDRS-3) [Time frame: At 12 weeks from Baseline]
• Change in Unified Parkinson Disease Rating Scale Part 3 (UPDRS-3) [Time frame: At 39 weeks from Baseline]
• Change in Balance Berg Scale [Time frame: At 12 weeks from Baseline]
• Change in Balance Berg Scale [Time frame: At 39 weeks from Baseline]
• Change in Non-Motor Symptoms Scale (NMSS) [Time frame: At a 12 weeks from Baseline]
• Change in Non-Motor Symptoms Scale (NMSS) [Time frame: At a 39 weeks from Baseline]
• Change in 10 Repetition Maximum (10-RM) [Time frame: At 12 weeks from Baseline]
• Change in Isometric Handgrip Strength [Time frame: At 12 weeks from Baseline]
• Change in Isometric Handgrip Strength [Time frame: At 39 weeks from Baseline]
• Change in Dynamic Fatigability [Time frame: At 12 weeks from Baseline]
• Change in Dynamic Fatigability [Time frame: At 39 weeks from Baseline]
• Change in Five Times Sit to Stand Test [Time frame: At 12 weeks from Baseline]

Eligibility criteria

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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Universidad Rey Juan Carlos — Alcorcón

Publications

• Carvalho A, Barbirato D, Araujo N, Martins JV, Cavalcanti JL, Santos TM, Coutinho ES, Laks J, Deslandes AC. Comparison of strength training, aerobic training, and additional physical therapy as supplementary treatments for Parkinson's disease: pilot study. Clin Interv Aging. 2015 Jan 7;10:183-91. doi: 10.2147/CIA.S68779. eCollection 2015. PMID 25609935
• GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14. PMID 30879893
• Aschbrenner KA, Kruse G, Gallo JJ, Plano Clark VL. Applying mixed methods to pilot feasibility studies to inform intervention trials. Pilot Feasibility Stud. 2022 Sep 26;8(1):217. doi: 10.1186/s40814-022-01178-x. PMID 36163045
• Danoudis M, Iansek R. A long-term community gym program for people with Parkinson's disease: a feasibility study of the Monash Health "Health and Fitness" model. Disabil Rehabil. 2022 Nov;44(23):7330-7338. doi: 10.1080/09638288.2021.1977396. Epub 2021 Sep 21. PMID 34546146
• Morris ME, Taylor NF, Watts JJ, Evans A, Horne M, Kempster P, Danoudis M, McGinley J, Martin C, Menz HB. A home program of strength training, movement strategy training and education did not prevent falls in people with Parkinson's disease: a randomised trial. J Physiother. 2017 Apr;63(2):94-100. doi: 10.1016/j.jphys.2017.02.015. Epub 2017 Mar 14. PMID 28342682
• King LA, Salarian A, Mancini M, Priest KC, Nutt J, Serdar A, Wilhelm J, Schlimgen J, Smith M, Horak FB. Exploring outcome measures for exercise intervention in people with Parkinson's disease. Parkinsons Dis. 2013;2013:572134. doi: 10.1155/2013/572134. Epub 2013 Apr 30. PMID 23738230
• Ashburn A, Fazakarley L, Ballinger C, Pickering R, McLellan LD, Fitton C. A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):678-84. doi: 10.1136/jnnp.2006.099333. Epub 2006 Nov 21. PMID 17119004
• Feng H, Li C, Liu J, Wang L, Ma J, Li G, Gan L, Shang X, Wu Z. Virtual Reality Rehabilitation Versus Conventional Physical Therapy for Improving Balance and Gait in Parkinson's Disease Patients: A Randomized Controlled Trial. Med Sci Monit. 2019 Jun 5;25:4186-4192. doi: 10.12659/MSM.916455. PMID 31165721

Identifiers

NCT: NCT07618728 · 090420253882025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗