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

NCT07618728 | Recruiting

• 1 other identifier: 090420253882025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinson's Disease; Exercise programme; Feasibility; Multimodal; Individualised; Motor symptoms; Non-motor symptoms

Outcome Measures

Primary Outcomes (11)

• Consent rate

  It will be asessed as the proportion of individuals who provided informed consent relative to the number of individuals invited to participate

  Baseline

• Recruitment rate

  It will be evaluated as the proportion of enrolled participants relative to the number of eligible participants screened

  Baseline

• Adherence rate

  Adherence rate will be assessed as the proportion of completed sessions relative to the scheduled sessions

  Post-intervention (At 12 weeks from the start of the programme)

• Intervention completion rate

  It will be evaluated as the proportion of participants who completed at least 80% of sessions.

  Post-intervention (At 12 weeks from the start of the programme)

• Trial completion rate

  It will be assessed as the proportion of participants who completed all assessments

  At 39 weeks from the start of the programme

• Proportion of adverse events

  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)

  Post-intervention (At 12 weeks from the start of the programme)

• Treatment-decision rate

  Defined as the proportion of exercises that required modification due to fall-risk considerations

  Post-intervention (At 12 weeks from the start of the programme)

• Change in Theoretical Framework Acceptability Questionnaire

  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.

  At 12 weeks from Baseline

• Client Satisfaction Questionnaire (CSQ-8)

  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.

  Post-intervention (12 weeks from baseline)

• Average Rating of Perceived Exertion (RPE) during Resistance Training

  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

  Through study completion (average across 12 weeks)

• Average Rating of Perceived Exertion (RPE) during Cardiorespiratory Exercise

  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.

  Through study completion (average across 12 weeks)

Secondary Outcomes (40)

• 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

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Other: Exercise Group

Control Group

NO INTERVENTION

Participants from the control group will be asked to keep their usual treatment for the duration of the study.

Interventions

Exercise Group OTHER

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

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead
• Asociación Parkinson Madrid: collaborator

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

RECRUITING

Related Publications (20)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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• Avenali M, Picascia M, Tassorelli C, Sinforiani E, Bernini S. Evaluation of the efficacy of physical therapy on cognitive decline at 6-month follow-up in Parkinson disease patients with mild cognitive impairment: a randomized controlled trial. Aging Clin Exp Res. 2021 Dec;33(12):3275-3284. doi: 10.1007/s40520-021-01865-4. Epub 2021 May 12.

  PMID: 33978924 BACKGROUND

• Reuter I, Mehnert S, Leone P, Kaps M, Oechsner M, Engelhardt M. Effects of a flexibility and relaxation programme, walking, and nordic walking on Parkinson's disease. J Aging Res. 2011;2011:232473. doi: 10.4061/2011/232473. Epub 2011 Mar 30.

  PMID: 21603199 BACKGROUND

• Gobbi LTB, Pelicioni PHS, Lahr J, Lirani-Silva E, Teixeira-Arroyo C, Santos PCRD. Effect of different types of exercises on psychological and cognitive features in people with Parkinson's disease: A randomized controlled trial. Ann Phys Rehabil Med. 2021 Jan;64(1):101407. doi: 10.1016/j.rehab.2020.05.011. Epub 2020 Oct 6.

  PMID: 32561505 BACKGROUND

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 BACKGROUND

• Mylius V, Perez Lloret S, Cury RG, Teixeira MJ, Barbosa VR, Barbosa ER, Moreira LI, Listik C, Fernandes AM, de Lacerda Veiga D, Barbour J, Hollenstein N, Oechsner M, Walch J, Brugger F, Hagele-Link S, Beer S, Rizos A, Chaudhuri KR, Bouhassira D, Lefaucheur JP, Timmermann L, Gonzenbach R, Kagi G, Moller JC, Ciampi de Andrade D. The Parkinson disease pain classification system: results from an international mechanism-based classification approach. Pain. 2021 Apr 1;162(4):1201-1210. doi: 10.1097/j.pain.0000000000002107.

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• Silverdale MA, Kobylecki C, Kass-Iliyya L, Martinez-Martin P, Lawton M, Cotterill S, Chaudhuri KR, Morris H, Baig F, Williams N, Hubbard L, Hu MT, Grosset DG; UK Parkinson's Pain Study Collaboration. A detailed clinical study of pain in 1957 participants with early/moderate Parkinson's disease. Parkinsonism Relat Disord. 2018 Nov;56:27-32. doi: 10.1016/j.parkreldis.2018.06.001. Epub 2018 Jun 6.

  PMID: 29903584 BACKGROUND

• Broen MP, Braaksma MM, Patijn J, Weber WE. Prevalence of pain in Parkinson's disease: a systematic review using the modified QUADAS tool. Mov Disord. 2012 Apr;27(4):480-4. doi: 10.1002/mds.24054. Epub 2012 Jan 9.

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• Barone P, Antonini A, Colosimo C, Marconi R, Morgante L, Avarello TP, Bottacchi E, Cannas A, Ceravolo G, Ceravolo R, Cicarelli G, Gaglio RM, Giglia RM, Iemolo F, Manfredi M, Meco G, Nicoletti A, Pederzoli M, Petrone A, Pisani A, Pontieri FE, Quatrale R, Ramat S, Scala R, Volpe G, Zappulla S, Bentivoglio AR, Stocchi F, Trianni G, Dotto PD; PRIAMO study group. The PRIAMO study: A multicenter assessment of nonmotor symptoms and their impact on quality of life in Parkinson's disease. Mov Disord. 2009 Aug 15;24(11):1641-9. doi: 10.1002/mds.22643.

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• Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.

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MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mario González Iglesias, Physiotherapy

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario González Iglesias, MSc PhD Student, Physiotherapy

CONTACT

+34 622113365; mario.gonzalez@urjc.es

Yeray González Zamorano, PhD, Physiotherapy

CONTACT

+34 689105357; yeray.gonzalez@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PhD Student

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: September 8, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Six months at the end of the study.
• Access Criteria: Individual anonymized participant data will be available to other researchers under request.

Locations

ES (1)