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

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

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.

Study Overview

• Status: Recruiting
• Conditions: PARKINSON DISEASE (Disorder)
• Intervention / Treatment: Other: Exercise Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario González Iglesias, MSc PhD Student, Physiotherapy; Phone Number: +34 622113365; Email: mario.gonzalez@urjc.es
• Study Contact Backup: Name: Yeray González Zamorano, PhD, Physiotherapy; Phone Number: +34 689105357; Email: yeray.gonzalez@urjc.es

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Recruiting
      • Universidad Rey Juan Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants from the control group will be asked to keep their usual treatment for the duration of the study.
Experimental: 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.	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 (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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At 12 weeks from Baseline
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)	At 39 weeks from Baseline
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)	At 12 weeks from Baseline
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)	At 39 weeks from Baseline
Change in Non-Motor Symptoms Scale (NMSS)	It is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions: 1) Cardiovascular, 2) Sleep/fatigue, 3) Mood/apathy, 4) Perceptual problems/hallucinations, 5) Attention/memory, 6) Gastrointestinal tract, 7) Urinary, 8) Sexual function and 9) Miscellaneous.	At a 12 weeks from Baseline
Change in Non-Motor Symptoms Scale (NMSS)	It is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions: 1) Cardiovascular, 2) Sleep/fatigue, 3) Mood/apathy, 4) Perceptual problems/hallucinations, 5) Attention/memory, 6) Gastrointestinal tract, 7) Urinary, 8) Sexual function and 9) Miscellaneous.	At a 39 weeks from Baseline
Change in 10 Repetition Maximum (10-RM)	The 10-RM is the maximum amount of weight a person can lift exactly 10 times with correct technique, without being able to perform an eleventh repetition. 10-RM for military press with dumbbells, lunges with dumbbells, deadlift with barbell and row with barbell will be assessed.	At 12 weeks from Baseline
Change in Isometric Handgrip Strength	A dynamometer is used to measure the maximum handgrip strength with both hands for three times. The mean is obtained after the three attempts.	At 12 weeks from Baseline
Change in Isometric Handgrip Strength	A dynamometer is used to measure the maximum handgrip strength with both hands for three times. The mean is obtained after the three attempts.	At 39 weeks from Baseline
Change in Dynamic Fatigability	A dynamometer is employed and the subject is asked to perform 15 consecutive maximum handgrip contractions.	At 12 weeks from Baseline
Change in Dynamic Fatigability	A dynamometer is employed and the subject is asked to perform 15 consecutive maximum handgrip contractions.	At 39 weeks from Baseline
Change in Five Times Sit to Stand Test	This test measures lower limbs power. The subject is asked to stand up and sit down on a chair as quicky as possible for five times while the therapist measures the time. Two attempts are performed to calculate the mean.	At 12 weeks from Baseline
Change in Five Times Sit to Stand Test	This test measures lower limbs power. The subject is asked to stand up and sit down on a chair as quicky as possible for five times while the therapist measures the time. Two attempts are performed to calculate the mean.	At 39 weeks from Baseline
Change in 6 Minute Walk Test	This test assesses the distance a person is capable to walk as fast as possible for 6 minutes.	At 12 weeks from Baseline
Change in 6 Minute Walk Test	This test assesses the distance a person is capable to walk as fast as possible for 6 minutes on a 15 metres long corridor.	At 39 weeks from Baseline
Change in Functional Movement Screen	This scale consists of seven motor tasks that measure the quality of movement in different body segments. Each task is scored from (worst score) 0 to 3 (best score).	At 12 weeks from Baseline
Change in King´s Parkinson´s Disease Pain Scale score	Parkinson´s Disease specific scale that evaluates the localization, frequency, and intensity of pain. It has 14 items distributed in 7 domains: 1. Musculoskeletal Pain; 2. Chronic Pain; 3. Fluctuation-related Pain; 4. Nocturnal Pain; 5. Oro-facial Pain; 6. Discoloration, Oedema/Swelling Pain; 7. Radicular Pain. Each item is scored by severity (0, none to 3, very severe) multiplied by frequency (0, never to 4, all the time) resulting in a subscore of 0 to 12, the sum of which gives the total score with a theoretical range from 0 to 168, with higher scores indicating more severity and frequency of pain.	At 12 weeks from Baseline
Change in King´s Parkinson´s Disease Pain Scale score	Parkinson´s Disease specific scale that evaluates the localization, frequency, and intensity of pain. It has 14 items distributed in 7 domains: 1. Musculoskeletal Pain; 2. Chronic Pain; 3. Fluctuation-related Pain; 4. Nocturnal Pain; 5. Oro-facial Pain; 6. Discoloration, Oedema/Swelling Pain; 7. Radicular Pain. Each item is scored by severity (0, none to 3, very severe) multiplied by frequency (0, never to 4, all the time) resulting in a subscore of 0 to 12, the sum of which gives the total score with a theoretical range from 0 to 168, with higher scores indicating more severity and frequency of pain.	At 39 weeks from Baseline
Change in Brief Pain Inventory	It assess the severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours.	At 12 weeks from Baseline
Change in Brief Pain Inventory	It assess the severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours.	At 39 weeks from Baseline
Change in Pressure Pain Threshold	Two Pain Pressure Thresholds will be measured by a handheld algometer, one over the most painful area (peripheric hyperalgesia) and the other one over the middle of the distal phalanx of the thumb (central hyperalgesia). The Pain Pressure Threshold will be applied with the algometer perpendicular to the skin increasing at a rate of 1 kg/s until the first sensation of pain. 3 measures with 30-seconds rest between them will be performed, taking the average as Pain Pressure Threshold.	At 12 weeks from Baseline
Change in Pressure Pain Threshold	Two Pain Pressure Thresholds will be measured by a handheld algometer, one over the most painful area (peripheric hyperalgesia) and the other one over the middle of the distal phalanx of the thumb (central hyperalgesia). The Pain Pressure Threshold will be applied with the algometer perpendicular to the skin increasing at a rate of 1 kg/s until the first sensation of pain. 3 measures with 30-seconds rest between them will be performed, taking the average as Pain Pressure Threshold.	At 39 weeks from Baseline
Change in Conditioned Pain Modulation	Assesses the descending pain modulatory system. The Pain Pressure Threshold will be assessed in the middle of the distal phalanx of the thumb with a handheld algometer, corresponding to the first test stimulus. Afterward, the patient will immerse the contrary hand up to the wrist into stirred ice-cold water (0-4º) maintaining it for 3 minutes corresponding to the conditioning stimulus. If the pain is unbearable before the 3 minutes, the patient will be able to remove his/her hand. Immediately after removing the hand, a second Pain Pressure Threshold measure will be performed in the same place as the first one, corresponding to the second test stimulus.	At 12 weeks from Baseline
Change in Conditioned Pain Modulation	Assesses the descending pain modulatory system. The Pain Pressure Threshold will be assessed in the middle of the distal phalanx of the thumb with a handheld algometer, corresponding to the first test stimulus. Afterward, the patient will immerse the contrary hand up to the wrist into stirred ice-cold water (0-4º) maintaining it for 3 minutes corresponding to the conditioning stimulus. If the pain is unbearable before the 3 minutes, the patient will be able to remove his/her hand. Immediately after removing the hand, a second Pain Pressure Threshold measure will be performed in the same place as the first one, corresponding to the second test stimulus.	At 39 weeks from Baseline
Change in Exercise-Induced Hypoalgesia	Exercise-Induced Hypoalgesia is a phenomenom in which pain sensitivity is reduced after a single bout of exercise. Pain sensitivity will be assessed before and immediately after the 6 minute walk test. Pain sensitivity will be measured with a handheld algometer on the dominant quadriceps and on the non-dominant trapezius for two times. The algometer will be placed perpendicular to the skin increasing at a rate of 1 kg/s until the first sensation of pain.	At 12 weeks from Baseline
Change in Exercise-Induced Hypoalgesia	Exercise-Induced Hypoalgesia is a phenomenom in which pain sensitivity is reduced after a single bout of exercise. Pain sensitivity will be assessed before and immediately after the 6 minute walk test. Pain sensitivity will be measured with a handheld algometer on the dominant quadriceps and on the non-dominant trapezius for two times. The algometer will be placed perpendicular to the skin increasing at a rate of 1 kg/s until the first sensation of pain.	At 39 weeks from Baseline
Change in Tampa Scale of Kinesiophobia	Measures fear of movement-related pain. Its scores range from 11-44 points with higher scores indicating greater fear of pain, movement, and injury	At 12 weeks from Baseline
Change in Tampa Scale of Kinesiophobia	Measures fear of movement-related pain. Its scores range from 11-44 points with higher scores indicating greater fear of pain, movement, and injury	At 39 weeks from Baseline
Pain Catastrophizing Scale	Measures catastrophizing thinking. Its total score range from 0-52, along with three subscale scores assessing rumination, magnification and helplessness, with higher scores indicating higher level of catastrophizing.	At 12 weeks from Baseline
Pain Catastrophizing Scale	Measures catastrophizing thinking. Its total score range from 0-52, along with three subscale scores assessing rumination, magnification and helplessness, with higher scores indicating higher level of catastrophizing.	At 39 weeks from Baseline
Change In Fatigue Severity Scale	It is a validated 9-item scale for PD that measures the long-term functional impact of fatigue. Each item is scored from 1 (Disagree) to 7 (Agree).	At 12 weeks from Baseline
Change In Fatigue Severity Scale	It is a validated 9-item scale for PD that measures the long-term functional impact of fatigue. Each item is scored from 1 (Disagree) to 7 (Agree).	At 39 weeks from Baseline
Change in Parkinson's Disease Sleep Scale 2 (PDSS-2)	This scale contains 15 items that measures the level of sleep disruption. The questionnaire asks about the frequency of the sleep disturbances from "never" to "very often".	At 12 weeks from Baseline
Change in Parkinson's Disease Sleep Scale 2 (PDSS-2)	This scale contains 15 items that measures the level of sleep disruption. The questionnaire asks about the frequency of the sleep disturbances from "never" to "very often".	At 39 weeks from Baseline
Change in State-Trait Anxiety Inventory	Measures anxious states and anxious traits. It has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.	At 12 weeks from Baseline
Change in State-Trait Anxiety Inventory	Measures anxious states and anxious traits. It has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.	At 39 weeks from Baseline
Change in Beck Depression Inventory	Measures depressive symptoms. Scores range from 0 to 63 leading to 6 groups: 0-10, normal; 11-16, mild mood disturbance; 17-20, borderline clinical depression; 21-30, moderate depression; 31-40, severe depression; and over 40, extreme depression.	At 12 weeks from Baseline
Change in Beck Depression Inventory	Measures depressive symptoms. Scores range from 0 to 63 leading to 6 groups: 0-10, normal; 11-16, mild mood disturbance; 17-20, borderline clinical depression; 21-30, moderate depression; 31-40, severe depression; and over 40, extreme depression.	At 39 weeks from Baseline
Change in Global Physical Activity Questionnaire (GPAQ)	It is a questionnaire that consists of 15 questions about physical activity at work, during commutes and in leisure time, and an additional question about sedentary behaviour during a typical week. This questionnaire provides a numerical result in METs, such that the more active the person is, the more METs the instrument reflects.	At 12 weeks from Baseline
Change in Global Physical Activity Questionnaire (GPAQ)	It is a questionnaire that consists of 15 questions about physical activity at work, during commutes and in leisure time, and an additional question about sedentary behaviour during a typical week. This questionnaire provides a numerical result in METs, such that the more active the person is, the more METs the instrument reflects.	At 39 weeks from Baseline

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Collaborators: Asociación Parkinson Madrid
• Investigators: Principal Investigator: Mario González Iglesias, Physiotherapy, Universidad Rey Juan Carlos

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Martinez-Martin P, Rodriguez-Blazquez C, Kurtis MM, Chaudhuri KR; NMSS Validation Group. The impact of non-motor symptoms on health-related quality of life of patients with Parkinson's disease. Mov Disord. 2011 Feb 15;26(3):399-406. doi: 10.1002/mds.23462. Epub 2011 Jan 24.
• Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28.
• 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.
• 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.
• 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.
• Kouli A, Torsney KM, Kuan WL. Parkinson's Disease: Etiology, Neuropathology, and Pathogenesis. In: Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Chapter 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK536722/
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: May 25, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Parkinson's Disease; Non-motor symptoms; Motor symptoms; Multimodal; Exercise programme; Individualised
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 090420253882025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual anonymized participant data will be available to other researchers under request.
• IPD Sharing Time Frame: Six months at the end of the study.
• IPD Sharing Access Criteria: Individual anonymized participant data will be available to other researchers under request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No