PARKINSON DISEASE (Disorder)NCT07618728
Feasibility of a Community-Based Multimodal Exercise Programme in Parkinson's Disease
A study testing Exercise Group in people with PARKINSON DISEASE (Disorder), run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 8 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mario González Iglesias, MSc PhD Student, Physiotherapy contact
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
About this study
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
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.
Read the 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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Exercise Group
- Keywords
- Parkinson's Disease, Exercise programme, Feasibility, Multimodal, Individualised, Motor symptoms, Non-motor symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise GroupOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate
It will be asessed as the proportion of individuals who provided informed consent relative to the number of individuals invited to participate
Measured: Baseline
Recruitment rate
It will be evaluated as the proportion of enrolled participants relative to the number of eligible participants screened
Measured: Baseline
Adherence rate
Adherence rate will be assessed as the proportion of completed sessions relative to the scheduled sessions
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Through study completion (average across 12 weeks)
Secondary outcomes (40)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 39 weeks from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start8 Sep 2025
- Primary completion29 May 2026
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Parkinson Madrid
- Responsible party
- Principal investigator, Mario González Iglesias, Universidad Rey Juan Carlos
- Investigators
- Mario González Iglesias, Physiotherapy, Principal investigator, Universidad Rey Juan CarlosJavier Güeita Rodríguez, Physiotherapy, Study director, Universidad Rey Juan CarlosYeray González Zamorano, Physiotherapy, Study director, Universidad Rey Juan CarlosJuan Pablo Romero Muñoz, MD, Study director, Universidad Francisco de VitoriaJosué Fernández Carnero, Physiotherapy, Study director, Universidad Rey Juan CarlosAlberto Arribas Romano, Physiotherapy, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618728
- Sponsor's protocol ID
- 090420253882025
- Status last verified
- Sep 2026
- First submitted
- 25 May 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymized participant data will be available to other researchers under request.
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.
PubMed 25609935GBD 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.
PubMed 30879893Aschbrenner 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.
PubMed 36163045Danoudis 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.
PubMed 34546146Morris 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.
PubMed 28342682King 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.
PubMed 23738230Ashburn 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.
PubMed 17119004Feng 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.
PubMed 31165721Avenali 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.
PubMed 33978924Reuter 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.
PubMed 21603199Gobbi 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.
PubMed 32561505Ernst 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.
PubMed 38588457Mylius 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.
PubMed 33044395Silverdale 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.
PubMed 29903584Broen 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.
PubMed 22231908
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07618728
- Acronym / sponsor ID
- 090420253882025
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Parkinson's Disease, Exercise programme, Feasibility, Multimodal, Individualised, Motor symptoms, Non-motor symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Asociación Parkinson Madrid
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise GroupTwo 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. |
| Control Group | No intervention | –Participants from the control group will be asked to keep their usual treatment for the duration of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise GroupIn-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 | Other | Exercise group |
Primary outcome
Consent rate
Time frame: 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
Time frame: Baseline
It will be evaluated as the proportion of enrolled participants relative to the number of eligible participants screened
Adherence rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
40 secondary outcomes
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
Change in Five Times Sit to Stand Test
Time frame: At 39 weeks from Baseline
Change in 6 Minute Walk Test
Time frame: At 12 weeks from Baseline
Change in 6 Minute Walk Test
Time frame: At 39 weeks from Baseline
Change in Functional Movement Screen
Time frame: At 12 weeks from Baseline
Change in King´s Parkinson´s Disease Pain Scale score
Time frame: At 12 weeks from Baseline
Change in King´s Parkinson´s Disease Pain Scale score
Time frame: At 39 weeks from Baseline
Change in Brief Pain Inventory
Time frame: At 12 weeks from Baseline
Change in Brief Pain Inventory
Time frame: At 39 weeks from Baseline
Change in Pressure Pain Threshold
Time frame: At 12 weeks from Baseline
Change in Pressure Pain Threshold
Time frame: At 39 weeks from Baseline
Change in Conditioned Pain Modulation
Time frame: At 12 weeks from Baseline
Change in Conditioned Pain Modulation
Time frame: At 39 weeks from Baseline
Change in Exercise-Induced Hypoalgesia
Time frame: At 12 weeks from Baseline
Change in Exercise-Induced Hypoalgesia
Time frame: At 39 weeks from Baseline
Change in Tampa Scale of Kinesiophobia
Time frame: At 12 weeks from Baseline
Change in Tampa Scale of Kinesiophobia
Time frame: At 39 weeks from Baseline
Pain Catastrophizing Scale
Time frame: At 12 weeks from Baseline
Pain Catastrophizing Scale
Time frame: At 39 weeks from Baseline
Change In Fatigue Severity Scale
Time frame: At 12 weeks from Baseline
Change In Fatigue Severity Scale
Time frame: At 39 weeks from Baseline
Change in Parkinson's Disease Sleep Scale 2 (PDSS-2)
Time frame: At 12 weeks from Baseline
Change in Parkinson's Disease Sleep Scale 2 (PDSS-2)
Time frame: At 39 weeks from Baseline
Change in State-Trait Anxiety Inventory
Time frame: At 12 weeks from Baseline
Change in State-Trait Anxiety Inventory
Time frame: At 39 weeks from Baseline
Change in Beck Depression Inventory
Time frame: At 12 weeks from Baseline
Change in Beck Depression Inventory
Time frame: At 39 weeks from Baseline
Change in Global Physical Activity Questionnaire (GPAQ)
Time frame: At 12 weeks from Baseline
Change in Global Physical Activity Questionnaire (GPAQ)
Time frame: At 39 weeks from Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 25609935Carvalho 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.
- Background: PubMed 30879893GBD 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.
- Background: PubMed 36163045Aschbrenner 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.
- Background: PubMed 34546146Danoudis 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.
- Background: PubMed 28342682Morris 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.
- Background: PubMed 23738230King 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.
- Background: PubMed 17119004Ashburn 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.
- Background: PubMed 31165721Feng 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.
- Background: PubMed 33978924Avenali 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.
- Background: PubMed 21603199Reuter 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.
- Background: PubMed 32561505Gobbi 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.
- Background: PubMed 38588457Ernst 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.
- Individual participant dataSharing planned: Yes. Individual anonymized participant data will be available to other researchers under request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario González Iglesias, MSc PhD Student, Physiotherapy contact
Mario González Iglesias, Physiotherapy principal investigator
Universidad Rey Juan Carlos
Javier Güeita Rodríguez, Physiotherapy study director
Universidad Rey Juan Carlos
Yeray González Zamorano, Physiotherapy study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Group in people with PARKINSON DISEASE (Disorder), run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario González Iglesias, MSc PhD Student, Physiotherapy (622 113 365 ext. +34, mario.gonzalez@urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consent rate (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07618728, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 2 Nov 2026.