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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain
RECRUITINGConsent rate
It will be asessed as the proportion of individuals who provided informed consent relative to the number of individuals invited to participate
Time frame: Baseline
Recruitment rate
It will be evaluated as the proportion of enrolled participants relative to the number of eligible participants screened
Time frame: Baseline
Adherence rate
Adherence rate will be assessed as the proportion of completed sessions relative to the scheduled sessions
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Through study completion (average across 12 weeks)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 39 weeks from Baseline