PARKINSON DISEASE (Disorder)
Conditions
Keywords
Parkinson's Disease, Exercise programme, Feasibility, Multimodal, Individualised, Motor symptoms, Non-motor symptoms
Brief summary
This study aims to evaluate the feasibility and preliminary effectiveness of a multimodal, group-based but individualised therapeutic exercise programme for people with Parkinson's disease delivered within a real-world community-based patient association setting. The primary objective is to assess the feasibility of implementing the programme, including recruitment, consent, adherence, intervention completion, acceptability, perceived exertion and safety. Secondary objectives are to obtain preliminary comparative information regarding the effects of the intervention on motor and non-motor symptoms, physical fitness, pain-related outcomes and exercise-induced hypoalgesia. This is a non-randomized sequential feasibility study including an intervention group participating in a 12-week multimodal exercise programme and a matched non-exercise control group maintaining usual activities. Outcomes will be assessed at baseline, post-intervention and 6-month follow-up.
Detailed description
Parkinson's disease (PD) is a chronic and progressive neurodegenerative disorder characterised by motor symptoms such as bradykinesia, rigidity and tremor, as well as non-motor symptoms including pain, fatigue, sleep disturbances, cognitive impairment and psychiatric symptoms. Although pharmacological management is effective for several motor manifestations, many non-motor symptoms respond poorly to dopaminergic therapy, highlighting the need for complementary non-pharmacological interventions. Exercise therapy has shown beneficial effects on both motor and non-motor symptoms in people with Parkinson's disease. However, it remains necessary to determine whether exercise programmes supported by the scientific literature can be feasibly implemented within real-world community environments frequently attended by patients, such as Parkinson's disease associations. In these settings, exercise interventions are commonly delivered in generic group-based formats despite the substantial heterogeneity in symptom severity, functional capacity and disease progression among participants. Therefore, there is also a need to design exercise programmes that allow individualised adjustment of exercise prescription parameters, including intensity and progression criteria, in order to optimize the potential effects of exercise on Parkinson's disease symptoms while maintaining safety and feasibility in community-based group settings. The present study aims to evaluate the feasibility of implementing a multimodal, group-based but individualised therapeutic exercise programme within a real-world Parkinson's disease association setting. Feasibility outcomes include consent and recruitment rates, adherence, intervention completion, trial completion, acceptability, perceived exertion, treatment-decision rate and safety. Control group recruitment and assessment completion will be reported descriptively as operational information related to the exploratory comparison group, but they will not determine the primary feasibility assessment of the intervention. Secondary objectives are to obtain preliminary comparative information regarding the potential effectiveness of the intervention on motor and non-motor symptoms, gait, balance, physical fitness, pain-related outcomes and exercise-induced hypoalgesia. This study uses a non-randomized sequential feasibility design. Recruitment of the intervention group as a cohort was necessary to implement the group exercise programme under realistic conditions and to evaluate intervention-related feasibility outcomes. To provide preliminary comparative information regarding effectiveness, a matched non-exercise control group was included. Frequency matching will be used at the group level according to sex, 10-year age categories and Hoehn & Yahr stage categories (1-1.5, 2-2.5 and 3). Individual 1:1 matching will not be required. This approach was selected to reduce baseline imbalance while maintaining the feasibility of recruitment within a real-world community setting. The sample size was determined according to the primary feasibility objective, specifically the precision of the estimated adherence rate. Assuming an expected adherence rate of approximately 80%, 28 participants would provide an estimation precision of approximately ±15% with a 95% confidence interval. Considering potential attrition, the intervention group sample size was increased to 32 participants. A matched non-exercise control group of 32 participants will also be recruited, resulting in a total target sample size of 64 participants. Participants with Hoehn & Yahr stages 1-3 will be recruited from Asociación Parkinson Madrid and other Parkinson's disease associations in the Madrid region. The intervention group will participate in a 12-week multimodal exercise programme consisting of two weekly supervised face-to-face sessions and one weekly home-based session. The programme includes strength training, cardiovascular/balance exercise and cognitive-motor exercises. Exercise prescription and progression were individualised according to participant tolerance, functional capacity, motor performance, and safety considerations. Training intensity was monitored and adjusted using 10-repetition maximum principles, repetitions in reserve (RIR), and perceived exertion scales including OMNI-RES and Borg ratings. Exercise prescription and progression were individualised according to participant tolerance, functional capacity, motor performance, and safety considerations. All supervised sessions were delivered by physiotherapists experienced in neurological rehabilitation and exercise prescription for Parkinson's disease. Outcomes will be assessed at baseline, post-intervention and 6-month follow-up. Feasibility outcomes will be analysed descriptively using frequencies, percentages, means and confidence intervals where appropriate. Secondary clinical outcomes measured at baseline, post-intervention and 6-month follow-up will be analysed using linear mixed-effects models including group, time and group-by-time interaction effects. Estimated between-group differences, 95% confidence intervals and effect sizes will be reported. Given the feasibility nature of the study and the non-randomized sequential design, efficacy analyses will be interpreted as exploratory and hypothesis-generating rather than confirmatory.
Interventions
OTHERExercise 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
Sponsors
Universidad Rey Juan Carlos
Asociación Parkinson Madrid
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria The eligibility criteria will be identical for both the experimental and control groups. However, this study will employ a sequential recruitment design. Participants for the control group will be recruited following the experimental group and will be matched (1:1 ratio) based on sex, age (± 5 years), and disease severity according to the Hoehn \& Yahr (H\&Y) scale. Inclusion Criteria: * Subjects diagnosed with Idiopathic Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria. * Subjects staged between 1 and 3 on the Hoehn \& Yahr Scale. For matching purposes, stage 1 includes stage 1.5, and stage 2 includes stage 2.5.
Exclusion criteria
* Subjects diagnosed with a neurological disease other than PD. * Those diagnosed with a cardiovascular, respiratory, or metabolic disease or other conditions that represent a contraindication to physical exercise. * Those who have suffered an exacerbation or hospitalization in the last three months prior to starting the assessment protocol or during the therapeutic intervention process. * Those who have received a course of steroids, intravenously or orally, six months prior to the start of the study or during the therapeutic intervention process. * Those with cognitive impairment (defined as a score \< 21 on the Montreal Cognitive Assessment, MoCA) or language impairments that prevent adequate communication, comprehension, or following of exercise instructions. * Participation in a structured, individualized strength and/or aerobic exercise program within the three months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent rate | 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 | Baseline | It will be evaluated as the proportion of enrolled participants relative to the number of eligible participants screened |
| Adherence rate | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unified Parkinson Disease Rating Scale Part 3 (UPDRS-3) | At 12 weeks from Baseline | 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) |
| Change in Balance Berg Scale | At 12 weeks from Baseline | This scale measures static and dynamic balance through 14 tasks. Each task is scored from 0 (worst score) to 4 (best score) |
| Change in Non-Motor Symptoms Scale (NMSS) | At a 12 weeks from Baseline | 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. |
| Change in 10 Repetition Maximum (10-RM) | At 12 weeks from Baseline | 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. |
| Change in Isometric Handgrip Strength | At 12 weeks from Baseline | A dynamometer is used to measure the maximum handgrip strength with both hands for three times. The mean is obtained after the three attempts. |
| Change in Dynamic Fatigability | At 12 weeks from Baseline | A dynamometer is employed and the subject is asked to perform 15 consecutive maximum handgrip contractions. |
| Change in Five Times Sit to Stand Test | At 12 weeks from Baseline | 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. |
| Change in 6 Minute Walk Test | At 12 weeks from Baseline | This test assesses the distance a person is capable to walk as fast as possible for 6 minutes. |
| Change in Functional Movement Screen | At 12 weeks from Baseline | 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). |
| Change in King´s Parkinson´s Disease Pain Scale score | At 12 weeks from Baseline | 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. |
| Change in Brief Pain Inventory | At 12 weeks from Baseline | 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. |
| Change in Pressure Pain Threshold | At 12 weeks from Baseline | 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. |
| Change in Conditioned Pain Modulation | At 12 weeks from Baseline | 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. |
| Change in Exercise-Induced Hypoalgesia | At 12 weeks from Baseline | 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. |
| Change in Tampa Scale of Kinesiophobia | At 12 weeks from Baseline | Measures fear of movement-related pain. Its scores range from 11-44 points with higher scores indicating greater fear of pain, movement, and injury |
| Pain Catastrophizing Scale | At 12 weeks from Baseline | 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. |
| Change In Fatigue Severity Scale | At 12 weeks from Baseline | 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). |
| Change in Parkinson's Disease Sleep Scale 2 (PDSS-2) | At 12 weeks from Baseline | 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". |
| Change in State-Trait Anxiety Inventory | At 12 weeks from Baseline | 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. |
| Change in Beck Depression Inventory | At 12 weeks from Baseline | 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. |
| Change in Global Physical Activity Questionnaire (GPAQ) | At 12 weeks from Baseline | 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. |
Countries
Spain
Contacts
CONTACTMario González Iglesias, MSc PhD Student, Physiotherapy
CONTACTYeray González Zamorano, PhD, Physiotherapy
PRINCIPAL_INVESTIGATORMario González Iglesias, Physiotherapy
Universidad Rey Juan Carlos
Outcome results
None listed