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

Browse trials for

• Parkinson Disease 4,573

Keywords

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

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 64 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Lead sponsor

Universidad Rey Juan Carlos is the lead sponsor of 114 studies on the registry; 24 are open to participants now.

Study arms

• Experimental
  Exercise group

  Two weekly in-person sessions of multimodal exercise that involve strength training, aerobic interval training / balance and coordination training and a cognitive-motor exercise, each session lasting 55-60 minutes. Additionally, one weekly home session lasting 25-30 minutes that include strength and aerobic training.

  Other: Exercise Group

• No intervention
  Control Group

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

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

Primary outcomes

1. Consent 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

2. Recruitment rate

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

   Time frame: Baseline

3. 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)

4. 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)

5. 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

6. 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)

7. 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)

8. 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

9. 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)

10. 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)

11. 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)

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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 39 weeks from Baseline

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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

Publications

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• Aschbrenner KA, Kruse G, Gallo JJ, Plano Clark VL. Applying mixed methods to pilot feasibility studies to inform intervention trials. Pilot Feasibility Stud. 2022 Sep 26;8(1):217. doi: 10.1186/s40814-022-01178-x. PubMed 36163045 ↗
• Danoudis M, Iansek R. A long-term community gym program for people with Parkinson's disease: a feasibility study of the Monash Health "Health and Fitness" model. Disabil Rehabil. 2022 Nov;44(23):7330-7338. doi: 10.1080/09638288.2021.1977396. Epub 2021 Sep 21. PubMed 34546146 ↗
• Morris ME, Taylor NF, Watts JJ, Evans A, Horne M, Kempster P, Danoudis M, McGinley J, Martin C, Menz HB. A home program of strength training, movement strategy training and education did not prevent falls in people with Parkinson's disease: a randomised trial. J Physiother. 2017 Apr;63(2):94-100. doi: 10.1016/j.jphys.2017.02.015. Epub 2017 Mar 14. PubMed 28342682 ↗
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• Avenali M, Picascia M, Tassorelli C, Sinforiani E, Bernini S. Evaluation of the efficacy of physical therapy on cognitive decline at 6-month follow-up in Parkinson disease patients with mild cognitive impairment: a randomized controlled trial. Aging Clin Exp Res. 2021 Dec;33(12):3275-3284. doi: 10.1007/s40520-021-01865-4. Epub 2021 May 12. PubMed 33978924 ↗
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• Mylius V, Perez Lloret S, Cury RG, Teixeira MJ, Barbosa VR, Barbosa ER, Moreira LI, Listik C, Fernandes AM, de Lacerda Veiga D, Barbour J, Hollenstein N, Oechsner M, Walch J, Brugger F, Hagele-Link S, Beer S, Rizos A, Chaudhuri KR, Bouhassira D, Lefaucheur JP, Timmermann L, Gonzenbach R, Kagi G, Moller JC, Ciampi de Andrade D. The Parkinson disease pain classification system: results from an international mechanism-based classification approach. Pain. 2021 Apr 1;162(4):1201-1210. doi: 10.1097/j.pain.0000000000002107. PubMed 33044395 ↗
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• Martinez-Martin P, Rodriguez-Blazquez C, Kurtis MM, Chaudhuri KR; NMSS Validation Group. The impact of non-motor symptoms on health-related quality of life of patients with Parkinson's disease. Mov Disord. 2011 Feb 15;26(3):399-406. doi: 10.1002/mds.23462. Epub 2011 Jan 24. PubMed 21264941 ↗
• Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424. PubMed 26474316 ↗
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Individual participant data

Plan to share: Yes — Individual anonymized participant data will be available to other researchers under request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Six months at the end of the study.

Access criteria: Individual anonymized participant data will be available to other researchers under request.