- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06646523
Effects of Home-based High-speed Bodyweight Resistance Training in Individual With Parkinson's Disease
Effects of Remotely Supervised Home-based High-speed Bodyweight Resistance Training on Bradykinesia in Individuals With Parkinson's Disease: A Randomized Clinical Trial
Study Overview
Status
Conditions
Detailed Description
The sample size calculation was performed considering the primary outcome measures bradykinesia (assessed using items 3.8, 3.9, 3.10, and 3.14 of the motor examination of the MDS-UPDRS) based on data provided by previous similar randomized controlled trial. The effect size for bradykinesia was derived from a previous study. In that study, the groups showed a difference in means of -2.3 (treatment effect), using a standard deviation of 2.5, a significance level (α) of 5% and a power of 0.80, a sample size of 40 participants are required. Assuming a dropout rate of 15%, a total of 46 participants will be recruited (23 per group).
All statistical analyses will be performed by an independent examiner blinded to group allocation using the SPSS for Windows (SPSS, Chicago, IL, USA). Baseline characteristics will be summarized by treatment group using descriptive statistics. Means (standard deviation [SD]) or median (interquartile range [IQR]) will be used for continuous variables according to previous analysis of normality distribution (Shapiro-Wilk test). Frequency (percentage) will be used for categorical variables.
All analyses will follow the intention-to-treat principle, including all randomized participants in the groups to which they were originally allocated. The primary outcome will be bradykinesia of the lower limbs score with the primary endpoint defined as the post-intervention assessment at 12 weeks. Analytical approaches will be used to handle missing data, as recommended by Jakobsen et al. (2017). The specific procedure will depend on the proportion of missing data, as stated by Jakobsen et al. (2017). The statistical models will include a random intercept for participants and fixed effects for time (pre-intervention, post-intervention, and follow-up), group (intervention and control), and group-by-time interaction. The primary analysis will focus on the group-by-time interaction effect. The level of significance will be set at 5%. Effect estimates will be reported considering the confidence intervals (95% CI) for the between-group mean differences at each time point (week 12 minus week 0 and week 16 minus week 0). Secondary outcomes will be considered exploratory. Where applicable, adjustment for multiple comparisons will be performed using Bonferroni method.
Adverse events will be summarized descriptively by treatment group, including the number and proportion of participants experiencing at least one event, as well as the frequency and severity of events.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 31270-901
- Federal University of Minas Gerais
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- ≥50 years old;
- Parkinson's disease diagnosed by a neurologista;
- classified between stages 1-3 of the modified Hoehn & Yahr Scale;
- present bradykinesia identified by items 3.8 (Leg Agility) and/or 3.14 (Global Spontaneity of Movement - Body Bradykinesia) of the motor examination of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with a minimum score of 1 out of 4 points in at least one of the items;
- taking antiparkinsonian medication, and who have been medically stable
- are classified as inactive or insufficiently active; have ability to walk independently without assistive devices; and have written medical permission to allow them to participate in the study. The Centers for Disease Control and Prevention classification will be used to determine if an individual is inactive or insufficiently active. Participants will be asked about the exercises they performed most often over the last 4 weeks, including their frequency and duration. Individuals who report that they have performed physical exercise over the last month at least five times per week for more than 30 min at a moderate intensity or at least three times per week for at least 20 min at a vigorous intensity will be classified as having moderate or vigorous exercise levels, respectively. Individuals who report not having practiced any exercise over the last month will be classified as inactive. Those who report doing physical exercise over the last month that is not classified as vigorous or moderate intensity will be classified as insufficiently active.
Exclusion Criteria:
- cognitive impairments as determined by cutoff scores (in points) of the Mini-Mental Status Examination according to education level reference;
- any other neurological, musculoskeletal, cardiovascular, or respiratory disorders that could affect their ability to perform the tests;
- used deep brain stimulation (DBS);
- no access to the internet;
- who do not have a caregiver or family member who can assist during the intervention sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-speed bodyweight resistance training
The participants of the experimental group (high-speed bodyweight resistance training) will receive a home-based intervention that will include 5 minutes of warm-up (free active movements of trunk and lower limbs), followed by 50 min of exercises more targeted to the lower limb muscles, and by 5 minutes of cool-down (lower limb muscle stretching and relaxation breathing exercise). The experimental intervention will be performed at maximum speed. During the initial home visit, the speed at which the participant can perform one set of each exercise at maximum speed will be timed. Speed-based progression will be determined every four weeks by increasing the number of repetitions in each set of exercises performed during subsequent home visits. |
The participants of the experimental group (high-speed bodyweight resistance training) will receive a home-based intervention that will include 5 minutes of warm-up (free active movements of trunk and lower limbs), followed by 50 min of exercises more targeted to the lower limb muscles, and by 5 minutes of cool-down (lower limb muscle stretching and relaxation breathing exercise). The experimental intervention will be performed at maximum speed. During the initial home visit, the speed at which the participant can perform one set of each exercise at maximum speed will be timed. Speed-based progression will be determined every four weeks by increasing the number of repetitions in each set of exercises performed during subsequent home visits. |
|
Sham Comparator: Control group (Bodyweight intervention, usual speed)
The participants of the control group (Bodyweight intervention, usual speed) will also receive a home-based intervention that will include 5 minutes of warm-up (free active movements of trunk and lower limbs), followed by 50 min of exercises more targeted to the lower limb muscles, and by 5 minutes of cool-down (lower limb muscle stretching and relaxation breathing exercise). The control intervention will be performed at the usual speed. The same procedures that will be carried out to determine the maximum speed in the experimental group will be used to determine the usual speed in the control group. There will be no progression in the speed of performing the exercises. However, participants in the control group will also receive a home visit from the main researcher every four weeks to avoid bias related to the amount of attention given to participants in the experimental group. |
The participants of the control group (Bodyweight intervention, usual speed) will also receive a home-based intervention that will include 5 minutes of warm-up (free active movements of trunk and lower limbs), followed by 50 min of exercises more targeted to the lower limb muscles, and by 5 minutes of cool-down (lower limb muscle stretching and relaxation breathing exercise). The control intervention will be performed at the usual speed. The same procedures that will be carried out to determine the maximum speed in the experimental group will be used to determine the usual speed in the control group. There will be no progression in the speed of performing the exercises. However, participants in the control group will also receive a home visit from the main researcher every four weeks to avoid bias related to the amount of attention given to participants in the experimental group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Bradykinesia - Unified Parkinson's Disease Rating Scale
Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
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Bradykinesia of the lower limbs will be measured using item 3.8 (Leg Agility), assessed bilaterally (right and left), and item 3.14 (Global Spontaneity of Movement - Body Bradykinesia) of the motor examination of the MDS-UPDRS.
Each score ranges from 0 to 4, with 0 indicating normal function and 4 indicating severe impairment.
The primary bradykinesia outcome will be calculated as the sum of the bilateral scores for item 3.8 and the score for item 3.14, resulting in a composite score ranging from 0 to 12. Higher scores indicate more severe bradykinesia.
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At baseline, 12 weeks post-intervention, and at 4-week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Mobility - 10-m walk test
Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
|
Mobility will be measured using the 10-m walk test.
Participants will be instructed to walk at both comfortable and maximal speeds in a 14-m hallway and the time taken to cover the central 10-m will be timed.
A digital stopwatch will be used to measure three comfortable and maximal speeds measurements.
The average of the three measurements will be used for analysis.
|
At baseline, 12 weeks post-intervention, and at 4-week follow-up
|
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Change from baseline in Muscle power - Five Time Sit to Stand
Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
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Muscle power will be assessed using Five Time Sit to Stand.
Participants will be instructed to perform five time sit to stand repetitions as rapidly as possible using a chair without armrests and with a standardized height.
The time needed to complete the task will be recorded with a stopwatch.
Only one repetition will be performed after one or two familiarization.
Mean muscle power will be obtained by the product of mean velocity and mean force.
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At baseline, 12 weeks post-intervention, and at 4-week follow-up
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Change from baseline in Dynamic balance - Mini-Balance Evaluation System's Test
Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
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Dynamic balance will be assessed using Mini-Balance Evaluation System's Test.
This test assesses changes in balance representing four domains of dynamic balance: anticipatory postural adjustments, postural responses, sensory orientation, and dynamic gait.
The Mini-Balance Evaluation System's Test is composed of 14 items, and for each item, the scores range from 0 to 2. A higher score indicates better performance.
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At baseline, 12 weeks post-intervention, and at 4-week follow-up
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Change from baseline in Quality of life - Parkinson's Disease Questionnaire-39
Time Frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
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Quality of life will be measured using Parkinson's Disease Questionnaire-39.
The Parkinson's Disease Questionnaire-39 is composed of 39 items divided into eight dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.
The score for each item ranges from 0 to 4, and for each dimension varies from 0 to 100.
A higher score indicates worse the individual's perception of quality of life.
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At baseline, 12 weeks post-intervention, and at 4-week follow-up
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christina CM Faria, Ph.D., Federal University of Minas Gerais
Publications and helpful links
General Publications
- Morris ME. Movement disorders in people with Parkinson disease: a model for physical therapy. Phys Ther. 2000 Jun;80(6):578-97.
- Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.
- Bertolucci PH, Brucki SM, Campacci SR, Juliano Y. [The Mini-Mental State Examination in a general population: impact of educational status]. Arq Neuropsiquiatr. 1994 Mar;52(1):1-7. Portuguese.
- Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.
- Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.
- Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.
- Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537.
- Lim LI, van Wegen EE, de Goede CJ, Jones D, Rochester L, Hetherington V, Nieuwboer A, Willems AM, Kwakkel G. Measuring gait and gait-related activities in Parkinson's patients own home environment: a reliability, responsiveness and feasibility study. Parkinsonism Relat Disord. 2005 Jan;11(1):19-24. doi: 10.1016/j.parkreldis.2004.06.003.
- Alcazar J, Losa-Reyna J, Rodriguez-Lopez C, Alfaro-Acha A, Rodriguez-Manas L, Ara I, Garcia-Garcia FJ, Alegre LM. The sit-to-stand muscle power test: An easy, inexpensive and portable procedure to assess muscle power in older people. Exp Gerontol. 2018 Oct 2;112:38-43. doi: 10.1016/j.exger.2018.08.006. Epub 2018 Sep 1.
- Centers for Disease Control and Prevention (CDC). Physical activity trends--United States, 1990-1998. MMWR Morb Mortal Wkly Rep. 2001 Mar 9;50(9):166-9.
- Vasconcellos LS, Silva RS, Pacheco TB, Nagem DA, Sousa CO, Ribeiro TS. Telerehabilitation-based trunk exercise training for motor symptoms of individuals with Parkinson's disease: A randomized controlled clinical trial. J Telemed Telecare. 2023 Oct;29(9):698-706. doi: 10.1177/1357633X211021740. Epub 2021 Jun 18.
- Lai B, Rimmer J, Barstow B, Jovanov E, Bickel CS. Teleexercise for Persons With Spinal Cord Injury: A Mixed-Methods Feasibility Case Series. JMIR Rehabil Assist Technol. 2016 Jul 14;3(2):e8. doi: 10.2196/rehab.5524.
- Jaque C, Veliz P, Ramirez-Campillo R, Moran J, Gentil P, Cancino J. High-Speed Bodyweight Resistance Training Improves Functional Performance Through Maximal Velocity in Older Females. J Aging Phys Act. 2021 Aug 1;29(4):659-669. doi: 10.1123/japa.2020-0129. Epub 2020 Dec 25.
- Jaque-Gallardo C, Veliz-Campillay P, Cancino-Lopez J. [Effect of a high-speed bodyweight resistance training on timed up and go and one leg stance in older women]. Rev Med Chil. 2019 Sep;147(9):1136-1143. doi: 10.4067/s0034-98872019000901136. Spanish.
- Ni M, Signorile JF, Mooney K, Balachandran A, Potiaumpai M, Luca C, Moore JG, Kuenze CM, Eltoukhy M, Perry AC. Comparative Effect of Power Training and High-Speed Yoga on Motor Function in Older Patients With Parkinson Disease. Arch Phys Med Rehabil. 2016 Mar;97(3):345-354.e15. doi: 10.1016/j.apmr.2015.10.095. Epub 2015 Nov 4.
- Ni M, Signorile JF, Balachandran A, Potiaumpai M. Power training induced change in bradykinesia and muscle power in Parkinson's disease. Parkinsonism Relat Disord. 2016 Feb;23:37-44. doi: 10.1016/j.parkreldis.2015.11.028. Epub 2015 Nov 27.
- Ridgel AL, Ault DL. High-Cadence Cycling Promotes Sustained Improvement in Bradykinesia, Rigidity, and Mobility in Individuals with Mild-Moderate Parkinson's Disease. Parkinsons Dis. 2019 Mar 3;2019:4076862. doi: 10.1155/2019/4076862. eCollection 2019.
- Uygur M, Bellumori M, LeNoir K, Poole K, Pretzer-Aboff I, Knight CA. Immediate effects of high-speed cycling intervals on bradykinesia in Parkinson's disease. Physiother Theory Pract. 2015 Feb;31(2):77-82. doi: 10.3109/09593985.2014.972530. Epub 2014 Oct 27.
- Bologna M, Paparella G, Fasano A, Hallett M, Berardelli A. Evolving concepts on bradykinesia. Brain. 2020 Mar 1;143(3):727-750. doi: 10.1093/brain/awz344.
- Benfica PDAY, Scianni AA, Soares CLA, Ribeiro IL, Casado PV, Faria CDCM. Effects of Remotely Supervised Home-Based High-Speed Bodyweight Resistance Training on Bradykinesia in Individuals With Parkinson Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 May 4;15:e84689. doi: 10.2196/84689.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Dyskinesias
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Parkinson Disease
- Hypokinesia
- Motor Activity
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- CAAE: 68350023.7.0000.5149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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