Parkinson DiseaseNCT06646523
Effects of Home-based High-speed Bodyweight Resistance Training in Individual With Parkinson's Disease
A study testing High-speed bodyweight resistance training in people with Parkinson Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Exercises that involve increasing the speed of movements are beneficial for individuals with Parkinson's disease (PD) and have the potential to reduce bradykinesia and improve mobility. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- High-speed bodyweight resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Oct 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Effects of Remotely Supervised Home-based High-speed Bodyweight Resistance Training on Bradykinesia in Individuals With Parkinson's Disease: A Randomized Clinical Trial
Exercises that involve increasing the speed of movements are beneficial for individuals with Parkinson's disease (PD) and have the potential to reduce bradykinesia and improve mobility. High-speed bodyweight resistance training is a treatment that involves increasing speed considered accessible and viable as it can be performed at any time and place, including at home. This treatment has already shown benefits in the elderly individuals, however no studies were found in individuals with PD. Therefore, the primary aim of this study will be to investigate the effects of home-based and remotely supervised high-speed bodyweight resistance training in reducing bradykinesia in individuals with PD. The secondary aim will be to investigate the effects of home-based and remotely supervised high-speed bodyweight resistance training in improving mobility, muscle power, dynamic balance, and quality of life in this population. A randomized controlled trial will be carried out with concealed allocation, blinded assessments, and intention-to-treat analysis. Altogether, 46 individuals with PD (age ≥ 50 years old, who are bradykinetics and sedentary or insufficiently active will be included. Participants will be randomly assigned to either an experimental group (high-speed bodyweight resistance training) or a control group (bodyweight intervention, usual speed). Both groups will perform a home-based and remotely supervised intervention, consisting of 60-min individual sessions, three times per week over 12 weeks, with a trained physiotherapist. Primary outcomes is bradykinesia of the lower limbs. Secondary outcomes are mobility, muscle power, dynamic balance, and quality of life. The findings of this trial have the potential to provide important insights regarding the effects of high-speed bodyweight resistance training in reducing bradykinesia and improving mobility in individuals with PD. High-speed bodyweight resistance training does not use any type of external resistance and can be performed anywhere and at any time. In addition, it can be performed at home through telemonitoring, reducing time and costs of transport, making it quite feasible and accessible for individuals from different social and economic backgrounds which increases the feasibility of reproducing their findings in clinical practice.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- High-speed bodyweight resistance training, Control group (Bodyweight intervention, usual speed)
- Keywords
- Exercise, Bradykinesia, Mobility, Rehabilitation, Parkinson disease
- Medical subject headings
- Parkinson Disease, Motor Activity, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-speed bodyweight resistance trainingOther
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.
Control group (Bodyweight intervention, usual speed)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| High-speed bodyweight resistance training | Experimental | 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. Receives: Other: High-speed bodyweight resistance training |
| Control group (Bodyweight intervention, usual speed) | Sham comparator | 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. Receives: Other: Control group (Bodyweight intervention, usual speed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Bradykinesia - Unified Parkinson's Disease Rating Scale
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.
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Secondary outcomes (4)
Change from baseline in Mobility - 10-m walk test
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.
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Muscle power - Five Time Sit to Stand
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.
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Dynamic balance - Mini-Balance Evaluation System's Test
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.
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Quality of life - Parkinson's Disease Questionnaire-39
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.
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start18 Oct 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
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 DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais
- Investigators
- Christina CM Faria, Ph.D., Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646523
- Sponsor's protocol ID
- CAAE: 68350023.7.0000.5149
- Status last verified
- May 2026
- First submitted
- 11 Oct 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9351479Franchignoni 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.
PubMed 20461334Alcazar 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.
PubMed 30179662Lim 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.
PubMed 15619458Bertolucci 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.
PubMed 8002795Centers 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.
PubMed 11393487Goetz 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.
PubMed 19025984Hoehn 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.
PubMed 6067254Vasconcellos 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.
PubMed 34142896Lai 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.
PubMed 28582252Jaque 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.
PubMed 33361494Jaque-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.
PubMed 33625447Ni 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.
PubMed 26546987Ni 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.
PubMed 26698015Ridgel 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.
PubMed 30944720
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remotely Supervised Home-based High-speed Bodyweight Resistance Training on Bradykinesia in Individuals With Parkinson's Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06646523
- Acronym / sponsor ID
- CAAE: 68350023.7.0000.5149
- Conditions
- Parkinson Disease
- Keywords
- Exercise, Bradykinesia, Mobility, Rehabilitation, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 17 Oct 2024 (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.
Exercises that involve increasing the speed of movements are beneficial for individuals with Parkinson's disease (PD) and have the potential to reduce bradykinesia and improve mobility. High-speed bodyweight resistance training is a treatment that involves increasing speed considered accessible and viable as it can be performed at any time and place, including at home. This treatment has already shown benefits in the elderly individuals, however no studies were found in individuals with PD. Therefore, the primary aim of this study will be to investigate the effects of home-based and remotely supervised high-speed bodyweight resistance training in reducing bradykinesia in individuals with PD. The secondary aim will be to investigate the effects of home-based and remotely supervised high-speed bodyweight resistance training in improving mobility, muscle power, dynamic balance, and quality of life in this population. A randomized controlled trial will be carried out with concealed allocation, blinded assessments, and intention-to-treat analysis. Altogether, 46 individuals with PD (age ≥ 50 years old, who are bradykinetics and sedentary or insufficiently active will be included. Participants will be randomly assigned to either an experimental group (high-speed bodyweight resistance training) or a control group (bodyweight intervention, usual speed). Both groups will perform a home-based and remotely supervised intervention, consisting of 60-min individual sessions, three times per week over 12 weeks, with a trained physiotherapist. Primary outcomes is bradykinesia of the lower limbs. Secondary outcomes are mobility, muscle power, dynamic balance, and quality of life. The findings of this trial have the potential to provide important insights regarding the effects of high-speed bodyweight resistance training in reducing bradykinesia and improving mobility in individuals with PD. High-speed bodyweight resistance training does not use any type of external resistance and can be performed anywhere and at any time. In addition, it can be performed at home through telemonitoring, reducing time and costs of transport, making it quite feasible and accessible for individuals from different social and economic backgrounds which increases the feasibility of reproducing their findings in clinical practice.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-speed bodyweight resistance training | Experimental | Other: High-speed bodyweight resistance trainingThe 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. |
| Control group (Bodyweight intervention, usual speed) | Sham comparator | Other: 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| High-speed bodyweight resistance trainingThe 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. | Other | High-speed bodyweight resistance training |
| 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. | Other | Control group (Bodyweight intervention, usual speed) |
Primary outcome
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
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.
4 secondary outcomes
Change from baseline in Mobility - 10-m walk test
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 9351479Jenkinson 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.
- Background: PubMed 20461334Franchignoni 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.
- Background: PubMed 30179662Alcazar 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.
- Background: PubMed 15619458Lim 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.
- Background: PubMed 8002795Bertolucci 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.
- Background: PubMed 11393487Centers 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.
- Background: PubMed 19025984Goetz 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.
- Background: PubMed 6067254Hoehn 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.
- Background: PubMed 34142896Vasconcellos 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.
- Background: PubMed 28582252Lai 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.
- Background: PubMed 33361494Jaque 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.
- Background: PubMed 33625447Jaque-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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christina CM Faria, Ph.D. principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-speed bodyweight resistance training in people with Parkinson Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 26 May 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06646523, 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 26 May 2026.