Clinical trial NCT06646523: Effects of Home-based High-speed Bodyweight Resistance Training in Individual with Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Exercise
Bradykinesia
Mobility
Rehabilitation
Parkinson disease
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2024-10-17
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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 are bradykinesia of the lower limbs and mobility. Secondary outcomes are muscle power, dynamic balance, and quality of life. Between-group differences will be measured by two-way repeated measures ANOVA, considering the baseline, post-training, and 4-week follow-up. 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 the group allocation. All data analyses will be performed using SPSS for Windows (SPSS, Chicago, IL, USA). Descriptive statistics will be calculated for all outcomes. The effects of the interventions will be analyzed from the collected data using intention-to-treat. For dropouts, data from the last available assessment will be used for missed sessions. Two-way ANOVA with repeated measures will be used to evaluate the differences between groups, considering the time factor (pre-intervention, post-intervention, and follow-up), followed by post hoc test selected based on final sample size and in the assumption of equal of variance. If necessary, a similar nonparametric test will be used. The level of significance will be set at 5%.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Bradykinesia - Unified Parkinson's Disease Rating Scale
timeFrame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Secondary outcomes:
measure: Change from baseline in Mobility - 10-m walk test
timeFrame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
measure: Change from baseline in Muscle power - Five Time Sit to Stand
timeFrame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
measure: Change from baseline in Dynamic balance - Mini-Balance Evaluation System's Test
timeFrame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
measure: Change from baseline in Quality of life - Parkinson's Disease Questionnaire-39
timeFrame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Christina CM Faria, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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