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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2024-10-18
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-10-17
• Last updated: 2026-02-27

Locations

1 site across 1 country: Brazil