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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
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 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.
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
RECRUITINGChange 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.
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
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.
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
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.
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
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.
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
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.
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
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