Effects of Remotely Supervised Home-based High-speed Bodyweight Resistance Training on Bradykinesia in Individuals With Parkinson's Disease: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change from baseline in Bradykinesia - Unified Parkinson's Disease Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: High-speed bodyweight resistance training (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.
干预措施: Control group (Bodyweight intervention, usual speed) (Other)
结局指标
主要结局
Change from baseline in Bradykinesia - Unified Parkinson's Disease Rating Scale
时间窗: 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.
次要结局
- Change from baseline in Mobility - 10-m walk test(At baseline, 12 weeks post-intervention, and at 4-week follow-up)
- Change from baseline in Muscle power - Five Time Sit to Stand(At baseline, 12 weeks post-intervention, and at 4-week follow-up)
- Change from baseline in Dynamic balance - Mini-Balance Evaluation System's Test(At baseline, 12 weeks post-intervention, and at 4-week follow-up)
- Change from baseline in Quality of life - Parkinson's Disease Questionnaire-39(At baseline, 12 weeks post-intervention, and at 4-week follow-up)
研究者
Christina Danielli Coelho de Morais Faria
Associate professor
Federal University of Minas Gerais