Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646523
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Effects of Home-based High-speed Bodyweight Resistance Training in Individual with Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Remotely Supervised Home-based High-speed Bodyweight Resistance Training on Bradykinesia and Mobility in Individuals with Parkinsons Disease a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Exercises that involve increasing the speed of movements are beneficial for individuals with Parkinsons 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 and improving mobility 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 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 38 39 310 and 314 of the motor examination of the MDS-UPDRS and mobility assessed using the 10-m walk test based on data provided by previous similar randomized controlled trials The effect size for bradykinesia was derived from a previous study In that study the groups showed a difference in means of -23 treatment effect using a standard deviation of 25 a significance level α of 5 and a power of 080 a sample size of 40 participants are required The effect size for mobility was derived from another previous study In that study the groups showed a difference in means of 03 using a standard deviation of 02 a significance level α of 5 and a power of 080 a sample size of 18 participants are required Therefore a sample size of 46 individuals 23 in each group was defined assuming an expected dropout rate of 15 of drop off
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None