Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-02-21 @ 1:26 PM
Study NCT ID:
NCT05769361
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2022-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training Programs Effects on Strength and Balance in Older Adults
Sponsor:
University of Padova
Organization:
Study Overview
Official Title:
Effect of a 12-week Training Program With Unstable Devices on Strength and Dynamic Balance in Older Adults
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ageing involves several physiological changes such as loss of muscle mass, muscle strength, and alteration of balance control mechanisms. Consequently, there is an increased fall risk that can lead the older adult to a reduced self-sufficiency in daily living activities. Investigating the role of different physical activities to counteract the age-related declines deserves attention. The present study aimed to evaluate the effects of two trainings performed with and without unstable devices, on dynamic balance control and lower limb strength compared to a control group that received no intervention.
Detailed Description:
The a-priori power analysis calculation reported a total sample size of 51 participants. We decided to increase the sample size of approximatively 20% hypothesizing an increment of drop-outs due to the not completely solved COVID-19 pandemic at the time of the study.
In this single-blinded randomized controlled study, both intervention groups received 24 training sessions of 45 minutes each, twice a week for 12 weeks.The two intervention groups and the control group were tested at the baseline (T0), after six weeks (T1), and after twelve weeks (T2).
Subjects of the intervention groups had to complete at least 21 out of 24 training sessions. Moreover, all subjects had to complete all the assessments. Otherwise, they were completely excluded from the data analysis.
In this single-blinded randomized controlled study, both intervention groups received 24 training sessions of 45 minutes each, twice a week for 12 weeks.The two intervention groups and the control group were tested at the baseline (T0), after six weeks (T1), and after twelve weeks (T2).
Subjects of the intervention groups had to complete at least 21 out of 24 training sessions. Moreover, all subjects had to complete all the assessments. Otherwise, they were completely excluded from the data analysis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: