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Clinical Trials/NCT05769361
NCT05769361
Completed
N/A

Effect of a 12-week Training Program With Unstable Devices on Strength and Dynamic Balance in Older Adults

University of Padova1 site in 1 country62 target enrollmentMarch 7, 2022
ConditionsFall

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fall
Sponsor
University of Padova
Enrollment
62
Locations
1
Primary Endpoint
Center of Pressure (CoP) Area95
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2022
End Date
April 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Padova
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • self-sufficiency in daily living activities;
  • aged between 65 and 85 years.

Exclusion Criteria

  • non-corrected sight disorders
  • neurological disorders
  • regular assumption of drugs that can interfere with normal cognitive functioning
  • pathologies that contraindicate physical activity practice

Outcomes

Primary Outcomes

Center of Pressure (CoP) Area95

Time Frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - The area of the 95th percentile confidence ellipse of the CoP measured in cm2 (Area95) over a 2.5-second time window from the beginning of the perturbation.

Center of Pressure (CoP) Post Perturbation Variability

Time Frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - The standard deviation (SD) of the CoP anterior-posterior displacement over a 2.5-second time window from the beginning of the perturbation as the post perturbation variability (PPV), measured in centimeters.

Lower limb isometric strength

Time Frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

Isometric quadriceps maximal strength (Newton) measured with an instrumented chair. Specifically, a load cell is placed perpendicular to the subject's shank and collects the force in Newton expressed by the subject while sitting on the chair. The knee angle during the maximal effort is fixed at 90 degrees.

Center of Pressure (CoP) Unit Path

Time Frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - The mean velocity of the CoP measured in cm∙s-1 (Unit Path) over a 2.5-second time window from the beginning of the perturbation;

Center of Pressure (CoP) First Peak

Time Frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - First peak (FP) as the difference in centimeters between the peak reached by the CoP displacement after the external perturbation and the mean value of the anterior-posterior CoP displacement before the perturbation.

Center of Pressure (CoP) Maximal Oscillation

Time Frame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)

From the center of pressure (CoP) trajectory the following parameter is calculated in the dynamic test: - Maximal oscillation of the CoP anterior-posterior displacement as the sum in centimeters of the absolute values of FP and the subsequent peak.

Secondary Outcomes

  • 10-meter walking test(At baseline (t0), after six weeks (t1) and after 12 weeks (t2))
  • Timed Up and Go (TUG) test(At baseline (t0), after six weeks (t1) and after 12 weeks (t2))

Study Sites (1)

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