Clinical trial NCT05769361: Training Programs Effects on Strength and Balance in Older Adults
Official title: Effect of a 12-week Training Program With Unstable Devices on Strength and Dynamic Balance in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Center of Pressure (CoP) Unit Path
timeFrame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
measure: Center of Pressure (CoP) Area95
timeFrame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
measure: Center of Pressure (CoP) First Peak
timeFrame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
measure: Center of Pressure (CoP) Maximal Oscillation
timeFrame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
measure: Center of Pressure (CoP) Post Perturbation Variability
timeFrame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
measure: Lower limb isometric strength
timeFrame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Secondary outcomes:
measure: Timed Up and Go (TUG) test
timeFrame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
measure: 10-meter walking test
timeFrame: At baseline (t0), after six weeks (t1) and after 12 weeks (t2)
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
References: