Training Programs Effects on Strength and Balance in Older Adults

NCT05769361 | Completed

• 1 other identifier: UNST2223
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall

Outcome Measures

Primary Outcomes (6)

• Center of Pressure (CoP) Unit Path

  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;

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

• Center of Pressure (CoP) Area95

  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.

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

• Center of Pressure (CoP) First Peak

  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.

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

• Center of Pressure (CoP) Maximal Oscillation

  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.

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

• Center of Pressure (CoP) Post Perturbation Variability

  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.

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

• Lower limb isometric strength

  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.

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

Secondary Outcomes (2)

• Timed Up and Go (TUG) test

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

• 10-meter walking test

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

Study Arms (3)

Unstable (UNST)

EXPERIMENTAL

12-week training protocol with unstable devices, twice a week.

Behavioral: UNST

Stable (ST)

EXPERIMENTAL

12-week training protocol with stable devices, twice a week

Behavioral: ST

Control (CTRL)

NO INTERVENTION

No administration of training protocols.

Interventions

UNST BEHAVIORAL

Strength and balance training using different destabilizing devices

Unstable (UNST)

ST BEHAVIORAL

Strength and balance training over firm surfaces

Stable (ST)

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Nutrition and Exercise Lab, DSB, University of Padova

Padua, 35131, Italy

Location

Related Publications (1)

• Rizzato A, Bozzato M, Rotundo L, Zullo G, De Vito G, Paoli A, Marcolin G. Multimodal training protocols on unstable rather than stable surfaces better improve dynamic balance ability in older adults. Eur Rev Aging Phys Act. 2024 Jul 12;21(1):19. doi: 10.1186/s11556-024-00353-8.

  PMID: 38997647 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind study: only the researchers doing the study know which treatment or intervention the participant is receiving until the study is over.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: March 15, 2023
• Study Start: March 7, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)