Training Programs Effects on Strength and Balance in Older Adults

NCT ID: NCT05769361

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2023-04-28

Brief Summary

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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

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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.

Conditions

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Fall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Single-blind study: only the researchers doing the study know which treatment or intervention the participant is receiving until the study is over.

Study Groups

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Unstable (UNST)

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

Group Type EXPERIMENTAL

UNST

Intervention Type BEHAVIORAL

Strength and balance training using different destabilizing devices

Stable (ST)

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

Group Type EXPERIMENTAL

ST

Intervention Type BEHAVIORAL

Strength and balance training over firm surfaces

Control (CTRL)

No administration of training protocols.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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UNST

Strength and balance training using different destabilizing devices

Intervention Type BEHAVIORAL

ST

Strength and balance training over firm surfaces

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nutrition and Exercise Lab, DSB, University of Padova

Padua, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 38997647 (View on PubMed)

Other Identifiers

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UNST2223

Identifier Type: -

Identifier Source: org_study_id

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