NCT07315321

Brief Summary

The increase in life expectancy, together with the high levels of physical inactivity in the population over 65 years of age, has generated a significant reduction in the quality of life of elderly people, characterized by the increase in functional dependence and risk of falling. In this sense, falls in this population are a serious public health problem, as they can cause fractures that not only exacerbate functional deterioration but can also lead to death. The current literature shows that low muscle strength and poor trunk stability, caused by aging, are associated with low balance levels and consequently with an increased risk of suffering a fall. Thus, there are many studies that have tried to develop trunk muscle conditioning programs as a preventive tool to improve balance, gait and functional mobility in older people. However, these exercise programs have not always shown as positive results as would be expected. One of the main reasons that could explain the heterogeneity of these results is the lack of valid and reliable protocols to objectively measure the intensity of trunk stabilization exercises. This makes trunk training program control and individualization difficult and hinders the proper dose-response characterization of these programs in older people. Therefore, this project aims to develop new protocols based on low cost and easy to use tools to objectively assess trunk stabilization exercise intensity/difficulty in any sports, geriatric or research facility. This would allow: to perform individualized trunk exercise programs to develop balance, reduce the risk of suffering a fall and improve the quality of life in older people; to increase the replicability of these training programs; and to facilitate, in the future, the establishing of dose/response relationships.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 18, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

intensitysmartphonebalanceolder adultsfunctional mobilitycore stabilitypostural control

Outcome Measures

Primary Outcomes (4)

  • Mean radial error of center of pressure in sitting and tandem condition

    Postural control in sitting condition over an unstable seat evaluated through the mean radial error of center of pressure displacement

    Baseline - 6 weeks

  • Pelvis mean acceleration

    Pelvis mean acceleration in different isometric stabilization exercises measured with a smartphone accelerometer

    Time Frame: Baseline - every 2 weeks up to 6 weeks

  • Functional mobility

    Time in Timed Up and Go Test

    Baseline - 6 weeks

  • Balance and gait under different conditions

    A smartphone app was used to analyze performance on both outcomes.

    Baseline-6 weeks

Study Arms (3)

Experimental: Low Intensity training group

EXPERIMENTAL

Low Intensity training group will complete a 6 week core stability training program with low intensity/oscillation exercises

Other: Core stability training

Experimental: High Intensity training group

EXPERIMENTAL

High Intensity training group will complete a 6 week core stability training program with high intensity/oscillation exercises

Other: Core stability training

No Intervention: Control group

NO INTERVENTION

Control group will have 6 weeks with no intervention before post-test

Interventions

This intervention includes an individualized core stability training in older adults

Also known as: TI2018-098893-BI00
Experimental: High Intensity training groupExperimental: Low Intensity training group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • People between 65-80 years of age
  • Independent walking
  • Habitual residence in the province of Alicante
  • People without osteoporosis, sarcopenia and/or fragility
  • Physical active people.

You may not qualify if:

  • Having a history of cardiorespiratory, musculoskeletal or any other type of alterations that contraindicate the practice of physical exercise
  • The existence of any type of spinal pathology or low back pain during the study or in the 12 months prior to the study
  • Having undergone abdominal or lumbar surgery
  • Presenting any osteo-articular and/or muscle-tendon pathology that could be aggravated by the different exploratory tests proposed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomechanics laboratory of Universidad Miguel Hernandez de Elche

Elche, Alicante, 03202, Spain

Location

Related Publications (2)

  • Heredia-Elvar JR, Juan-Recio C, Prat-Luri A, Barbado D, Vera-Garcia FJ. Observational Screening Guidelines and Smartphone Accelerometer Thresholds to Establish the Intensity of Some of the Most Popular Core Stability Exercises. Front Physiol. 2021 Oct 22;12:751569. doi: 10.3389/fphys.2021.751569. eCollection 2021.

    PMID: 34744790BACKGROUND
  • Barbado D, Irles-Vidal B, Prat-Luri A, Garcia-Vaquero MP, Vera-Garcia FJ. Training intensity quantification of core stability exercises based on a smartphone accelerometer. PLoS One. 2018 Dec 5;13(12):e0208262. doi: 10.1371/journal.pone.0208262. eCollection 2018.

    PMID: 30517171BACKGROUND

Study Officials

  • Francisco J Vera Garcia, Professor

    Universidad Miguel Hernández de Elche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 2, 2026

Study Start

January 7, 2022

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All Individual Participant Data (IPD) that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will be available six months after publication
Access Criteria
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement

Locations