NCT07555249

Brief Summary

The aim of this study was to compare the effects of two different training protocols on muscle strength, flexibility, aerobic endurance, balance and walking ability in older adults in order to reduce their fall risk. The participants (n=110) aged 65-85 years, self-sufficient and physically active, were randomly assigned to a resistance training (RT) group and a combined balance and strength (BS) group. Both groups attended supervised sessions of 3 hours twice a week for 6 weeks. To measure the functional fitness, before and after the training program the Senior Fitness Test Battery was used, while physical activity level and fear of falling were assessed with self-reported questionnaires. Moreover, participants were asked to record the number of falls they had over the next two years after the end of the training program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Postural BalanceAgedAccidental FallsFear of fallingPhysical FitnessResistance TrainingElastic Resistance

Outcome Measures

Primary Outcomes (7)

  • Change in fear of falling (Short FES-I score)

    Fear of falling will be assessed using the Short Falls Efficacy Scale-International (Short FES-I), a 7-item self-administered questionnaire that evaluates concern about falling during basic and social daily activities. Each item is rated on a 4-point scale (1 = not at all concerned to 4 = very concerned), yielding a total score from 7 to 28, with higher scores indicating greater fear of falling. Scores will be analysed as a continuous variable and, secondarily, categorized into low concern (7-8) versus moderate/high concern (≥9).

    Baseline and after 6 weeks of intervention

  • Lower-limb strength/endurance

    Lower-limb strength and endurance will be measured using the 30-second chair stand test from the Senior Fitness Test battery, recording the number of full stands completed from a seated position in 30 seconds.

    Baseline and after 6 weeks of intervention

  • Upper-limb strength

    Upper-limb strength will be assessed with the arm curl test from the Senior Fitness Test, counting the number of elbow flexion-extension repetitions completed in 30 seconds with a standardized hand weight.

    Baseline and after 6 weeks of intervention

  • Change in lower-back and hamstring flexibility

    Flexibility of the lower back and hamstrings will be evaluated using the chair sit-and-reach test from the Senior Fitness Test, recording the distance (cm) between the extended fingers and the tip of the toe while seated.

    Baseline and after 6 weeks of intervention

  • Change in dynamic balance and mobility

    Dynamic balance and functional mobility will be measured with the Timed Up and Go test, timing in seconds how long the participant takes to stand up from a chair, walk 3 meters, turn, walk back, and sit down.

    Baseline and after 6 weeks of intervention

  • Change in aerobic endurance

    Aerobic endurance will be assessed using the 2-minute step test, counting the number of steps performed in place at a standardized knee height over 2 minutes, as part of the Senior Fitness Test battery.

    Baseline and after 6 weeks of intervention

  • Relative Fall Risk

    Participants were asked to record the number of falls they had over the next two years after the end of the training program and relative fall risk was calculated.

    Over the next two years after the end of the training program

Secondary Outcomes (1)

  • Change in self-reported physical activity

    Baseline and after 6 weeks of intervention

Study Arms (2)

Resistance Training group (RT)

EXPERIMENTAL

Participants in the Resistance Training group (RT) underwent a supervised, structured resistance training program using elastic bands, targeting the major muscle groups of the upper and lower limbs. The program was designed to progressively enhance lower-limb strength and dynamic balance through sessions including warm-up, music-based resistance exercises, and cool-down phases, ultimately aiming to reduce fall risk.

Behavioral: Elastic-band resistance training

Balance and Strength group (BS)

EXPERIMENTAL

Participants in the Balance and Strength group (BS) took part in a supervised multi-station circuit combining bodyweight strengthening exercises with tasks that challenge dynamic balance (e.g., directional changes, stepping, and weight-shifting activities). The program progressively increased in difficulty across sessions to enhance postural control and dynamic stability, aiming to improve balance efficiency and reduce fall risk.

Behavioral: Functional and balance circuit training

Interventions

Supervised group-based resistance training with elastic bands, targeting major upper- and lower-limb muscle groups. Sessions include warm-up, a structured resistance phase with music-based exercises, and cool-down, with progressive increases in band resistance and exercise volume to improve lower-limb strength, dynamic balance, and reduce fall risk.

Resistance Training group (RT)

Supervised multistation circuit combining bodyweight strengthening exercises and dynamic balance tasks (e.g., directional changes, stepping, and weight-shifting activities). Sessions include warm-up, one or two rounds of the circuit, and cool-down, with progressive increases in task complexity to enhance postural control, dynamic stability, and reduce fall risk.

Balance and Strength group (BS)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older Adults;
  • Age ≥ 60 years;
  • Independent in carrying out activities of daily living.

You may not qualify if:

  • Unstable cardiovascular, respiratory, or neurological conditions that contraindicate exercise;
  • Recent fractures, major orthopedic surgery, or acute musculoskeletal pain limiting safe exercise participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, Sicily, 90144, Italy

Location

Related Publications (1)

  • Bellafiore M, Battaglia G, Bianco A, Paoli A, Farina F, Palma A. Improved postural control after dynamic balance training in older overweight women. Aging Clin Exp Res. 2011 Oct-Dec;23(5-6):378-85. doi: 10.1007/BF03337762. Epub 2010 Nov 17.

    PMID: 21084833BACKGROUND

MeSH Terms

Interventions

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily LivingRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 29, 2026

Study Start

November 1, 2022

Primary Completion

May 30, 2024

Study Completion

May 30, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations