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Completed

NCT Number: NCT07555249

Comparative Effects Between a Resistance Training and a Combined Balance and Strength Training on Functional Fitness and Fall Risk in Older Adults

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Palermo

Palermo, Sicily, 90144, Italy

About this study

This randomized controlled trial was conducted within the Physical Activity Promotion Domestic and Accidents Prevention (PAP & DAP) project in older adults. A total of 110 participants aged 65-85 years, independent and physically active, were randomly allocated to one of two supervised exercise programs: a resistance training (RT) group using elastic bands and a combined balance and strength (BS) group following a multi-station circuit of body-weight strengthening tasks and dynamic balance exercises. Both interventions lasted 6 weeks, with two sessions per week (3 hours/week), and all sessions were carried out by qualified exercise professionals.

Functional fitness was assessed before and after the intervention using the Senior Fitness Test battery (chair stand, arm curl, sit-and-reach, back scratch, timed up-and-go, and two-minute step test). Fear of falling was evaluated with the Short Falls Efficacy Scale-International (Short FES-I), and physical activity levels were measured using the International Physical Activity Questionnaire for Italian Elderly (IPAQ-EIT). Falls history was collected at baseline (previous 12 months), and the occurrence of at least one fall was recorded at 1- and 2-year follow-up, allowing estimation of fall incidence and crude risk ratios between groups.

The RT program focused on progressive resistance exercises for major upper- and lower-limb muscle groups using elastic bands, organized into a standardized warm-up, central training phase, and cool-down, with progression in band resistance over the 6 weeks. The BS program consisted of a fixed-order multi-station circuit including gait, stepping, and weight-shifting tasks designed to challenge vestibular, visual, muscular, and plantar components of balance, combined with lower-limb strengthening exercises. Both protocols were designed to be feasible in community settings and to target key determinants of functional independence and fall risk in older adults.

Analyses included repeated-measures ANOVA to examined significant differences within and between groups, correlations among gain scores in functional fitness variables and fear of falling, and calculation of fall incidence and risk ratios at follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Elastic-band resistance training

Behavioral

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.

Functional and balance circuit training

Behavioral

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.

Primary outcomes

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

    Time frame: Baseline and after 6 weeks of intervention

    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).

  2. Lower-limb strength/endurance

    Time frame: Baseline and after 6 weeks of intervention

    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.

  3. Upper-limb strength

    Time frame: Baseline and after 6 weeks of intervention

    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.

  4. Change in lower-back and hamstring flexibility

    Time frame: Baseline and after 6 weeks of intervention

    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.

  5. Change in dynamic balance and mobility

    Time frame: Baseline and after 6 weeks of intervention

    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.

  6. Change in aerobic endurance

    Time frame: Baseline and after 6 weeks of intervention

    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.

  7. Relative Fall Risk

    Time frame: Over the next two years after the end of the training program

    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.

Secondary outcomes

  1. Change in self-reported physical activity

    Time frame: Baseline and after 6 weeks of intervention

    Self-reported physical activity will be assessed using the 7-item International Physical Activity Questionnaire for the Italian Elderly (IPAQ-EIT), which records the number of days and minutes spent walking, and in moderate and vigorous activities, as well as sedentary time over the previous week. For each intensity level, a specific MET value is assigned (walking = 3.3 METs, moderate activity = 4 METs, vigorous activity = 8 METs), and total physical activity is expressed as MET-minutes per week by summing the three components. According to total MET-minutes/week, participants will be classified as inactive (<700 MET-min/week), sufficiently active (700-2519 MET-min/week), or active/very active (≥2520 MET-min/week).

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Effects of Resistance Training Versus Combined Dynamic Balance and Strength Training on Functional Fitness and Fall Risk in Older Adults. A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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