- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555249
Comparative Effects Between a Resistance Training and a Combined Balance and Strength Training on Functional Fitness and Fall Risk in Older Adults
Effects of Resistance Training Versus Combined Dynamic Balance and Strength Training on Functional Fitness and Fall Risk in Older Adults. A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sicily
-
Palermo, Sicily, Italy, 90144
- University of Palermo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance Training group (RT)
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.
|
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.
|
|
Experimental: Balance and Strength group (BS)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline and after 6 weeks of intervention
|
|
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.
|
Baseline and after 6 weeks of intervention
|
|
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.
|
Baseline and after 6 weeks of intervention
|
|
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.
|
Baseline and after 6 weeks of intervention
|
|
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.
|
Baseline and after 6 weeks of intervention
|
|
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.
|
Baseline and after 6 weeks of intervention
|
|
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.
|
Over the next two years after the end of the training program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline and after 6 weeks of intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Accidental Fall
-
Aalborg University HospitalCompleted
-
University of AmsterdamCompletedDeprescribing | Fall | Fall Injury | Fall Patients | Accidental FallNetherlands
-
Rush University Medical CenterWestern Michigan UniversityCompletedFall, Accidental | Fall AccidentUnited States
-
Betul Esra CevikCompletedAccidental Fall | Fall Prevention | Fall Risk FactorsTurkey (Türkiye)
-
CUSH Health Ltd.University of SussexNot yet recruitingAccidental Fall
-
Virginia Polytechnic Institute and State UniversityCompleted
-
National Opinion Research CenterCenters for Disease Control and Prevention; Emory HealthcareCompleted
-
Escola Superior de Tecnologia da Saúde de CoimbraSensing Future Technologies; Fraunhofer Portugal Research Center for Assistive...UnknownAccidental FallPortugal
-
MedicusTek, IncCompletedPatient Fall | Accidental Fall From BedTaiwan
-
Washington University School of MedicineUS Department of Housing and Urban DevelopmentCompleted
Clinical Trials on Elastic-band resistance training
-
Lou QingqingCompleted
-
Chang Bing Show Chwan Memorial HospitalUnknown
-
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical...CompletedBody Weight Changes | Sarcopenia | Prader Labhart Willi SyndromeTaiwan
-
China Medical University HospitalCompleted
-
University of MichiganEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAnterior Cruciate Ligament InjuryUnited States
-
Khyber Medical University PeshawarCompleted
-
Zhejiang Rongjun HospitalCompleted
-
The University of Hong KongHospital Authority, Hong KongRecruiting
-
University of ValenciaGeneralitat Valenciana; Indiex Sport Nutrition Spail SLActive, not recruitingPhysical Activity | Aging | TrainingSpain
-
Prince of Songkla UniversityCompleted