Fun Exercise Intervention for Older Adults to Improve Intrinsic Capacity and Motivation

NCT ID: NCT07133568

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-04
• Study Completion Date: 2025-12-31

Brief Summary

This randomized clinical trial aims to evaluate the effectiveness of a structured, multicomponent recreational exercise program (FEXO: Fun Exercise for Older Adults) in improving intrinsic capacity, motivation, and adherence among community-dwelling older adults. Participants aged 60 years and older will be randomly allocated to either the FEXO group or a control group performing the established OTAGO program. The intervention will last 14 weeks, with three weekly sessions. Assessments will be conducted at baseline, post-intervention, and after a 3-month follow-up.

Detailed Description

The global increase in the aging population poses significant public health and societal challenges, particularly regarding multimorbidity, frailty, and functional decline. In response, the World Health Organization has introduced the concept of Intrinsic Capacity (IC), which encompasses the physical and mental capacities an individual can draw upon. IC includes five domains: locomotion, vitality, cognition, psychological well-being, and sensory function.

Evidence supports multicomponent exercise as a primary strategy to promote healthy aging and preserve functionality in older adults. However, low adherence and motivation remain critical barriers. This study proposes a novel, recreationally oriented multicomponent program-FEXO-designed to increase engagement through fun, low-cost, group-based sessions adapted to functional levels.

The study is a two-arm, parallel-group, randomized clinical trial with a 2:1 allocation ratio (intervention:control). A total of 122 older adults from the community will be recruited and randomized into either the FEXO group or the control group (OTAGO program). Both interventions include three non-consecutive weekly sessions over 14 weeks. The FEXO program includes a familiarization phase and progressive intensity adjustments.

Sessions integrate strength, balance, coordination, cognitive stimulation, and relaxation in a recreational format using music, elastic bands, and playful materials. Primary outcomes include changes in Intrinsic Capacity, assessed through standardized tools across its five domains. Secondary outcomes include anthropometric data, cardiovascular parameters, physical performance tests, cognitive function, depression, resilience, and exercise motivation. Adherence will be tracked as the percentage of sessions attended.

Statistical analysis will be conducted on an intention-to-treat basis using two-way ANOVA, with effect sizes and confidence intervals reported. The study has been approved by the Ethics Committee of CEU Cardenal Herrera University and complies with the Declaration of Helsinki.

Conditions

Sarcopenia; Frailty Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FEXO (Fun EXercise for Older adults)

Participants assigned to the experimental group will take part in a structured multicomponent exercise program specifically designed for older adults. The program, named FEXO, emphasizes recreational and motivational aspects to enhance adherence and enjoyment. It consists of three non-consecutive 1-hour sessions per week for 14 weeks. Exercises are conducted in a group setting (maximum ratio 1 instructor to 15 participants) and are progressively adapted according to the functional capacity of each participant, assessed using the Short Physical Performance Battery (SPPB).

The program uses simple, low-cost, portable materials such as elastic bands, chairs, soft balls, scarves, maracas, and a bubble machine, creating a playful and inclusive environment.

Group Type: EXPERIMENTAL

Fun Exercise for Older Adults (FEXO)

Intervention Type: OTHER

The FEXO (Fun Exercise for Older Adults) program is a 14-week, multicomponent, recreational exercise intervention designed to enhance intrinsic capacity, motivation, and adherence in community-dwelling older adults. Participants engage in three non-consecutive, supervised group sessions per week (maximum instructor-to-participant ratio 1:15), each lasting approximately 60 minutes. The program begins with a two-week familiarization phase followed by three progressive phases (4 weeks each), with exercise intensity, repetitions, and resistance levels adjusted based on functional performance assessed by the Short Physical Performance Battery (SPPB).

OTAGO multicomponent exercise program

Participants in the control group will follow the OTAGO Exercise Program, a widely studied and evidence-based intervention aimed at reducing fall risk and improving lower-limb strength and balance in older adults. This program also lasts 14 weeks, with three non-consecutive sessions per week, delivered in a group format under the supervision of a physiotherapist.

Unlike the FEXO program, OTAGO is more traditional and does not include recreational or cognitive stimulation elements. It serves as an active comparator to evaluate whether incorporating fun and motivational strategies improves adherence, engagement, and intrinsic capacity.

Group Type: ACTIVE_COMPARATOR

OTAGO

Intervention Type: OTHER

The OTAGO Exercise Program is a structured, evidence-based intervention developed to improve lower-limb strength and balance and reduce fall risk in older adults. In this study, participants in the control group will complete three non-consecutive, supervised sessions per week for a total duration of 14 weeks. Sessions will be delivered in group settings under the supervision of a licensed physiotherapist. The program includes individualized strength training for the lower extremities, progressive balance exercises, and walking routines. Although originally designed as a home-based program, in this trial it will be implemented in indoor, climate-controlled, non-slip-floor facilities provided by local institutions. The OTAGO protocol does not include recreational, cognitive, or playful components, serving instead as a standard, structured intervention against which the FEXO program will be compared.

Interventions

Fun Exercise for Older Adults (FEXO)

The FEXO (Fun Exercise for Older Adults) program is a 14-week, multicomponent, recreational exercise intervention designed to enhance intrinsic capacity, motivation, and adherence in community-dwelling older adults. Participants engage in three non-consecutive, supervised group sessions per week (maximum instructor-to-participant ratio 1:15), each lasting approximately 60 minutes. The program begins with a two-week familiarization phase followed by three progressive phases (4 weeks each), with exercise intensity, repetitions, and resistance levels adjusted based on functional performance assessed by the Short Physical Performance Battery (SPPB).

Intervention Type: OTHER

OTAGO

The OTAGO Exercise Program is a structured, evidence-based intervention developed to improve lower-limb strength and balance and reduce fall risk in older adults. In this study, participants in the control group will complete three non-consecutive, supervised sessions per week for a total duration of 14 weeks. Sessions will be delivered in group settings under the supervision of a licensed physiotherapist. The program includes individualized strength training for the lower extremities, progressive balance exercises, and walking routines. Although originally designed as a home-based program, in this trial it will be implemented in indoor, climate-controlled, non-slip-floor facilities provided by local institutions. The OTAGO protocol does not include recreational, cognitive, or playful components, serving instead as a standard, structured intervention against which the FEXO program will be compared.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Community-dwelling adults aged 60 years or older.
• Able to walk independently, with or without assistive devices (e.g., cane or walker).
• Provide written informed consent before participation.
• Willing and able to attend scheduled exercise sessions and assessments over the full duration of the study.

Exclusion Criteria

• Presence of severe psychiatric or psychological disorders that may interfere with participation or adherence.
• Physical incapacity to perform moderate-intensity exercise safely.
• Participation in another structured multicomponent exercise program during the intervention period.
• Cognitive impairment that limits comprehension or execution of instructions, as determined by clinical evaluation.
• Recent fractures, or uncontrolled cardiovascular conditions that contraindicate exercise.
• Any medical condition judged by the investigators to contraindicate physical exercise or to pose an unacceptable risk.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Lisón Párraga, Dr

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Francisco Lisón Párraga, Dr

Role: PRINCIPAL_INVESTIGATOR

Cardenal Herrera University

Locations

Universidad Ceu Cardenal Herrera

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

JF Lisón, Dr

Role: CONTACT

juanfran@uchceu.es

0034606503108

Vicente Benavent-Caballer, Dr

Role: CONTACT

vicente.benvanet@uchceu.es

Facility Contacts

Pedro Azañón

Role: primary

pedro.azanonnogueira@uchceu.es

+34603660954

Other Identifiers

UNIVERSITY CARDENAL HERRERA-77

Identifier Type: -

Identifier Source: org_study_id