Fun Exercise Intervention for Older Adults to Improve Intrinsic Capacity and Motivation (FEXO-COM)

Cardenal Herrera University

Status: Enrolling

Conditions: Frailty Syndrome; Sarcopenia

Treatments: Other: OTAGO; Other: Fun Exercise for Older Adults (FEXO)

Study type: Interventional

Funder types: Other

Identifiers

NCT07133568

UNIVERSITY CARDENAL HERRERA-77

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

FEXO (Fun EXercise for Older adults)

Experimental group

Description:

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.

Treatment:

Other: Fun Exercise for Older Adults (FEXO)

OTAGO multicomponent exercise program

Active Comparator group

Description:

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.

Treatment:

Other: OTAGO