Design and Validation of FEXO: A Playful Exercise Program for Institutionalized Frail Older Adults

NCT ID: NCT07133581

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-04
• Study Completion Date: 2025-12-31

Brief Summary

This multicenter randomized controlled trial aims to evaluate the effectiveness of a playful multicomponent exercise intervention (FEXO - Fun Exercise for Older Adults) on intrinsic capacity, frailty, and functional health in institutionalized older adults aged over 75. The FEXO program combines aerobic, strength, balance, and flexibility training in a recreational format. Participants will be randomized to an experimental group (receiving the 14-week FEXO program) or a wait-list control group (continuing daily routines). After the first intervention phase, the control group will also complete the program. Primary outcomes include improvements in intrinsic capacity domains (cognition, locomotion, vitality, sensory, and psychological), frailty phenotype (Fried criteria), and physical function.

Detailed Description

Frailty is a dynamic syndrome marked by diminished physiological reserves and increased vulnerability to stressors. It is prevalent among institutionalized older adults and is associated with higher risks of dependency, hospitalization, and reduced quality of life. Evidence shows that physical inactivity and sedentary behavior significantly contribute to the onset and progression of frailty, especially in long-term care settings.

The World Health Organization (WHO) introduced the concept of Intrinsic Capacity in 2015, emphasizing a multidimensional view of healthy aging that includes cognition, mobility, vitality, sensory function, and psychological well-being. Preserving or enhancing intrinsic capacity is critical to prolonging independence and life quality among older adults.

This trial assesses the effectiveness of the FEXO program, a playful multicomponent exercise intervention designed to enhance intrinsic capacity and reduce frailty in adults over 75 years of age residing in geriatric care centers of the Ballesol Group (Valencia and Alicante). The intervention combines aerobic, strength, balance, gait, and flexibility exercises delivered in a recreational and group-based format using playful tools (e.g., foam balls, scarves, bubbles). Participants will engage in three 55-60 minute sessions per week over 14 weeks.

The study follows a wait-list controlled randomized design. Participants will be randomized to one of two groups: (1) the experimental group, which receives the FEXO intervention immediately, and (2) the control group, which continues routine activities during the first 14 weeks, followed by delayed participation in the program. Outcomes will be measured at baseline (T0), post-intervention (T1, at 14 weeks), and follow-up (T2, 28 weeks post-baseline for the control group).

Primary and secondary outcomes include: Fried's Frailty Phenotype, Short Physical Performance Battery (SPPB), Timed Up and Go Test (TUG), grip strength (JAMAR), walking speed (10-MWT), cognitive status (MMSE), nutritional status (MNA), depressive symptoms (GDS, CSDD), balance (Berg Balance Scale), and quality of life indicators.

This trial responds to the need for evidence-based interventions in institutionalized elderly populations, supporting WHO guidelines for healthy aging and promoting holistic care by integrating physical activity into daily routines through enjoyable, motivating formats.

Conditions

Frailty Syndrome; Sarcopenia

Study Design

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

Study Groups

Wait-List Control Group

Participants in this group will continue their usual daily activities for 14 weeks without receiving the FEXO intervention. After this period, they will be offered the same 14-week FEXO program as the experimental group, following the same structure, supervision, and exercise content.

Group Type: NO_INTERVENTION

No interventions assigned to this group

FEXO Multicomponent Playful Exercise

Participants in this group will follow the FEXO program, a 14-week multicomponent playful-recreational exercise intervention. The program includes 3 supervised sessions per week (55-60 minutes each) and incorporates aerobic, resistance, balance, flexibility, and gait exercises delivered in a playful group-based format using motivational materials. The 14-week program is structured into an initial 2-week familiarization phase followed by three progressive 4-week levels. Exercises are adapted and progressively intensified according to individual capacity.

Group Type: EXPERIMENTAL

FEXO (Fun Exercise for Older Adults)

Intervention Type: OTHER

A 14-week supervised multicomponent playful exercise program for institutionalized older adults. It consists of 3 sessions per week (55-60 minutes), including aerobic, strength, balance, flexibility, and gait exercises in a group-based, game-like setting. The structure includes 2 weeks of familiarization followed by 3 progressive 4-week levels. The intervention aims to improve intrinsic capacity, reduce frailty, and enhance physical and cognitive function.

Interventions

FEXO (Fun Exercise for Older Adults)

A 14-week supervised multicomponent playful exercise program for institutionalized older adults. It consists of 3 sessions per week (55-60 minutes), including aerobic, strength, balance, flexibility, and gait exercises in a group-based, game-like setting. The structure includes 2 weeks of familiarization followed by 3 progressive 4-week levels. The intervention aims to improve intrinsic capacity, reduce frailty, and enhance physical and cognitive function.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥75 years.
• Resident in a long-term care facility (residencia geriátrica) affiliated with the Ballesol group (Levante area: Valencia and Alicante).
• Provide informed consent (or consent by legal representative, if appropriate).
• Functional and/or cognitive status that allows them to participate in basic physical activity and understand and follow basic verbal instructions.

Exclusion Criteria

• Unstable medical condition or uncontrolled chronic disease.
• Severe cognitive impairment or advanced dementia that prevents comprehension or adherence to the intervention, determined by clinical assessment or MMSE <15.
• Severe physical disability.
• Active infectious disease or acute condition requiring isolation or rest.
• Participation in another structured physical activity or rehabilitation program during the study period.
• End-of-life situation or terminal illness.
• Any condition that, in the judgment of the research or clinical team, would interfere with participation or data collection.

• Minimum Eligible Age: 75 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

Central Contacts

JF Lisón, Dr

Role: CONTACT

juanfran@uchceu.es

0034606503108

Vicente Benavent-Caballer, Dr

Role: CONTACT

vicente.benvanet@uchceu.es

Other Identifiers

UNIVERSITY CARDENAL HERRERA-98

Identifier Type: -

Identifier Source: org_study_id