NCT07133581

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

Design, Development, and Validation of FEXO: A Playful-Recreational Exercise Intervention for Institutionalized Frail Older Adults to Improve Intrinsic Functional and Cognitive Capacity: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Cardenal Herrera University · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-09-04
• Primary completion: 2025-12-19
• Completion: 2025-12-31
• First posted: 2025-08-21
• Last updated: 2026-04-08

Locations

1 site across 1 country: Spain