Design and Validation of FEXO: A Playful Exercise Program for Institutionalized Frail Older Adults (FEXO-FRAIL)

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Frailty Syndrome
• Intervention / Treatment: Other: FEXO (Fun Exercise for Older Adults)

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46115
    • Universidad CEU Cardenal Herrera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrinsic Capacity (IC)	This composite outcome evaluates changes in intrinsic capacity, following the five-domain model proposed by the World Health Organization: cognition, vitality, locomotion (function), sensory function, and psychological well-being. Each domain is assessed through one standardized test: the Mini-Mental State Examination (MMSE) for cognition, the Mini Nutritional Assessment (MNA) for vitality, the Short Physical Performance Battery (SPPB) for locomotion, self-reported vision and hearing for sensory function, and the Cornell Scale for Depression in Dementia (CSDD) for psychological well-being. Each test contributes up to a maximum of 2 points, according to predefined cut-off values. For the cognitive domain (MMSE), 2 points are assigned if ≥27, 1 point if 10-26, and 0 points if 0-9. For vitality (MNA), 2 points are assigned if 24-30, 1 point if 17-23, and 0 points if <17. For locomotion (SPPB), 2 points are assigned if ≥10, 1 point if 3-9, and 0 points if 0-2. For sensory function (self-r	Before and inmediately after the intervention
Frailty (Fried's Phenotype)	Frailty status will be assessed using Fried's phenotype, which classifies participants as robust (0 criteria), pre-frail (1-2 criteria), or frail (3-5 criteria) based on five components: unintentional weight loss, exhaustion, low physical activity, slow gait speed, and weak grip strength. Improvement is defined as transition to a lower frailty category (e.g., from frail to pre-frail).	Before and inmediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery (SPPB)	The SPPB evaluates lower-extremity function through three subtests: standing balance (performed with feet together, semi-tandem, and tandem), gait speed over a 4-meter distance, and a five-times sit-to-stand test. Each subtest is scored from 0 to 4, for a total score ranging from 0 to 12. Higher scores indicate better physical performance. The SPPB is predictive of disability, hospitalization, and mortality in older adults.	Before and inmediately after the intervention
Timed Up and Go Test (TUG)	This test assesses functional mobility and risk of falling. Participants are instructed to rise from a standard chair, walk 3 meters, turn around, walk back, and sit down. The total time (in seconds) is recorded. Lower times indicate better mobility and balance. The TUG has high predictive value for fall risk in frail older populations.	Before and inmediately after the intervention
Grip Strength (JAMAR Dynamometer)	Grip strength will be measured using a JAMAR hand dynamometer, with participants seated, the elbow at 90°, forearm in a neutral position, and wrist slightly extended. The best of three trials is recorded in kilograms. Grip strength is a core indicator of sarcopenia and a strong predictor of functional decline, morbidity, and mortality. Higher values reflect better upper-limb muscle strength.	Before and inmediately after the intervention
10-Meter Walk Test (10-MWT)	Participants will perform two walking trials over 10 meters: one at habitual pace and one at maximum pace. The time to walk the central 6-meter portion is recorded and converted into meters per second (m/s). Gait speed is a validated marker of frailty, physical function, and fall risk. Higher walking speeds reflect better functional status.	Before and inmediately after the intervention
Mini-Mental State Examination (MMSE)	The MMSE evaluates general cognitive status through domains including orientation, memory, attention, language, and visuospatial skills. It yields a score from 0 to 30, with higher scores indicating better cognitive function. It is widely used for screening and monitoring cognitive impairment in older adults.	Before and inmediately after the intervention
Mini Nutritional Assessment (MNA)	The MNA is a validated tool for detecting malnutrition or risk of malnutrition in older adults. It includes 18 items covering anthropometry, general health, dietary intake, and subjective assessment. Total scores range from 0 to 30: scores ≥24 indicate normal nutrition, 17-23.5 suggest risk of malnutrition, and <17 indicate malnutrition. Higher scores reflect better nutritional status.	Before and inmediately after the intervention
Geriatric Depression Scale (GDS)	The GDS short form (15 items) will be used to screen for depressive symptoms in participants. Responses are binary (yes/no), and total scores are calculated. Higher scores indicate more depressive symptoms; scores >5 may indicate clinical depression. Lower scores represent better psychological well-being.	Before and inmediately after the intervention
Berg Balance Scale (BBS)	This 14-item scale assesses balance and postural control in older adults. Each task (e.g., standing, reaching, turning) is scored from 0 (unable) to 4 (independent), with a total score ranging from 0 to 56. Scores below 45 suggest increased fall risk. Higher scores reflect better balance.	Before and inmediately after the intervention
Barthel Index	This scale measures independence in 10 basic activities of daily living (ADLs), including feeding, grooming, bathing, dressing, bowel and bladder control, toilet use, transfers, mobility, and stair use. Scores range from 0 to 100, with higher scores indicating greater functional independence. The index is commonly used in geriatric and rehabilitation settings.	Before and inmediately after the intervention
Cornell Scale for Depression in Dementia	The Cornell Scale for Depression in Dementia (CSDD) will be used to assess depressive symptoms in participants with or without cognitive impairment. The scale consists of 19 items covering mood-related signs, behavioral disturbances, physical signs, cyclic functions, and ideational disturbances. Each item is rated from 0 to 2 (0 = absent, 1 = mild or intermittent, 2 = severe), based on interviews with both the patient and an informant. Total scores range from 0 to 38, with higher scores indicating more severe depressive symptoms. Scores above 10 suggest probable major depression, while scores above 18 are highly indicative of a depressive disorder. Lower scores represent better psychological well-being.	Before and inmediately after the intervention
Self-reported Vision	Self-reported vision will be assessed through a single-item question asking participants to rate their visual ability. Responses are scored as follows: 0 = severe difficulty or complete blindness, 0.5 = mild to moderate difficulty, and 1 = no difficulty. Higher scores indicate better sensory function.	Before and inmediately after the intervention
Self-reported Hearing	Self-reported hearing will be assessed through a single-item question asking participants to rate their hearing ability. Responses are scored as follows: 0 = severe difficulty or complete deafness, 0.5 = mild to moderate difficulty, and 1 = no difficulty. Higher scores indicate better sensory function.	Before and inmediately after the intervention

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Investigators: Principal Investigator: Juan Francisco Lisón Párraga, Dr, Cardenal Herrera University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Actual): December 19, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: August 20, 2025
• First Posted (Actual): August 21, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: frailty; sarcopenia; multicomponent exercise; intrinsic capacity; Institutionalized older adults; playful exercise
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Sarcopenia; Physiological Phenomena; Growth and Development; Aging
• Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-98

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No