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

NCT07133581 | Completed

• 1 other identifier: UNIVERSITY CARDENAL HERRERA-98
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Frailty Syndrome

Keywords

frailty; sarcopenia; intrinsic capacity; Institutionalized older adults; playful exercise; multicomponent exercise

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Short Physical Performance Battery (SPPB)

  Before and inmediately after the intervention

• Timed Up and Go Test (TUG)

  Before and inmediately after the intervention

• Grip Strength (JAMAR Dynamometer)

  Before and inmediately after the intervention

• 10-Meter Walk Test (10-MWT)

  Before and inmediately after the intervention

• Mini-Mental State Examination (MMSE)

  Before and inmediately after the intervention

Study Arms (2)

Wait-List Control Group

NO INTERVENTION

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.

FEXO Multicomponent Playful Exercise

EXPERIMENTAL

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)

Interventions

FEXO (Fun Exercise for Older Adults) 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.

FEXO Multicomponent Playful Exercise

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, 46115, Spain

Location

MeSH Terms

Conditions

Frailty; Sarcopenia

Interventions

Aging

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Juan Francisco Lisón Párraga, Dr

  Cardenal Herrera University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 21, 2025
• Study Start: September 4, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 31, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

ES (1)