Fun Exercise Intervention for Older Adults to Improve Intrinsic Capacity and Motivation
FEXO-COM
Design, Development, and Validation of a Recreational Exercise Intervention in Older Adults to Improve Intrinsic Capacity and Motivation: A Randomized Clinical Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2025
CompletedFirst Posted
Study publicly available on registry
August 21, 2025
CompletedStudy Start
First participant enrolled
September 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 8, 2026
April 1, 2026
4 months
July 25, 2025
April 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Intrinsic Capacity
It is a multidimensional concept defined by the World Health Organization to represent the total physical and mental capacities of an individual. It includes five domains: locomotion (SPPB), vitality (MDA), cognition (MMSE), psychological well-being (CSDD), and sensory function (Self-reported). Each domain contributes up to 2 points, for a total composite score ranging from 0 to 10. Higher scores indicate better intrinsic capacity and functional reserve. The specific instruments used to assess each domain are standard, validated tools, and although they contribute to the IC score, they will also be analyzed separately as secondary outcomes to better understand changes in each specific domain.
Before and inmediately after the intervention
Adherence to intervention
Adherence will be calculated as the percentage of sessions attended out of the total planned (42 sessions over 14 weeks). Higher adherence rates reflect better feasibility and acceptance of the exercise program.
During intervention
Motivation (Behavioral Regulation in Exercise Questionnaire (BREQ-3))
This self-report questionnaire assesses different types of motivation toward exercise (intrinsic, identified, introjected, external, and amotivation) based on Self-Determination Theory. Each subscale ranges from 0 to 12 points. Higher scores in intrinsic and identified motivation are considered positive indicators of adherence and engagement, whereas higher scores in introjected, external, and amotivation reflect lower quality motivation and are considered unfavorable.
Before and inmediately after the intervention
Secondary Outcomes (19)
Blood pressure
Before and inmediately after the intervention
Heart rate
Before and inmediately after the intervention
Frailty status (Fried criteria)
Before and inmediately after the intervention
Grip Strenght (JAMAR Dynamometer)
Before and inmediately after the intervention
10-Meter Walk Test (10-MWT)
Before and inmediately after the intervention
- +14 more secondary outcomes
Study Arms (2)
FEXO (Fun EXercise for Older adults)
EXPERIMENTALParticipants 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.
OTAGO multicomponent exercise program
ACTIVE COMPARATORParticipants 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.
Interventions
The FEXO (Fun Exercise for Older Adults) program is a 14-week, multicomponent, recreational exercise intervention designed to enhance intrinsic capacity, motivation, and adherence in community-dwelling older adults. Participants engage in three non-consecutive, supervised group sessions per week (maximum instructor-to-participant ratio 1:15), each lasting approximately 60 minutes. The program begins with a two-week familiarization phase followed by three progressive phases (4 weeks each), with exercise intensity, repetitions, and resistance levels adjusted based on functional performance assessed by the Short Physical Performance Battery (SPPB).
The OTAGO Exercise Program is a structured, evidence-based intervention developed to improve lower-limb strength and balance and reduce fall risk in older adults. In this study, participants in the control group will complete three non-consecutive, supervised sessions per week for a total duration of 14 weeks. Sessions will be delivered in group settings under the supervision of a licensed physiotherapist. The program includes individualized strength training for the lower extremities, progressive balance exercises, and walking routines. Although originally designed as a home-based program, in this trial it will be implemented in indoor, climate-controlled, non-slip-floor facilities provided by local institutions. The OTAGO protocol does not include recreational, cognitive, or playful components, serving instead as a standard, structured intervention against which the FEXO program will be compared.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Ceu Cardenal Herrera
Valencia, 46115, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Francisco Lisón Párraga, Dr
Cardenal Herrera University
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 8, 2026
Record last verified: 2026-04