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SarcopeniaFEXO-COMNCT07133568

Fun Exercise Intervention for Older Adults to Improve Intrinsic Capacity and Motivation

A study testing Fun Exercise for Older Adults (FEXO) and OTAGO in people with Sarcopenia and Frailty Syndrome, run by Cardenal Herrera University at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Frailty Syndrome
What is being tested?
Fun Exercise for Older Adults (FEXO) and OTAGO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
4 Sep 2025to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad Ceu Cardenal Herrera

    Valencia, 46115

Other trials in Spain

About this study

Official title: Design, Development, and Validation of a Recreational Exercise Intervention in Older Adults to Improve Intrinsic Capacity and Motivation: A Randomized Clinical Trial

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.

Read the detailed description

The global increase in the aging population poses significant public health and societal challenges, particularly regarding multimorbidity, frailty, and functional decline. In response, the World Health Organization has introduced the concept of Intrinsic Capacity (IC), which encompasses the physical and mental capacities an individual can draw upon. IC includes five domains: locomotion, vitality, cognition, psychological well-being, and sensory function.

Evidence supports multicomponent exercise as a primary strategy to promote healthy aging and preserve functionality in older adults. However, low adherence and motivation remain critical barriers. This study proposes a novel, recreationally oriented multicomponent program-FEXO-designed to increase engagement through fun, low-cost, group-based sessions adapted to functional levels.

The study is a two-arm, parallel-group, randomized clinical trial with a 2:1 allocation ratio (intervention:control). A total of 122 older adults from the community will be recruited and randomized into either the FEXO group or the control group (OTAGO program). Both interventions include three non-consecutive weekly sessions over 14 weeks. The FEXO program includes a familiarization phase and progressive intensity adjustments.

Sessions integrate strength, balance, coordination, cognitive stimulation, and relaxation in a recreational format using music, elastic bands, and playful materials. Primary outcomes include changes in Intrinsic Capacity, assessed through standardized tools across its five domains. Secondary outcomes include anthropometric data, cardiovascular parameters, physical performance tests, cognitive function, depression, resilience, and exercise motivation. Adherence will be tracked as the percentage of sessions attended.

Statistical analysis will be conducted on an intention-to-treat basis using two-way ANOVA, with effect sizes and confidence intervals reported. The study has been approved by the Ethics Committee of CEU Cardenal Herrera University and complies with the Declaration of Helsinki.

Being tested
Fun Exercise for Older Adults (FEXO), OTAGO
Keywords
intrinsic capacity, fun exercise, playful exercise, frailty, multicomponent exercise, otago
Medical subject headings
Sarcopenia, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fun Exercise for Older Adults (FEXO)Other

    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).

  • OTAGOOther

    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.

Study groups in NCT07133568
Study groupRoleWhat they receive
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.
Receives: Other: Fun Exercise for Older Adults (FEXO)
OTAGO multicomponent exercise programActive 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.
Receives: Other: OTAGO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before and inmediately after the intervention

  2. 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.

    Measured: During intervention

  3. 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.

    Measured: Before and inmediately after the intervention

Secondary outcomes (19)
  1. Blood pressure

    Resting systolic and diastolic blood pressure will be measured at all three time points using an automated sphygmomanometer, following the European Society of Hypertension guidelines. A reduction or maintenance within normal ranges (<130/80 mmHg) is considered a favorable outcome, while elevated values or increases over time indicate an unfavorable outcome.

    Measured: Before and inmediately after the intervention

  2. Heart rate

    Resting heart rate (beats per minute) will be assessed at all three time points using an automated sphygmomanometer, following the European Society of Hypertension guidelines. A reduction or maintenance within normal ranges (60-80 bpm) is considered a favorable outcome, whereas elevated resting heart rate (>80 bpm) or increases across assessments are considered unfavorable.

    Measured: Before and inmediately after the intervention

  3. Frailty status (Fried criteria)

    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).

    Measured: Before and inmediately after the intervention

  4. Grip Strenght (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.

    Measured: Before and inmediately after the intervention

  5. 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.

    Measured: Before and inmediately after the intervention

  6. 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.

    Measured: Before and inmediately after the intervention

  7. 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.

    Measured: Before and inmediately after the intervention

  8. Geriatric Depression Scale (GDS)

    The Geriatric Depression Scale short form (15 items) will be used to screen for depressive symptoms in participants. Responses are binary (yes/no), and total scores range from 0 to 15. A score of 0 indicates no depressive symptoms (best psychological well-being), while 15 indicates the maximum level of depressive symptoms. Scores >5 may indicate clinical depression.

    Measured: Before and inmediately after the intervention

  9. 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.

    Measured: Before and inmediately after the intervention

  10. Sit-to-Stand Test (STS-5)

    The Five-Times Sit-to-Stand test evaluates lower-limb strength and endurance. The time in seconds to complete five sit-to-stand repetitions without arm support is measured. Shorter times reflect better muscle function and physical performance.

    Measured: Before and inmediately after the intervention

  11. Timed Up and Go (TUG) - Standard version

    The standard Timed Up and Go (TUG) test is a widely used functional assessment that measures basic mobility and dynamic balance. Participants are instructed to stand up from a standard-height chair, walk a distance of 3 meters, turn around, return to the chair, and sit down. The total time required to complete the task is recorded in seconds. Shorter times indicate better functional mobility and lower risk of falls.

    Measured: Before and inmediately after the intervention

  12. Trail Making Test - Part A

    This test measures visual attention, processing speed, and cognitive flexibility. Participants are instructed to connect a sequence of numbers as quickly as possible, with total time recorded. Shorter completion times reflect better cognitive performance.

    Measured: Before and inmediately after the intervention

  13. Montreal Cognitive Assessment (MoCA)

    The MoCA is a comprehensive screening tool for mild cognitive impairment, evaluating domains such as executive function, memory, attention, visuospatial ability, and orientation. The score ranges from 0 to 30. Higher scores reflect better overall cognitive function.

    Measured: Before and inmediately after the intervention

  14. Physical Resilience Instrument for Older Adults (PRIFOR)

    The Physical Resilience Instrument for Older Adults (PRIFOR) is a validated 16-item questionnaire designed to assess an individual's capacity to recover and adapt following physical stressors such as illness, injury, or functional decline. It evaluates both internal and external resilience factors across four domains: physical strength and energy, emotional and mental coping ability, perceived control and adaptability, and support from social and healthcare systems. Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), producing a total score ranging from 16 to 80. Higher scores reflect greater physical resilience, indicating a stronger ability to maintain or regain function in the face of health challenges.

    Measured: Before and inmediately after the intervention

  15. Timed Up and Go with Manual Task (TUG-M)

    The TUG-M is a dual-task version of the standard TUG in which participants are asked to perform the same sequence while carrying a cup of water with one hand. This variant assesses functional mobility under motor interference and challenges postural control and attention. Time to complete the task is recorded in seconds. Lower times reflect better motor coordination and dual-task performance, indicating greater safety during daily life activities.

    Measured: Before and inmediately after the intervention

  16. Timed Up and Go with Cognitive Task (TUG-C)

    The TUG-C assesses functional mobility under cognitive load. Participants complete the standard TUG task while simultaneously performing a cognitive task, such as counting backwards or solving a simple mental calculation (e.g., subtracting by threes). This version evaluates the impact of divided attention on mobility and fall risk. Faster times suggest better cognitive-motor integration and executive function.

    Measured: Before and inmediately after the intervention

  17. Cornell Scale for Depression un Dementia (CSDD)

    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.

    Measured: Before and inmediately after the intervention

  18. 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.

    Measured: Before and inmediately after the intervention

  19. 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.

    Measured: Before and inmediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start4 Sep 2025
  3. Primary completion19 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07133568
Sponsor's protocol ID
UNIVERSITY CARDENAL HERRERA-77
Acronym
FEXO-COM
Status last verified
Apr 2026
First submitted
25 Jul 2025
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Azanon-Nogueira P, Garcia-Lucas C, Salvador-Huerta C, Amer-Cuenca JJ, Picher Martinez M, Garcia-Zamora M, Lison JF, Benavent-Caballer V. Fun Exercise for Older Adults (FEXO): study protocol for a randomised controlled trial on intrinsic capacity, adherence and motivation. BMJ Open. 2026 May 27;16(5):e115440. doi: 10.1136/bmjopen-2025-115440.

    PubMed 42203285

Questions about this trial

What is this clinical trial studying?

A study testing Fun Exercise for Older Adults (FEXO) and OTAGO in people with Sarcopenia and Frailty Syndrome, run by Cardenal Herrera University at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrinsic Capacity (time frame: Before and inmediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07133568, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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