NCT07133568

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

September 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

July 25, 2025

Last Update Submit

April 3, 2026

Conditions

Keywords

intrinsic capacityfun exerciseplayful exercisefrailtymulticomponent exerciseotago

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)

EXPERIMENTAL

Participants 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.

Other: Fun Exercise for Older Adults (FEXO)

OTAGO multicomponent exercise program

ACTIVE COMPARATOR

Participants 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.

Other: OTAGO

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).

FEXO (Fun EXercise for Older adults)
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.

OTAGO multicomponent exercise program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

SarcopeniaFrailty

Interventions

Aging

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological 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 8, 2026

Record last verified: 2026-04

Locations