NCT07576933

Brief Summary

Intellectual Disability (ID) is characterized by limitations in cognitive functioning and adaptive behavior, often leading to a sedentary lifestyle and lower quality of life. The main objective of this study is to compare the efficacy of two different 8-week training programs on physical fitness and quality of life in adults with ID. The work methodology consists of a randomized controlled trial with two intervention groups: Experimental Group 1 (EG1): Traditional conditioning including strength and resistance exercises (medicine ball, rowing, and coordination circuits). Experimental Group 2 (EG2): Sport-based individual skills program (Special Olympics model) covering soccer, basketball, athletics, and other sports with a playful approach. The sample will be composed of sedentary adults with a clinical diagnosis of ID. The variables studied pre- and post-intervention include body composition, physical fitness (agility, strength, and cardiorespiratory capacity), blood pressure, and quality of life using the INICO-FEAPS scale.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress14%
May 2026Jun 2026

Study Start

First participant enrolled

May 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2026

Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

intellectual disabilitysport-based programtraditional trainingphysical conditionquality of life

Outcome Measures

Primary Outcomes (1)

  • Changes in Time Up and Go from baseline at week 8

    The subject must stand up from a chair, walk to a mark 3 meters away, and return to the starting position while sitting down as quickly as possible; they will have two attempts.

    Two times. Baseline and 8 weeks later.

Secondary Outcomes (16)

  • Changes in Sit and Reach from baseline at week 8

    Two times. Baseline and 8 weeks later

  • Changes in Hand Grip from baseline at week 8

    Two times. Baseline and 8 weeks later

  • Changes in Sit-ups in 30 seconds from baseline at week 8

    Two times. Baseline and 8 weeks later

  • Changes in 6-minute walk from baseline at week 8

    Two times. Baseline and 8 weeks later

  • Changes in 10 squats from baseline at week 8

    Two times. Baseline and 8 weeks later

  • +11 more secondary outcomes

Study Arms (2)

Experimental: Traditional training

EXPERIMENTAL

The traditional fitness program will consist of a structured exercise regimen. This experimental group will participate in two intervention sessions per week, each lasting 60 minutes. The sessions are structured as follows: a 5-minute warm-up, including joint mobility exercises; 45 minutes for the main training phase, focused on strength and endurance through specific exercises (medicine ball squats, thrusters, seated band rows, bench presses, and load carries) and a coordination circuit; and, finally, a 5-minute cool-down. The intensity will be moderate, monitored by the researchers, starting with low loads and increasing the duration of the exercise linearly from 60 to 90 seconds over the course of the 8 weeks.

Behavioral: Traditional physical conditioning

Experimental: Sport-based skills

EXPERIMENTAL

The sport-based skills program will apply a session structure based on the Special Olympics individual skills model. This experimental group will perform 2 intervention sessions per week with a duration of 60 minutes each. The sessions follow a sports-specific block structure (soccer, basketball, floorball, athletics, and boccia) with 3 sessions per sport. Each session includes: 5 to 10 minutes of a preparatory warm-up game related to the specific sport; 45 minutes for the main phase focusing on technical skills progression (aiming, dribbling, shooting, and coordination) through a playful and challenge-based approach; the final minutes of each block will include real-game situations. The duration of the program will be 8 weeks.

Behavioral: Sport-based individual skills

Interventions

The traditional multi-component training group will perform 60 minutes of training per session, 2 days a week for 8 weeks. The program includes: A 5-minute warm-up, which includes joint mobility exercises led by the instructor. A 45-minute main phase, which includes targeted endurance and strength training using a circuit-based approach. Exercises include medicine ball squats, medicine ball thrusters, seated resistance band rows, and chest presses. The circuit is completed once, and the duration of each exercise will increase linearly, starting with 60 seconds per station in week 1 and progressing to 90 seconds in week 8, with a fixed 1-minute rest between exercises. A 5-minute cool-down session that includes relaxation exercises.

Experimental: Traditional training

The sports skills group will conduct 60-minute training sessions twice a week for 8 weeks, following the Special Olympics Individual Skills model. The sessions follow the same structure. A 5- to 10-minute warm-up consisting of a fun, sport-related game designed to increase heart rate and motivation. The main part lasts 45 minutes, during which different skills for each sport are practiced, such as shooting, passing, dribbling, and coordination. The sports covered are soccer, basketball, floorball, track and field, and boccia. There are 3 sessions per sport, following a progression of skill difficulty. The exercises have a playful approach, structured as challenges and competitions. At the end of each sport, a few minutes of real-game situations will be included among all participants. The 5-minute cool-down includes a low-intensity activity and group reflection on the session.

Experimental: Sport-based skills

Eligibility Criteria

Age19 Years - 37 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have a clinically diagnosed intellectual disability
  • Have not engaged in 150 minutes of physical activity per week over the past six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCAM

Murcia, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 26, 2026

Study Completion (Estimated)

June 26, 2026

Last Updated

May 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations