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NCT Number: NCT07576933

Effects of Two Intervention Programs on Physical Fitness and Quality of Life Among People With Intellectual Disabilities

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.

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Key information

Conditions

Intellectual Disabilities Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–37 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM

Murcia, 30107, Spain

About this study

Intellectual Disability (ID) is characterized by limitations in intellectual functioning and adaptive behavior, affecting conceptual, social, and practical skills. Beyond Intelligence Quotient (IQ), ID impact depends on various factors of functioning and adaptive skills. According to the International Classification of Functioning (ICF), individuals with ID often experience difficulties in communication, self-care, decision-making, and problem-solving, as well as impaired psychomotor functioning and mobility. Consequently, this population often reports lower quality of life and reduced participation in social and recreational activities.

While physical activity is fundamental for cognitive, emotional, and physical well-being, individuals with ID have significantly lower rates of exercise practice, which is linked to increased health problems such as obesity and cardiovascular diseases. The main objective of this study is to analyze and compare the efficacy of two different training programs on physical fitness and quality of life in sedentary adults with ID.

Working Methodology The study is a randomized controlled trial (RCT) conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the Catholic University of Murcia (UCAM). The intervention will last 8 weeks, with 2 sessions per week (16 total sessions), each lasting 60 minutes.

The intervention groups are:

Experimental Group 1 (EG1): Traditional conditioning program based on analytical exercises. Sessions include a 5-minute joint mobility warm-up, a 45-minute main phase with constant exercises (medicine ball squats, thrusters, band rowing, chest press, and coordination circuits), and a 5-minute cool-down. Intensity is moderate and progressed linearly by increasing exercise duration from 60 to 90 seconds.

Experimental Group 2 (EG2): Sport-based individual skills program (Special Olympics model). Sessions include activities from soccer, basketball, floorball, athletics, and boccia. Each sport block (3 sessions each) focuses on technical progression (aiming, dribbling, shooting) with a playful approach and real-game situations.

The assessment and protocols are:

Pre- and post-intervention measurements include:

Physical Fitness (SAMU-DISFIT Battery): Evaluation of agility (Timed Up and Go), flexibility (Sit and Reach), manual strength (handgrip dynamometry), abdominal resistance (30-sec sit-ups), lower limb functionality (10-repetition squat test), and cardiorespiratory capacity (6-Minute Walk Test).

Body Composition: Body Mass Index (BMI) and waist circumference (CC) measured following standard protocols, along with bioimpedance analysis for fat mass and muscle percentage.

Strength and Hemodynamics: Lower limb explosive strength via Vertical Jump (CMJ) using Chronojump, and blood pressure measured after a 5-minute rest.

Quality of Life: Comprehensive assessment using the INICO-FEAPS Scale, evaluating 8 multidimensional domains through self-report.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Traditional physical conditioning

Behavioral

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.

Sport-based individual skills

Behavioral

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.

Primary outcomes

  1. Changes in Time Up and Go from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later.

    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.

Secondary outcomes

  1. Changes in Sit and Reach from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    The subject starts from a seated position with legs straight and feet resting on the box, and must push the measuring rod as far as possible using the fingertips of both hands

  2. Changes in Hand Grip from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    The subject should grip the dynamometer as tightly as possible while standing with their arm extended at their side.

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

    Time frame: Two times. Baseline and 8 weeks later

    The participant must perform as many repetitions as possible in 30 seconds while lying on their back with their knees bent, feet flat on the floor, and hands on their thighs. Each repetition is completed by sliding the hands down the thighs until they reach the kneecaps and then returning to the starting position

  4. Changes in 6-minute walk from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    The subject should walk as far as possible in 6 minutes on a flat surface without breaking into a run

  5. Changes in 10 squats from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    Participants perform 10 squats as quickly as possible with their hands crossed at chest level

  6. Changes in CMJ from baseline at week 8

    Time frame: Two times. Baseline and 12 weeks later

    The subject stands on the Chronojump Boscosystem jump platform with one foot on each side and hands on hips at all times, and jumps straight up as hard as possible with legs extended

  7. Changes in Blood Pressure from baseline at week 8.

    Time frame: Two times. Baseline and 8 weeks later

    Blood pressure (sytolic blood pressure and diastolic blood pressure) shall be assessed using the OMRON, model HEM-7133 blood pressure monitor in millimetres of mercury (mmHg). The subject should sit down 5 minutes before the measurement to relax, without talking, with the back well positioned and without crossing the legs. After the 5 minutes of rest, proceed with the two programmed BP measurements, leaving 2 minutes between the two measurements

  8. Changes in Height from baseline at week 12.

    Time frame: Two times. Baseline and 8 weeks later

    Height will be measured using the SECA 217 stadiometer. The subject stands with their feet together

  9. Changes in Waist circumference from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    Waist circumference will be assessed according to the ISAK protocol, using a tape measure and recorded in centimetres (cm). The subject should stand with feet together, arms crossed over the chest and abdomen relaxed; the measurement will be taken at the narrowest point of the waist, between the 10th rib and the iliac crest over the shirt, the subject will be asked to lower the arms to the sides of the body and will be measured at the end of a normal exhalation.

  10. Changes in Body Fat Percentage from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    Body Fat Percentage will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan composition analyser

  11. Changes in weight from baseline at 8 weeks.

    Time frame: Two times. Baseline and 8 weeks later

    Weight will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan. For the assessment, subjects will be informed that they must not wear metal items in contact with the skin such as rings, bracelets or watches.

  12. Changes in Body Mass Index from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks late

    BMI will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan

  13. Changes in hydration from baseline at one week 8

    Time frame: Two times. Baseline and 8 weeks later

    Hydration will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan

  14. Changes in Skeletal Muscle Mass from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    Skeletal Muscle Mass shall be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan

  15. Change in bone mass from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    Bone mass will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan

  16. Changes in Visceral Fat from baseline at week 8

    Time frame: Two times. Baseline and 8 weeks later

    Visceral Fat will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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