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

4. května 2026 aktualizováno: Noelia González-Gálvez, Universidad Católica San Antonio de Murcia

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.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

31

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Španělsko
    • Murcia
      • Murcia, Murcia, Španělsko, 30107
        • UCAM

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Experimental: Traditional training
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.
Behaviorální: Traditional physical conditioning

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.
Experimentální: Experimental: Sport-based skills
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.
Behaviorální: Sport-based individual skills

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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Time Up and Go from baseline at week 8
Časové okno: 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.
Two times. Baseline and 8 weeks later.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Sit and Reach from baseline at week 8
Časové okno: 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
Two times. Baseline and 8 weeks later
Changes in Hand Grip from baseline at week 8
Časové okno: 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.
Two times. Baseline and 8 weeks later
Changes in Sit-ups in 30 seconds from baseline at week 8
Časové okno: 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
Two times. Baseline and 8 weeks later
Changes in 6-minute walk from baseline at week 8
Časové okno: 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
Two times. Baseline and 8 weeks later
Changes in 10 squats from baseline at week 8
Časové okno: Two times. Baseline and 8 weeks later
Participants perform 10 squats as quickly as possible with their hands crossed at chest level
Two times. Baseline and 8 weeks later
Changes in CMJ from baseline at week 8
Časové okno: 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
Two times. Baseline and 12 weeks later
Changes in Blood Pressure from baseline at week 8.
Časové okno: 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
Two times. Baseline and 8 weeks later
Changes in Height from baseline at week 12.
Časové okno: Two times. Baseline and 8 weeks later
Height will be measured using the SECA 217 stadiometer. The subject stands with their feet together
Two times. Baseline and 8 weeks later
Changes in Waist circumference from baseline at week 8
Časové okno: 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.
Two times. Baseline and 8 weeks later
Changes in Body Fat Percentage from baseline at week 8
Časové okno: 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
Two times. Baseline and 8 weeks later
Changes in weight from baseline at 8 weeks.
Časové okno: 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.
Two times. Baseline and 8 weeks later
Changes in Body Mass Index from baseline at week 8
Časové okno: Two times. Baseline and 8 weeks late
BMI will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Two times. Baseline and 8 weeks late
Changes in hydration from baseline at one week 8
Časové okno: Two times. Baseline and 8 weeks later
Hydration will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Two times. Baseline and 8 weeks later
Changes in Skeletal Muscle Mass from baseline at week 8
Časové okno: Two times. Baseline and 8 weeks later
Skeletal Muscle Mass shall be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Two times. Baseline and 8 weeks later
Change in bone mass from baseline at week 8
Časové okno: Two times. Baseline and 8 weeks later
Bone mass will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Two times. Baseline and 8 weeks later
Changes in Visceral Fat from baseline at week 8
Časové okno: Two times. Baseline and 8 weeks later
Visceral Fat will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Two times. Baseline and 8 weeks later

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Universidad Católica San Antonio de Murcia

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. května 2026

Primární dokončení (Odhadovaný)

26. června 2026

Dokončení studie (Odhadovaný)

26. června 2026

Termíny zápisu do studia

První předloženo

4. května 2026

První předloženo, které splnilo kritéria kontroly kvality

4. května 2026

První zveřejněno (Aktuální)

8. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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