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

2026年5月4日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

31

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Murcia
      • Murcia、Murcia、西班牙、30107
        • UCAM

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

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.

实验性的: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.

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changes in Time Up and Go from baseline at week 8
大体时间: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.

次要结果测量

结果测量
措施说明
大体时间
Changes in Sit and Reach from baseline at week 8
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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.
大体时间: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.
大体时间: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
大体时间: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
大体时间: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.
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2026年6月26日

研究完成 (估计的)

2026年6月26日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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