Effects of Two Intervention Programs on Physical Fitness and Quality of Life Among People With Intellectual Disabilities
1 other identifier
interventional
31
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 4, 2026
CompletedFirst Posted
Study publicly available on registry
May 8, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 26, 2026
May 8, 2026
April 1, 2026
2 months
May 4, 2026
May 4, 2026
Conditions
Keywords
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
EXPERIMENTALThe 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.
Experimental: Sport-based skills
EXPERIMENTALThe 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.
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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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