Intellectual DisabilitiesNCT07576933
Effects of Two Intervention Programs on Physical Fitness and Quality of Life Among People With Intellectual Disabilities
A study testing Traditional physical conditioning and Sport-based individual skills in people with Intellectual Disabilities, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 37 years
- Conditions the study is for
- Intellectual Disabilities
- What is being tested?
- Traditional physical conditioning and Sport-based individual skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2026to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 37 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a clinically diagnosed intellectual disability
- Have not engaged in 150 minutes of physical activity per week over the past six months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Intellectual Disabilities
- Being tested
- Traditional physical conditioning, Sport-based individual skills
- Keywords
- intellectual disability, sport-based program, traditional training, physical condition, quality of life
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional physical conditioningBehavioural
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 skillsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sport-based individual skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two times. Baseline and 8 weeks later.
Secondary outcomes (16)
Changes in Sit and Reach from baseline at week 8
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
Measured: Two times. Baseline and 8 weeks later
Changes in Hand Grip from baseline at week 8
The subject should grip the dynamometer as tightly as possible while standing with their arm extended at their side.
Measured: Two times. Baseline and 8 weeks later
Changes in Sit-ups in 30 seconds from baseline at week 8
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
Measured: Two times. Baseline and 8 weeks later
Changes in 6-minute walk from baseline at week 8
The subject should walk as far as possible in 6 minutes on a flat surface without breaking into a run
Measured: Two times. Baseline and 8 weeks later
Changes in 10 squats from baseline at week 8
Participants perform 10 squats as quickly as possible with their hands crossed at chest level
Measured: Two times. Baseline and 8 weeks later
Changes in CMJ from baseline at week 8
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
Measured: Two times. Baseline and 12 weeks later
Changes in Blood Pressure from baseline at week 8.
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
Measured: Two times. Baseline and 8 weeks later
Changes in Height from baseline at week 12.
Height will be measured using the SECA 217 stadiometer. The subject stands with their feet together
Measured: Two times. Baseline and 8 weeks later
Changes in Waist circumference from baseline at week 8
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.
Measured: Two times. Baseline and 8 weeks later
Changes in Body Fat Percentage from baseline at week 8
Body Fat Percentage will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan composition analyser
Measured: Two times. Baseline and 8 weeks later
Changes in weight from baseline at 8 weeks.
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.
Measured: Two times. Baseline and 8 weeks later
Changes in Body Mass Index from baseline at week 8
BMI will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Measured: Two times. Baseline and 8 weeks late
Changes in hydration from baseline at one week 8
Hydration will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Measured: Two times. Baseline and 8 weeks later
Changes in Skeletal Muscle Mass from baseline at week 8
Skeletal Muscle Mass shall be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Measured: Two times. Baseline and 8 weeks later
Change in bone mass from baseline at week 8
Bone mass will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Measured: Two times. Baseline and 8 weeks later
Changes in Visceral Fat from baseline at week 8
Visceral Fat will be assessed by bioimpedance with the TANITA BF-522 W, Tokyo, Japan
Measured: Two times. Baseline and 8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 May 2026 (estimated)
- Primary completion26 Jun 2026 (estimated)
- Study completion26 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia González-Gálvez, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576933
- Sponsor's protocol ID
- UCMurcia-
- Status last verified
- Apr 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Intervention Programs on Physical Fitness and Quality of Life Among People With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT07576933
- Acronym / sponsor ID
- UCMurcia-
- Conditions
- Intellectual Disabilities
- Keywords
- intellectual disability, sport-based program, traditional training, physical condition, quality of life
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 26 Jun 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Traditional training | Experimental | Behavioral: Traditional physical conditioningThe 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 | Experimental | Behavioral: Sport-based individual skillsThe 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. |
Who may qualify
- Ages
- 19 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have a clinically diagnosed intellectual disability
- Have not engaged in 150 minutes of physical activity per week over the past six months
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional physical conditioningThe 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. | Behavioural | Experimental: Traditional training |
| Sport-based individual skillsThe 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. | Behavioural | Experimental: Sport-based skills |
Primary outcome
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.
16 secondary outcomes
Changes in Sit and Reach from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in Hand Grip from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in Sit-ups in 30 seconds from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in 6-minute walk from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in 10 squats from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in CMJ from baseline at week 8
Time frame: Two times. Baseline and 12 weeks later
Changes in Blood Pressure from baseline at week 8.
Time frame: Two times. Baseline and 8 weeks later
Changes in Height from baseline at week 12.
Time frame: Two times. Baseline and 8 weeks later
Changes in Waist circumference from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in Body Fat Percentage from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in weight from baseline at 8 weeks.
Time frame: Two times. Baseline and 8 weeks later
Changes in Body Mass Index from baseline at week 8
Time frame: Two times. Baseline and 8 weeks late
Changes in hydration from baseline at one week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in Skeletal Muscle Mass from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Change in bone mass from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Changes in Visceral Fat from baseline at week 8
Time frame: Two times. Baseline and 8 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional physical conditioning and Sport-based individual skills in people with Intellectual Disabilities, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Time Up and Go from baseline at week 8 (time frame: Two times. Baseline and 8 weeks later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.