Intellectual DisabilitiesNCT06180304
Examine the Effects of 24-week Exercise Program on Functional Capacity, Cognitive Capacity, and Quality of Life in Individuals With Intellectual and Developmental Disabilities
A study testing Exercise training in people with Intellectual Disabilities, run by Instituto Politécnico de Leiria at 1 site in Portugal.
Trial summary
Physical inactivity and a sedentary lifestyle are prevalent in the population with intellectual and developmental disabilities, and they do not comply with the World Health Organisation's physical activity guidelines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disabilities
- What is being tested?
- Exercise training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 sitePortugal
- Study dates
- 2 May 2023to 16 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Adult institutionalized volunteers from Leiria region (Center Portugal) participated in the exercise intervention program.
Participants were selected using the following inclusion criteria:
- adults with IDD;
- without medical contraindications;
- age over 18 years;
- with mild, moderate or severe IDD diagnosis (Down Syndrome inclusive);
- success in performing movements such as pulling/pushing;
- ability to carry out the intended assessments.
Additionally, we also used the following exclusion criteria:
- individuals who cannot commit for 6 months;
- individuals with other associated pathologies;
- contraindications to PE;
- inability to walk unassisted;
- profound IDD;
- inability to communicate;
- non-delivery of the duly signed informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Physical inactivity and a sedentary lifestyle are prevalent in the population with intellectual and developmental disabilities, and they do not comply with the World Health Organisation's physical activity guidelines. Due to physical inactivity and a sedentary lifestyle, these individuals have low levels of physical fitness (decreasing functional capacity and success in carrying out activities of daily living), with an increased risk of acquiring other comorbidities such as type II diabetes, hypertension, cholesterol and metabolic syndrome, affecting their quality of life.
One of the reasons found in the literature for physical inactivity and sedentary lifestyles in individuals with intellectual and developmental disabilities is the existence of barriers that prevent/difficulty their practice, namely the lack of adapted physical exercise programmes, limited financial resources and lack of venues for their practice. Consequently, there is a dearth of research, including little clarity on the intervention protocols used and a variety of methodologies that address the applicability of non-pharmacological, psychological and psychosocial interventions, such as physical exercise programmes, for the promotion of various variables.
Read more
One of the most studied relationships is between exercise and the promotion of physical fitness, confirming its direct impact on functional capacity. Bearing in mind that studies on cognitive decline only assess some variables that may be associated but do not represent it on their own, such as attention, memory and language fluency. With regard to quality of life, an 8-week multidisciplinary exercise intervention programme aimed to improve quality of life, professional and peer support for activity, abdominal strength and metabolic equivalent gait of the tasks, however, the physical exercise programme is unclear and multimodal. On the other hand, a previous systematic review associated the effects of physical exercise with variables related to quality of life, namely pain, general health and anxiety. In studies focusing on physical activity, these variables have been shown to be predictors of quality of life, however, studies with physical exercise programmes are still cautious or unclear.
Thus, alternative and innovative solutions to promote/maintain physical function, reduce the risk of onset of cognitive decline in early life and promote/maintain the quality of life of individuals with Intellectual and Developmental Difficulty should include physical exercise. Taking this introductory approach into account, this non-randomised experimental study aimed to analyse the effects of two 24-week physical exercise programmes (indoor and outdoor) on functional capacity, cognitive decline and quality of life in institutionalised individuals with intellectual and developmental disabilities.
- Conditions
- Intellectual Disabilities
- Being tested
- Exercise training
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
The indoor physical exercise program was carried out in a gym with weight machines. The physical exercise program was divided into four parts. Part I: playful game or shuttle run (5 to 7 minutes). Part II: aerobic training (treadmill; 10 minutes; 40% to 80% of Heart Rate Reserve; between 12 to 17 according to the Borg Rating Of Perceived Exertion Scale; between 5 to 8 according to the Borg Category-Ratio 10 Scale. Part III: strength training (more or less 25 minutes; Leg Press + Chest Press + Leg Extension + Lat Pull Down + Leg Curl + Shoulder Press; 40-80% of 3 maximum repetitions; 10-15 reps; 2-3 sets). Part IV: 4 static stretches (30 to 60 seconds each).
| Study group | Role | What they receive |
|---|---|---|
| Indoor training group | Experimental | Exercise group in a gym. Receives: Other: Exercise training |
| outdoor training group | Experimental | Exercise group in an outdoor space. Receives: Other: Exercise training |
| Control group | No intervention | No exercise group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Quality of Life
The Portuguese version of the Personal Outcomes Scale was used. The instrument was applied by technicians with specific training aiming to evaluate QoL in people with IDD. The Personal Outcomes Scale includes eight domains, each containing five questions, making a total of forty questions, presented with three response options, through the Likert format, and a higher score (points) indicates better QoL (e.g., 3 = always; 2 = sometimes; 1 = seldom or never). For self-report measure, all composite reliability coefficients were within standards for acceptable internal consistency ranging from 0.75 to 0.91.
Measured: week 0 and 24
Changes in Cognitive function
The Mini-Mental State Examination (MMSE) is a simple paper and pencil test with an easy and quick application (about 5 to 10 minutes) aiming to screen cognitive decline. MMSE test was adapted to the Portuguese population by Guerreiro et al. (1994) and used with IDD population. The thirty items questionnaire (scored 0 value - when the person gives an incorrect answer or simply does not answer or scored 1value - when the person answers correctly), is organized in six domains: Orientation, Retention, Attention and Calculation, Evocation, Language. The maximum test score is thirty points, with higher scores indicating better results. Its score ranges from 0 to 30 points, and the cut-off values that classify individuals into cognitive profiles are: a) severe cognitive impairment (1-9 pts); b) moderate cognitive impairment (10-18 pts) mild cognitive impairment (19-24 pts), d) normal cognitive status (25 pts and above).
Measured: week 0 and 24
Changes in Functional Capacity
Fullerton battery of functional tests was used to assess physical fitness, namely:
- the "sit to stand" for 30 seconds test, validated for the IDD population evaluated the strength and resistance of the lower limbs. The purpose of the test is to assess the strength and the resistance of the lower limbs (number of executions in 30 seconds without using the upper limbs - repetitions). The test begins with the participant sitting in the middle of the chair, with the back straight and feet shoulder-width apart and fully supported on the floor; ii) the "Timed up and Go" test, validated for the IDD population aimed to assess physical mobility, namely speed, agility and dynamic balance (seconds); iii) the "6-minute walk" test validated for IDD population aimed to assess aerobic resistance by covering the greatest distance in 6 minutes (minutes).
Measured: week 0, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start2 May 2023
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180304
- Sponsor's protocol ID
- FitnessParaAMente
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examine the Effects of 24-week Exercise Program on Functional Capacity, Cognitive Capacity, and Quality of Life in Individuals With Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT06180304
- Acronym / sponsor ID
- FitnessParaAMente
- Conditions
- Intellectual Disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 22 Dec 2023 (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.
Physical inactivity and a sedentary lifestyle are prevalent in the population with intellectual and developmental disabilities, and they do not comply with the World Health Organisation's physical activity guidelines. Due to physical inactivity and a sedentary lifestyle, these individuals have low levels of physical fitness (decreasing functional capacity and success in carrying out activities of daily living), with an increased risk of acquiring other comorbidities such as type II diabetes, hypertension, cholesterol and metabolic syndrome, affecting their quality of life.
One of the reasons found in the literature for physical inactivity and sedentary lifestyles in individuals with intellectual and developmental disabilities is the existence of barriers that prevent/difficulty their practice, namely the lack of adapted physical exercise programmes, limited financial resources and lack of venues for their practice. Consequently, there is a dearth of research, including little clarity on the intervention protocols used and a variety of methodologies that address the applicability of non-pharmacological, psychological and psychosocial interventions, such as physical exercise programmes, for the promotion of various variables.
One of the most studied relationships is between exercise and the promotion of physical fitness, confirming its direct impact on functional capacity. Bearing in mind that studies on cognitive decline only assess some variables that may be associated but do not represent it on their own, such as attention, memory and language fluency. With regard to quality of life, an 8-week multidisciplinary exercise intervention programme aimed to improve quality of life, professional and peer support for activity, abdominal strength and metabolic equivalent gait of the tasks, however, the physical exercise programme is unclear and multimodal. On the other hand, a previous systematic review associated the effects of physical exercise with variables related to quality of life, namely pain, general health and anxiety. In studies focusing on physical activity, these variables have been shown to be predictors of quality of life, however, studies with physical exercise programmes are still cautious or unclear.
Thus, alternative and innovative solutions to promote/maintain physical function, reduce the risk of onset of cognitive decline in early life and promote/maintain the quality of life of individuals with Intellectual and Developmental Difficulty should include physical exercise. Taking this introductory approach into account, this non-randomised experimental study aimed to analyse the effects of two 24-week physical exercise programmes (indoor and outdoor) on functional capacity, cognitive decline and quality of life in institutionalised individuals with intellectual and developmental disabilities.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indoor training group | Experimental | Other: Exercise trainingExercise group in a gym. |
| outdoor training group | Experimental | Other: Exercise trainingExercise group in an outdoor space. |
| Control group | No intervention | –No exercise group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Exercise trainingThe indoor physical exercise program was carried out in a gym with weight machines. The physical exercise program was divided into four parts. Part I: playful game or shuttle run (5 to 7 minutes). Part II: aerobic training (treadmill; 10 minutes; 40% to 80% of Heart Rate Reserve; between 12 to 17 according to the Borg Rating Of Perceived Exertion Scale; between 5 to 8 according to the Borg Category-Ratio 10 Scale. Part III: strength training (more or less 25 minutes; Leg Press + Chest Press + Leg Extension + Lat Pull Down + Leg Curl + Shoulder Press; 40-80% of 3 maximum repetitions; 10-15 reps; 2-3 sets). Part IV: 4 static stretches (30 to 60 seconds each). | Other | Indoor training group, outdoor training group |
Primary outcome
Changes in Quality of Life
Time frame: week 0 and 24
The Portuguese version of the Personal Outcomes Scale was used. The instrument was applied by technicians with specific training aiming to evaluate QoL in people with IDD. The Personal Outcomes Scale includes eight domains, each containing five questions, making a total of forty questions, presented with three response options, through the Likert format, and a higher score (points) indicates better QoL (e.g., 3 = always; 2 = sometimes; 1 = seldom or never). For self-report measure, all composite reliability coefficients were within standards for acceptable internal consistency ranging from 0.75 to 0.91.
Changes in Cognitive function
Time frame: week 0 and 24
The Mini-Mental State Examination (MMSE) is a simple paper and pencil test with an easy and quick application (about 5 to 10 minutes) aiming to screen cognitive decline. MMSE test was adapted to the Portuguese population by Guerreiro et al. (1994) and used with IDD population. The thirty items questionnaire (scored 0 value - when the person gives an incorrect answer or simply does not answer or scored 1value - when the person answers correctly), is organized in six domains: Orientation, Retention, Attention and Calculation, Evocation, Language. The maximum test score is thirty points, with higher scores indicating better results. Its score ranges from 0 to 30 points, and the cut-off values that classify individuals into cognitive profiles are: a) severe cognitive impairment (1-9 pts); b) moderate cognitive impairment (10-18 pts) mild cognitive impairment (19-24 pts), d) normal cognitive status (25 pts and above).
Changes in Functional Capacity
Time frame: week 0, 12 and 24
Fullerton battery of functional tests was used to assess physical fitness, namely: i) the "sit to stand" for 30 seconds test, validated for the IDD population evaluated the strength and resistance of the lower limbs. The purpose of the test is to assess the strength and the resistance of the lower limbs (number of executions in 30 seconds without using the upper limbs - repetitions). The test begins with the participant sitting in the middle of the chair, with the back straight and feet shoulder-width apart and fully supported on the floor; ii) the "Timed up and Go" test, validated for the IDD population aimed to assess physical mobility, namely speed, agility and dynamic balance (seconds); iii) the "6-minute walk" test validated for IDD population aimed to assess aerobic resistance by covering the greatest distance in 6 minutes (minutes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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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. This study is not recruiting at the moment.
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 Exercise training in people with Intellectual Disabilities, run by Instituto Politécnico de Leiria at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 22 Dec 2023. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Quality of Life (time frame: week 0 and 24). The study lists 3 primary outcomes in all. 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 22 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.