- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06180304
Examine the Effects of 24-week Exercise Program on Functional Capacity, Cognitive Capacity, and Quality of Life in Individuals With Intellectual and Developmental Disabilities
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Coimbra, Portugal, 3040-248
- Miguel Jacinto
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Indoor training group
Exercise group in a gym.
|
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).
|
Experimental: outdoor training group
Exercise group in an outdoor space.
|
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).
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No Intervention: Control group
No exercise group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
week 0 and 24
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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).
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week 0 and 24
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Changes in Functional Capacity
Time Frame: week 0, 12 and 24
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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). |
week 0, 12 and 24
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FitnessParaAMente
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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