Resistance Training Program, Labor Inclusion, Intellectual Disability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Glaucy Davim Raulino, University of Brasilia
ClinicalTrials.gov Identifier:
NCT01456910
First received: October 14, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

Resistance exercise (RE) has been proposed as a possible strategy for prevention and rehabilitation of diseases. The increase in both muscle strength and the ability to perform tasks of day-to-day work environment and are well-characterized benefits of this type of training. The literature has been investigating the effectiveness of the RE for humans, yet few studies have been conducted with intellectual disabilities (ID). It is known that a sedentary lifestyle contributes to the development of cardiovascular disease, type 2 diabetes, hypertension, arthritis, and stress, depression, difficulty in socializing, stigma and discrimination. In particular, the ID is less active and is more likely to develop secondary diseases.


Condition Intervention
Mental Retardation
Body Composition, Beneficial
Muscle Weakness
Behavioral: Resistance Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Evaluation and Effects of a Resistance Training Program and Its Relationship With the Labor Inclusion of the Disabled Intellectual

Resource links provided by NLM:


Further study details as provided by University of Brasilia:

Enrollment: 40
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Working group
G1 intervention group of 20 participants aged 14-36 years old and mild to severe intellectual disability of both gender.
Behavioral: Resistance Training Program
Frequency, volume, repetitions, load, interval
Other Names:
  • Biodex-System3Pro® dynamometer
  • Activities of Daily Living adapted to work productivity
  • InBody 720
Active Comparator: Daily Living
G2 control group continue usual routine
Behavioral: Resistance Training Program
Frequency, volume, repetitions, load, interval
Other Names:
  • Biodex-System3Pro® dynamometer
  • Activities of Daily Living adapted to work productivity
  • InBody 720

Detailed Description:

This study aimed to correlate peak torque with work task performance (WTP) after application of resistance training program (RTP), consisting of 40 sessions, twice a week lasting 90 minutes each session. The sample was constituted by 40 individuals, which were selected from a survey of the records filed at Parents and Friends of Exceptional Children of Federal District/Brazil Association (APAE/DF), taking into consideration the following criteria: be inserted in the Professional Education and Labor Program (PELP) of APAE/DF, age between 14 and 36 years for being the most active labor, show no physical disabilities, do not have cardiac problems, who wish to inform the study and voluntarily sign the Free and Informed Term of Consent with their tutors. Although the participants are residents of various cities in the Federal District, it was not possible to avoid selection bias, since the sample was selected from a single institution, limiting, thus, generalization of results.

After performing the pre-testing peak torque, by Biodex System3Pro Dynamometer, and WTP through 800m, climbing stairs and labor skill (to decorate two tables for 4 people, separated by one meter, for lunch with 2 tablecloths, 8 plates, 8 forks, 8 knives and 8 glasses), participants were randomly assigned to experimental groups - G1 (20 participants) and control - G2 (20 participants), and matched according to age, sex and per capita income, in order to form groups with similar characteristics. The G1 group participated in the RTP in number of eight, four for the upper limbs and four for the lower limbs. In order to avoid confounding bias, participants in the G2 group, along with their tutors, were instructed to continue with their daily activities normally and did not participate in RTP, as well as the G1 also instructed not to participate in other physical activities.

The first Monthly cycle (two weeks) was developed in order to familiarize participants with the equipment and learn how to perform the exercises, avoiding, thus, evaluation bias. Subsequently, we applied the test of one maximum repetition - 1MR, to elaborate a spreadsheet on individual training with the participants. The second, third and fourth Monthly cycles were developed according to the spreadsheet elaborated timeline and orientation of the instructors, which were duly informed. After four months of intervention, all 40 participants were reassessed.

This study was approved by the Ethics and Research Committee at the University of Brasilia under the resolution 196/96 of the National Health Ministry of Health with the record 21/09 and is registered in the National Information System on Ethics in Research Involving Human Subjects - SISNEP with the number of Certificate of Presentation for Ethics Appreciation - CAAE: 0018.0.012.000-09.

The Institutions Association of Parents and Friends of Exceptional Children of Federal District, Resistance Exercise Laboratory of the Faculty of Physical Education at the University of Brasilia, Physics Resistance Gym and Nutriment - Center of Medicine Nutrition were contacted and informed about the research procedures by requesting formal practice of testing due to the participants in this study by signing the Declaration of Institutional Science.

  Eligibility

Ages Eligible for Study:   14 Years to 36 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be intellectually disabled
  2. Be aged between 16 and 36 years
  3. Understand the information provided by the researcher during data collection with the isokinetic dynamometer
  4. Understand the information provided by the researcher during the course of the program of resistance exercise
  5. Do not report pain in the joint tested
  6. Do not have limitations in range of motion of the knee joint
  7. Do not be swollen in the joint
  8. Interest in participating in the study
  9. Sign the Statement of Consent or your parent.

Exclusion Criteria:

  1. Provide cognitive impairment such that he does not understand the instructions necessary to collect data regarding the strength of knee flexion-extension with the isokinetic dynamometer
  2. Cognitive impairment such that he does not understand the instructions needed to perform the necessary movements of resistance exercise program
  3. Display heart
  4. Report pain before the test
  5. Present joint swelling
  6. Use a pacemaker or other electromedical equipment
  7. Failure to properly hold the electrodes
  8. Do not have an interest in participating in the study;
  9. Not having signed an informed consent or your parent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456910

Locations
Brazil
Association of Parents and Friends of Exceptional Children of Federal District/Brazil; Resistance Exercise Laboratory of the Faculty of Physical Education at the UnB/Brazil; Physics Resistance Gym and Nutrimed Clinics - Center of Medicine Nutrition
Brasília, Distrito Federal, Brazil, 70910 900
University of Brasília
Brasília, Distrito Federal, Brazil, 70910 900
Sponsors and Collaborators
University of Brasilia
Investigators
Principal Investigator: Andrea GD Raulino, MD University of Brasilia
  More Information

Additional Information:
No publications provided

Responsible Party: Andrea Glaucy Davim Raulino, Principal Investigator, University of Brasilia
ClinicalTrials.gov Identifier: NCT01456910     History of Changes
Other Study ID Numbers: 0018.0.012.000-09
Study First Received: October 14, 2011
Last Updated: October 24, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Brasilia:
Physical education
People with mental disabilities
muscular strength dynamometer
Performance Evaluation
Occupational health

Additional relevant MeSH terms:
Asthenia
Mental Retardation
Muscle Weakness
Paresis
Signs and Symptoms
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014