Resistance Training Program, Labor Inclusion, Intellectual Disability

Muscle Weakness Clinical Trial

Official title:

Evaluation and Effects of a Resistance Training Program and Its Relationship With the Labor Inclusion of the Disabled Intellectual

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456910
• Other study ID #: 0018.0.012.000-09
• Status: Completed
• Phase: N/A
• First received: October 14, 2011
• Last updated: October 24, 2011
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 36 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Intellectual Disability
• Mental Retardation
• Muscle Weakness
• Paresis

Intervention

Behavioral:
• Resistance Training Program
Frequency, volume, repetitions, load, interval

Locations

Country	Name	City	State
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	University of Brasília	Brasília	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Stopka C, Limper L, Siders R, Graves J, Goodeman A, Silvestone E. Effects of a supervised resistence training program on adolescents and young adults with mental retardation. J Strength Cond Res 1994; 8(3): 184-7. Croce RV, Horvat M. Effects of reinforcem

External Links

•   National information on ethics in research involving human