NCT01456910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

October 14, 2011

Last Update Submit

October 24, 2011

Conditions

Keywords

Physical educationPeople with mental disabilitiesmuscular strength dynamometerPerformance EvaluationOccupational health

Study Arms (2)

Working group

EXPERIMENTAL

G1 intervention group of 20 participants aged 14-36 years old and mild to severe intellectual disability of both gender.

Behavioral: Resistance Training Program

Daily Living

ACTIVE COMPARATOR

G2 control group continue usual routine

Behavioral: Resistance Training Program

Interventions

Frequency, volume, repetitions, load, interval

Also known as: Biodex-System3Pro® dynamometer, Activities of Daily Living adapted to work productivity, InBody 720
Daily LivingWorking group

Eligibility Criteria

Age14 Years - 36 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • Cognitive impairment such that he does not understand the instructions needed to perform the necessary movements of resistance exercise program
  • Display heart
  • Report pain before the test
  • Present joint swelling
  • Use a pacemaker or other electromedical equipment
  • Failure to properly hold the electrodes
  • Do not have an interest in participating in the study;
  • Not having signed an informed consent or your parent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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, Federal District, 70910 900, Brazil

Location

University of Brasília

Brasília, Federal District, 70910 900, Brazil

Location

Related 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 reinforcement-based exercise on fitness and work productivity in adults with mental retardation. Adapt Phys Activ Q 1992; 9:148-78. Shields N, Taylor NF, Dodd KJ. Effects of a community-based progressive resistance training program on muscle performance and physical function in adults with Down syndrome: a randomize controlled trail. Arch. Phys. Med. Rehabil 2008; 89: 1215-20. Zetts R, Horvat M, Langone J. Effects of a community-based progressive resistence training program the work productivity of adolescents with moderate to severe intellectual disabilities. Educ Train Ment Retard 1995; 30:166-78. Smail K, Horvat M. Relationship of muscular strength on work performance in high school students with mental retardation. Educ. Train Dev. Disabil. 2006 Dec; 41(4):410-19. Andreotti RA, Okuma SS. Validação de uma bateria de testes de atividades da vida diária para idosos fisicamente independentes. Rev paul educ fís 1999; 13(1):46-66. Carmeli E, Ayalon M, Barchard S, Sheklow SL, Reznik AZ. Isokinetic leg strength of institutionalized older adults with mental retardation with and without Down's syndrome. J Strength Cond Res 2001; 16(2): 316-20. Rimmer JH, Kelly LE. Effects of a resistance training program of adults with mental retardation. Adapt Phys Activ Q 1991; 8:146-53. Mendoca GV, Pereira FD, Fernhall B. Effects of combined aerobic and resistence exercise training in adults with and without Down syndorme. Arch Phys Med Rehabil 2011; 92: 37-45. Shields N, Taylor NF, Fernhall B. A study protocol of randomized controlled trial to investigate if a community based strength training programme improves work task performance in young adults with Down syndrome. BMC Pediatr 2010; 10-17.

    RESULT

Related Links

MeSH Terms

Conditions

Intellectual DisabilityGlucocorticoid Receptor DeficiencyMuscle Weakness

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsPathologic Processes

Study Officials

  • Andrea GD Raulino, MD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 21, 2011

Study Start

June 1, 2009

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

October 25, 2011

Record last verified: 2011-10

Locations