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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02961543
Other study ID # FUHSPortoAlegre_III
Secondary ID
Status Completed
Phase N/A
First received November 9, 2016
Last updated February 7, 2018
Start date July 2016
Est. completion date December 2017

Study information

Verified date February 2018
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized clinical trial involving 30 individuals submitted to ACL reconstruction will be conducted.

Participants will be randomized into: Group I, submitted to a muscular rehabilitation program based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation programs based on eccentric isotonic and isokinetic exercise will begin 45 days after ACL reconstruction. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Young adults aged between 18 and 40 years;

- Recreational athletes;

- Unilateral ACL injury;

- Presence of total or partial rupture of unilateral ACL within 90 days after injury;

- Male subjects;

- Classification of body mass index up to pre-obese (25.0 - 29.9 kg / m2);

- Not undergoing any strength training program for the lower limbs in the six months prior to the study.

- Acceptance of individuals in participating in the procedures proposed by the research.

Exclusion Criteria:

- Recidivism in ligament injuries;

- Associated ligament and / or meniscal lesions;

- Previous history (<6 months) of musculoskeletal lesions in the thigh;

- Patellar tendinopathy;

- Patellofemoral pain syndrome;

- Respiratory or cardiovascular conditions that limit the performance of exercises;

- Users of dietary supplements or anabolic steroids

Study Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries
  • Anterior Cruciate Ligament Injury

Intervention

Other:
Isokinetic eccentric exercises
The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality. 45 days after ACL reconstruction, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isokinetic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.
Isotonic eccentric exercises
The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality. 45 days after ACL reconstruction, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isotonic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.

Locations

Country Name City State
Brazil Universidade Federal de Ciências da Saúde de Porto Alegre Porto Alegre RS

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary The femoral quadriceps muscle mass through nuclear magnetic resonance imaging Change from baseline and six weeks after intervention protocol
Secondary Performance of knee extensors through computerized dynamometry Change from baseline and six weeks after intervention protocol
Secondary Functionality of the individuals through Lysholm score Change from baseline and six weeks after intervention protocol
Secondary Functionality of the individuals through single and triple hop test Change from baseline and six weeks after intervention protocol
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