NCT02961530

Brief Summary

A randomized clinical trial involving 32 individuals submitted to partial menisectomy 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 15 days after partial menisectomy. The programs will last six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

November 9, 2016

Last Update Submit

February 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The femoral quadriceps muscle mass through nuclear magnetic resonance imaging

    Change from baseline and six weeks after intervention protocol

Secondary Outcomes (3)

  • Performance of knee extensors through computerized dynamometry

    Change from baseline and six weeks after intervention protocol

  • Functionality of the individuals through Lysholm score

    Change from baseline and six weeks after intervention protocol

  • Functionality of the individuals through single and triple hop test

    Change from baseline and six weeks after intervention protocol

Study Arms (2)

Group 1.

EXPERIMENTAL

The participants randomly allocated to this arm will undergo a muscular rehabilitation program based on the isokinetic eccentric exercise for the extensor muscles of the operated knee. The contralateral non-operated lower limb will be used as control, so it will not undergo any muscular rehabilitation program.

Other: Isokinetic eccentric exercises

Group 2.

ACTIVE COMPARATOR

The participants randomly allocated to this arm will undergo a muscular rehabilitation program based on the isotonic eccentric exercise for the extensor muscles of the operated knee. The contralateral non-operated lower limb will be used as control, so it will not undergo any muscular rehabilitation program.

Other: Isotonic eccentric exercises

Interventions

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. 15 days after partial menisectomy, 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.

Group 1.

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. 15 days after partial menisectomy, 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.

Group 2.

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Young adults aged between 18 and 40 years;
  • Recreational athletes;
  • Unilateral partial meniscal tear;
  • Partial meniscectomy by video-arthroscopy 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.

You may not qualify if:

  • Repeated meniscal tear; Associated ligament injuries; 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

Location

Study Officials

  • Marlon F Vidmar, MSc

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 11, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations