NCT02761590

Brief Summary

Introduction: The increase in intermuscular adipose tissue (IMAT) can contribute to muscle weakness and consequently on progression of knee OA. The prescription of exercise protocols has been used as a treatment strategy to minimize some of the bouts. Circuit training (CT) involves the combination of strength training and aerobic in the same session and has shown benefits in body composition and physical function. But the literature is unclear with respect to the influences of CT in the concentration of IMAT in the population with knee OA. Objective: To investigate the influence of a 14-week CT protocol in body composition and thigh IMAT concentration as well as cartilage degradation indicators and systemic inflammation and its impact on quality of life in patients with knee OA.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3.8 years

First QC Date

April 28, 2016

Last Update Submit

October 9, 2018

Conditions

Knee Osteoarthritis

Keywords

intermuscular fatcircuit trainingadipokinesinflammationcomputed tomography scan

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Intermuscular adipose tissue (IMAT) at 14 weeks

    The concentration of intermuscular fat tissue will be measured by computed tomography. The images will be obtained through a CT scanner Multislice (Brilliance CT 16-slice, Phillips), located at the University Hospital of San Carlos. The examination will be conducted by experienced personnel under the supervision of a radiologist, developer of this study. The suggested protocol will provide an image related to the mid-thigh area of both legs. Quantification of intermuscular fat quadriceps muscle will be carried out by a slice thickness of 10 mm corresponding to half the distance between the greater trochanter and the intercondylar notch of the femur. The analyzes of the areas will be manually performed using the software OsiriX., And the area of interest selected by a scan, in accordance with the density of tissue decay rates for quantification of adipose tissue present in cm2.

    baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training

Secondary Outcomes (3)

  • Body composition

    baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training

  • Inflammation and degradation of cartilage biomarkers

    baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training

  • Muscle strength

    baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training

Other Outcomes (6)

  • WOMAC questionaire

    baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training

  • KOOS questionaire

    baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training

  • Catastrophizing Scale of Pain

    baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training

  • +3 more other outcomes

Study Arms (3)

Circuit training protocol

EXPERIMENTAL

The CT protocol will be held in three sessions per week for 14 weeks. The volume of work is defined by the training section of time and intensity of effort by the heart rate response to exercise. The construction of own model of periodization to be used complies with the biological principle of interdependence volume vs. intensity, and duration of 14 weeks, proposing a week of recuperative exercises after two weeks of stress, gradually increasing the intensity with respective volume settings. This model is based on the concepts described by Turner et al. that concludes in favor of the organization of training adapted to the reality of the public to be trained.

Other: Circuit training protocol

Strength training protocol

ACTIVE COMPARATOR

The strength training protocol was performed in three sessions per week for 14 weeks and divided into three levels. The initial load set for each exercise was based on the one repetition maximum test (1 RM). Strengthening exercises were performed in two sets of 15 repetitions, using 25% 1RM for hip adductors and abductors, and 50% 1RM for the quadriceps and hamstrings, using ankle weights. Exercises for the trunk were performed in 3 10-second series, increasing the duration when participants were able.

Other: Circuit training protocol

Educational Protocol

NO INTERVENTION

In order to provide care, social interaction, and health education, an educational protocol was conducted. This protocol consisted in interactive presentations of 60 minutes, twice a month for 14 weeks, totaling 7 meetings. The topics addressed pathophysiology of osteoarthritis, and American College of Rheumatology (ACR) recommendations on nutrition, posture, and lifestyle.

Interventions

Circuit training protocolOTHER

The construction of own model of periodization to be used complies with the biological principle of interdependence volume vs. intensity, and duration of 14 weeks, proposing a week of recuperative exercises after two weeks of stress, gradually increasing the intensity with respective volume settings. This model is based on the concepts described by Turner et al. which concludes in favor of the organization of training adapted to the reality of the public to be trained.

Circuit training protocolStrength training protocol

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged between 40 and 65
  • sedentary
  • radiographically and clinically diagnosed with knee OA

You may not qualify if:

  • performed physical therapy or exercise protocol up to 6 months prior to the beginning of the evaluations of this study
  • previous knee surgeries
  • previous history of trauma to the lower limb
  • corticosteroid infiltration in knees in the 30 days prior to baseline
  • prosthesis (partial or total) hip or knee arthritis
  • use of chondroprotective
  • cognitive deficits that compromise the understanding of tests and exercises
  • body mass index (BMI) ≥30 kg / m²
  • heart disease uncontrolled
  • history of muscle injuries severe (above grade I)
  • motor deficits due to neuromuscular disease
  • cardiac pacemaker use
  • chronic diseases
  • impaired renal function, or any other medical condition that makes it impossible to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Carlos

São Carlos, São Paulo, 13564-560, Brazil

Location

Related Publications (3)

  • de Almeida AC, Aily JB, Pedroso MG, Goncalves GH, Pastre CM, Mattiello SM. Reductions of cardiovascular and metabolic risk factors after a 14-week periodized training model in patients with knee osteoarthritis: a randomized controlled trial. Clin Rheumatol. 2021 Jan;40(1):303-314. doi: 10.1007/s10067-020-05213-1. Epub 2020 Jun 8.

    PMID: 32514678DERIVED

  • de Almeida AC, Aily JB, Pedroso MG, Goncalves GH, de Carvalho Felinto J, Ferrari RJ, Pastre CM, Mattiello SM. A periodized training attenuates thigh intermuscular fat and improves muscle quality in patients with knee osteoarthritis: results from a randomized controlled trial. Clin Rheumatol. 2020 Apr;39(4):1265-1275. doi: 10.1007/s10067-019-04892-9. Epub 2019 Dec 21.

    PMID: 31865505DERIVED

  • de Almeida AC, Pedroso MG, Aily JB, Goncalves GH, Pastre CM, Mattiello SM. Influence of a periodized circuit training protocol on intermuscular adipose tissue of patients with knee osteoarthritis: protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 Nov 30;19(1):421. doi: 10.1186/s12891-018-2325-y.

    PMID: 30497420DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeInflammation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aline C Almeida, MSc

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 4, 2016

Study Start

March 1, 2015

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

BR(1)