Clinical trial NCT02761590: Circuit Training on Knee Osteoarthritis Patients
Official title: Influence of a Circuit Trining Protocol on Intermuscular Adipose Tissue of Knee Osteoarthritis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: intermuscular fat
circuit training
adipokines
inflammation
computed tomography scan
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2016-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study presents a randomized controlled trial design. They will be selected 40 participants diagnosed with knee OA grades II and III, aged 40 and 65 years and BMI \<30 kg / m2 were randomly divided into two groups: participants underwent training (trained group - TG) and not subjected to training ( untrained group - NTG). The participants trained group will undergo a periodized CT protocol of 14 weeks load progression, 3 times a week, with sessions last 15 minutes in the first weeks and will arrive 35 minutes in final weeks, and added 10 minutes between heating and cooling down. All subjects will conduct pre and post CT variables: IMAT thigh (computed tomography); body composition (Dual-energy X-ray absorptiometry - DXA), inflammatory biomarker concentrations: IL-1β, IL-6, IL-10, TNF-α, leptin and adiponectin and joint degradation biomarkers (uCTX-II and sCOMP), performance tests functional (six-minute walk, 30 seconds chair stand test and stair climb test), muscle strength (maximum voluntary isometric contraction - MVIC), WOMAC and KOOS questionnaires, and catastrophizing pain scale. During the training protocol, uCTX-II variables, sCOMP and MVIC will also be evaluated. To compare the groups will be applied the unpaired t-test. When found significant main effects, the Bonferroni test will be used to identify the statistically significant differences. To compare the collections times (pre, during and post TC) for uCTX-II variables, sCOMP and MVIC will be held repeated measures ANOVA with post hoc Bonferroni, and the WOMAC variables, KOOS, DXA, IMAT, functional testing and inflammatory cytokines (pre and post CT) will be held the paired t test. A significance level of 5% (p ≤ 0.05) will be adopted.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline Intermuscular adipose tissue (IMAT) at 14 weeks
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
Secondary outcomes:
measure: Body composition
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
measure: Inflammation and degradation of cartilage biomarkers
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
measure: Muscle strength
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
Other outcomes:
measure: WOMAC questionaire
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
measure: KOOS questionaire
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
measure: Catastrophizing Scale of Pain
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
measure: 40 meters fasted paced walk test
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
measure: 30 seconds chair stand test
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
measure: Stair climb test
timeFrame: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Aline C Almeida, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.