Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03092167
Other study ID # MYO-HCFMUSP-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date April 29, 2021

Study information

Verified date April 2021
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present study will assess the role of an exercise training program in patients with idiopathic inflammatory myopathies.


Description:

To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 29, 2021
Est. primary completion date April 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of DM / PM according to the criteria of Bohan and Peter (1975) - Both genders and age = 18 years - Use of prednisone = 0.5 mg/kg/day in the last three months. The dose of prednisone will be kept fixed throughout the study - Physically inactive Exclusion Criteria: - Disease relapsing - Neoplasia associated-myositis - Overlapping myositis - Use of lipid-lowering drugs - Smoking - Diabetes mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical exercises
Physical exercises

Locations

Country Name City State
Brazil Samuel Katsuyuki Shinjo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiopulmonary test Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion. VO2peak will be considered as the average of the final 30 s of the test. Ventilatory threshold (VAT) will be determined when ventilatory equivalent for VO2 (VE/VO2) increased without a concomitant increase in ventilatory equivalent for carbon dioxide (VE/VCO2). Respiratory compensation point (RCP) will be determined when VE/VO2 and VE/VCO2 increased simultaneously. 12 weeks
Secondary Serum cytokines Blood samples will be centrifuged at 3000 rpm for 15 min at 4°C, and the serum aliquot will be stored at -80°C for subsequent analyses. Cytokines (i.e., IL-6, TNF alpha, IFN gamma) will be measured using a multiplex human panel (Milliplex Map, Millipore, Billerica, MA, USA). Data analysis will be performed through Luminex xMAP Technology, according to the manufacturer's instructions. 12 weeks
Secondary Strength muscle tests The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm). 12 weeks
Secondary Muscle biopsies After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study) 12 weeks
Secondary Functional muscle tests Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Muscle function will be evaluated through the TUG and the TST tests. 12 weeks
Secondary Myositis Disease Activity Assessment Tool This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. This is a combined tool that includes the Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT), which is a series of physician's assessments of disease activity, and the Myositis Intention to Treat Activity Index (MITAX). 12 weeks
Secondary Muscle enzymes This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase. 12 weeks
Secondary Health Assessment Questionnaire Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00 12 weeks
Secondary Manual Muscle Testing This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. 12 weeks
Secondary Patient/Parent Global Activity This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. 12 weeks
Secondary Physician Global Activity This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale. 12 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Active, not recruiting NCT03903874 - Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt N/A
Recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Withdrawn NCT04540523 - Home-Based Exergaming Intervention N/A
Recruiting NCT03250000 - Changes in Microcirculation and Functional Status During Exacerbation of COPD N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Completed NCT05019482 - Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time N/A
Completed NCT03253406 - Health Wearables and College Student Health N/A
Not yet recruiting NCT05985460 - A Very Brief Intervention to Increase the Intention to Practice Physical Activity N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Completed NCT03380143 - Whole-of-Community Youth Population Physical Activity N/A
Completed NCT03170921 - Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals N/A
Completed NCT04973813 - Active Choice Intervention About Physical Activity for Physically Inactive Adults N/A
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Completed NCT03271112 - Frailty Prevention in Elders From Reunion Island N/A
Completed NCT05670223 - Healthy Activities Improve Lives N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04578067 - Empowering Immigrant Women for Active and Healthy Lifestyle N/A
Completed NCT03297567 - Physical Therapy Guidelines For Hospitalized Elderly N/A