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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04304326
Other study ID # 0928/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date July 30, 2020

Study information

Verified date March 2023
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to assess the effectiveness of Functional training versus resistance training in improving functional capacity, muscle strength, quality of life and disease activity in patients with PSA.


Description:

The Functional Training Group (FT) used elastic bands and the Resistance Exercise Group (RE) used weight training machines. The FT patients performed functional training and RE performed resistance exercises for the following muscles group: upper limbs, lower limbs and trunk. It was used a machine "leg extension" for the training on the lower limbs. For upper limbs the investigators used a pulley triceps machine and front pull in addition to free weights (dumbbells). In order to perform the exercise program, the study followed all the recommendations established by the American College of Sports Medicine (ACSM) (Ratamess et al., 2009). It was carried out two exercises for major muscle groups and one exercise for small muscles. The exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of the exercises was 60% of one-maximum repetition (1RM). The exercise program involved pectoral exercises: crucifix and seat supine; biceps: alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead; quadriceps: leg extensor and finally gluteus: standing hips extension. The patients were instructed to maintain their daily activities and to avoid any other nonpharmacological treatment.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date July 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Confirmed diagnosis of psoriatic arthritis, according to the CASPAR criteria - Between 18 and 65 years of age, of both genders who agreed and signed the consent form. - Patients should be-modifying drugs (DMARDs) on stable doses for at least three months and doses of non-steroidal anti-inflammatory drugs and corticosteroids stable for at least 4 weeks Exclusion Criteria: - Patients were excluded: - Uncontrolled cardiovascular disease - Decompensated diabetes mellitus; diseases - Severe psychiatric - Fibromyalgia - Other medical conditions that most disabling EA - History of regular exercise (at least 30 minutes 2 times per week) during the last 6 months - Arthroplasties of the hip and / or knee in the last 12 months; AND - Any other medical condition that prevents the patient from performing resistance exercises

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Resistence Exercise
Underwent resistance exercise twice a week, for twelve weeks for the following muscles group: upper limbs, lower limbs and trunk. It was carried out two exercises for major muscle groups and one exercise for small muscles. The exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of the exercises was 60% of one-maximum repetition (1RM). The exercise program involved pectoral exercises: crucifix and seat supine; biceps: alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead; quadriceps: leg extensor and finally gluteus: standing hips extension.

Locations

Country Name City State
Brazil São Paulo Hospital Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the functional capacity Evaluated by HAQ-S Health Assessment Questionnaire for the Spondyloarthropathies. There are 20 questions where the score ranges from zero to three. The higher the score, the greater the degree of functional impairment of the patient. Baseline, after 45 and 90 days
Secondary Change in the quality of life Evaluated by the SF-36 questionnaire; The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, where the higher the score the less disability. Baseline, after 45 and 90 days
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