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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02598739
Other study ID # 0196/11
Secondary ID
Status Completed
Phase N/A
First received August 19, 2014
Last updated November 5, 2015
Start date May 2014
Est. completion date December 2014

Study information

Verified date November 2015
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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


Description:

The IG patients 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 we 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 were 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 gluteo: standing hips extension.

Control Group (CG) The control group was kept in a waiting list while continued with the standard pharmacological treatment during all the study. The patients were instructed to maintain their daily activities and to avoid any other non-pharmacological treatment. The exercise program was offered to the control group in the end of the study.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Resistance exercise
Underwent resistance exercise twice a week, for twelve weeks. The IG patients performed resistance exercises 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 were 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 gluteo: standing hips extension.
Waiting list for the exercises


Locations

Country Name City State
Brazil São Paulo Hospital São Paulo

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 Spondylarthropathies Baseline, after 45 and 90 days No
Secondary Change in the quality of life Evaluated by the SF-36 questionnaire Baseline, after 45 and 90 days No
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