- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598739
Evaluation of the Effectiveness of Resistance Training in Patients With Psoriatic Arthritis (PSA)
Resistance Training in Patients With Psoriatic Arthritis Improves Function, Disease Activity and Quality of Life
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
São Paulo, Brazil
- São Paulo Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance 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 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. |
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. |
|
Other: Control group
Waiting list for the exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the functional capacity
Time Frame: Baseline, after 45 and 90 days
|
Evaluated by HAQ-S Health Assessment Questionnaire for the Spondylarthropathies
|
Baseline, after 45 and 90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the quality of life
Time Frame: Baseline, after 45 and 90 days
|
Evaluated by the SF-36 questionnaire
|
Baseline, after 45 and 90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jamil Natour, PHD, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0196/11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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