- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04304326
Comparison of the Effectiveness of Functional Training Versus Resistance Exercises in Patients With Psoriatic Arthritis
Compare the Effectiveness of Functional Training Versus Resistance Exercises in Patients With Psoriatic Arthritis in Improving Functional Capacity, Disease Activity and Quality of Life
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil
- São Paulo Hospital
-
-
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: Intervational
FT: Functional training with elastic band 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 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. |
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. |
|
Experimental: Arms and Interventions
Resistance exercise with weight training machines. 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. |
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. |
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 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 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; 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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jamil Natour, PHD, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0928/2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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