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Comparison of the Effectiveness of Functional Training Versus Resistance Exercises in Patients With Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistence Exercise
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psoriatic Arthritis focused on measuring Functional training, Physical exercise, Psoriatic arthritis, Quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • São Paulo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervational

Arms and Interventions

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 9, 2020
Last Updated
March 28, 2023
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04304326
Brief Title
Comparison of the Effectiveness of Functional Training Versus Resistance Exercises in Patients With Psoriatic Arthritis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Functional training, Physical exercise, Psoriatic arthritis, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervational
Arm Type
Experimental
Arm Description
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.
Arm Title
Arms and Interventions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Resistence Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the functional capacity
Description
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.
Time Frame
Baseline, after 45 and 90 days
Secondary Outcome Measure Information:
Title
Change in the quality of life
Description
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.
Time Frame
Baseline, after 45 and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil Natour, PHD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
São Paulo Hospital
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

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Comparison of the Effectiveness of Functional Training Versus Resistance Exercises in Patients With Psoriatic Arthritis

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