search
Back to results

Evaluation of the Effectiveness of Resistance Training in Patients With Psoriatic Arthritis (PSA)

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance exercise
Waiting list for the exercises
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 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

Other

Arm Label

Resistance exercise

Control group

Arm 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 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.

Outcomes

Primary Outcome Measures

Change in the functional capacity
Evaluated by HAQ-S Health Assessment Questionnaire for the Spondylarthropathies

Secondary Outcome Measures

Change in the quality of life
Evaluated by the SF-36 questionnaire

Full Information

First Posted
August 19, 2014
Last Updated
November 5, 2015
Sponsor
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT02598739
Brief Title
Evaluation of the Effectiveness of Resistance Training in Patients With Psoriatic Arthritis
Acronym
PSA
Official Title
Resistance Training in Patients With Psoriatic Arthritis Improves Function, Disease Activity and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
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
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise
Arm Type
Experimental
Arm 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 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.
Arm Title
Control group
Arm Type
Other
Arm Description
Waiting list for the exercises.
Intervention Type
Other
Intervention Name(s)
Resistance exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waiting list for the exercises
Primary Outcome Measure Information:
Title
Change in the functional capacity
Description
Evaluated by HAQ-S Health Assessment Questionnaire for the Spondylarthropathies
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
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
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Effectiveness of Resistance Training in Patients With Psoriatic Arthritis

We'll reach out to this number within 24 hrs