NCT02598739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

August 19, 2014

Last Update Submit

November 5, 2015

Conditions

Psoriatic Arthritis

Keywords

Physical exercisePsoriatic arthritisQuality of life

Outcome Measures

Primary Outcomes (1)

  • Change in the functional capacity

    Evaluated by HAQ-S Health Assessment Questionnaire for the Spondylarthropathies

    Baseline, after 45 and 90 days

Secondary Outcomes (1)

  • Change in the quality of life

    Baseline, after 45 and 90 days

Study Arms (2)

Resistance exercise

EXPERIMENTAL

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.

Other: Resistance exercise

Control group

OTHER

Waiting list for the exercises.

Other: Waiting list for the exercises

Interventions

Resistance exerciseOTHER

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.

Resistance exercise
Waiting list for the exercisesOTHER
Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Paulo Hospital

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Arthritis, PsoriaticMotor Activity

Interventions

Resistance TrainingWaiting Lists

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Jamil Natour, PHD

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2014

First Posted

November 6, 2015

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

BR(1)