NCT04304326

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.

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 Apr 2020

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

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

29 days

First QC Date

March 9, 2020

Last Update Submit

March 28, 2023

Conditions

Keywords

Functional trainingPhysical exercisePsoriatic arthritisQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, after 45 and 90 days

Secondary Outcomes (1)

  • Change in the quality of life

    Baseline, after 45 and 90 days

Study Arms (2)

Intervational

EXPERIMENTAL

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.

Other: Resistence Exercise

Arms and Interventions

EXPERIMENTAL

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.

Other: Resistence Exercise

Interventions

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.

Arms and InterventionsIntervational

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

Related Publications (1)

  • Silva DR, Meireles SM, Brumini C, Natour J. Effectiveness of functional training versus resistance exercise in patients with psoriatic arthritis: randomized controlled trial. Adv Rheumatol. 2023 Dec 13;63(1):58. doi: 10.1186/s42358-023-00342-y.

MeSH Terms

Conditions

Arthritis, PsoriaticMotor Activity

Condition Hierarchy (Ancestors)

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

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
Masking Details
Single (Outcomes Assessor)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

April 1, 2020

Primary Completion

April 30, 2020

Study Completion

July 30, 2020

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations