Interval Training Study in Psoriatic Arthritis

November 8, 2018 updated by: Norwegian University of Science and Technology

Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced physical function. Patients have a higher risk of cardiovascular disease and a higher body mass index.

A pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation after 12 weeks of high-intensity interval training.

The primary aim of this study is to determine whether high-intensity interval training affects the disease activity in psoriatic arthritis. This intervention is believed to result in benefits in terms of inflammation, body composition and risk factors for cardiovascular disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fulfilling the CASPAR criteria of psoriatic arthritis
  • ability to exercise.

Exclusion Criteria:

  • Inability to exercise
  • very high disease Activity
  • unstable ischemic cardiovascular disease
  • severe pulmonary disease
  • pregnancy
  • breastfeeding
  • drug- and alcohol addictions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: interval training
4x4 high intensity interval training was performed on a stationary bicycle with a supervisor twice a week and by one self-training a week.
Behavioral: interval training
4x4 high intensity interval training
NO_INTERVENTION: controls
No change in diet and training habits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient global assesment (PGA)
Time Frame: Baseline, 3 months (right after intervention), 9 months
PGA is measured as a change between timepoints. PGA is registered by the patient on a visual analog scale.
Baseline, 3 months (right after intervention), 9 months
Maximal oxygen uptake (VO2 max)
Time Frame: Baseline, 3 months (right after intervention), 9 months
The VO2 max is measured as a change between timepoints
Baseline, 3 months (right after intervention), 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total lean mass
Time Frame: Baseline, 3 months (right after intervention), 9 months
Total lean mass is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
Baseline, 3 months (right after intervention), 9 months
Total body fat
Time Frame: Baseline, 3 months (right after intervention), 9 months
Total body fat is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
Baseline, 3 months (right after intervention), 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Helse Midt-Norge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 8, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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