We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02995460
Previous Study | Return to List | Next Study

Interval Training Study in Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02995460
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : November 13, 2018
Sponsor:
Collaborator:
Helse Midt-Norge
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Behavioral: interval training Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interval Training Study in Psoriatic Arthritis
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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).

  2. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995460


Sponsors and Collaborators
Norwegian University of Science and Technology
Helse Midt-Norge
Investigators
Layout table for investigator information
Study Director: Siri Forsmo, md prof Norwegian University of Science and Technology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02995460    
Other Study ID Numbers: 2012/1646
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Norwegian University of Science and Technology:
Exercise Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
 Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases