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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

Tracking Information
First Submitted Date  ICMJE December 14, 2016
First Posted Date  ICMJE December 16, 2016
Last Update Posted Date November 13, 2018
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
Total body fat and total lean mass (body composition) [ Time Frame: Baseline, 3 months (right after intervention), 9 months ]
Body composition is measured as a change between timepoints and is measured by DXA.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interval Training Study in Psoriatic Arthritis
Official Title  ICMJE Interval Training Study in Psoriatic Arthritis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE Behavioral: interval training
4x4 high intensity interval training
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: interval training
  • No Intervention: controls
    No change in diet and training habits
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2016)
67
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02995460
Other Study ID Numbers  ICMJE 2012/1646
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Norwegian University of Science and Technology
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Norwegian University of Science and Technology
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Helse Midt-Norge
Investigators  ICMJE
Study Director: Siri Forsmo, md prof Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP