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History of Changes for Study: NCT02995460
Interval Training Study in Psoriatic Arthritis
Latest version (submitted November 8, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 14, 2016 None (earliest Version on record)
2 December 16, 2016 Outcome Measures and Study Status
3 June 11, 2018 Study Status and References
4 November 8, 2018 Study Status and References
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Study NCT02995460
Submitted Date:  December 14, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2012/1646
Brief Title: Interval Training Study in Psoriatic Arthritis
Official Title: Interval Training Study in Psoriatic Arthritis
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2016
Overall Status: Completed
Study Start: January 2013
Primary Completion: December 2015 [Actual]
Study Completion: December 2015 [Actual]
First Submitted: December 14, 2016
First Submitted that
Met QC Criteria:
December 14, 2016
First Posted: December 16, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 14, 2016
Last Update Posted: December 16, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Norwegian University of Science and Technology
Responsible Party: Sponsor
Collaborators: Helse Midt-Norge
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Psoriatic Arthritis
Keywords: Exercise Therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 67 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Siri Forsmo, md prof
Study Director
Norwegian University of Science and Technology
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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