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Interval Training Study in Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
interval training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Exercise Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    interval training

    controls

    Arm Description

    4x4 high intensity interval training was performed on a stationary bicycle with a supervisor twice a week and by one self-training a week.

    No change in diet and training habits

    Outcomes

    Primary Outcome Measures

    Patient global assesment (PGA)
    PGA is measured as a change between timepoints. PGA is registered by the patient on a visual analog scale.
    Maximal oxygen uptake (VO2 max)
    The VO2 max is measured as a change between timepoints

    Secondary Outcome Measures

    Total lean mass
    Total lean mass is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
    Total body fat
    Total body fat is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).

    Full Information

    First Posted
    December 14, 2016
    Last Updated
    November 8, 2018
    Sponsor
    Norwegian University of Science and Technology
    Collaborators
    Helse Midt-Norge
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02995460
    Brief Title
    Interval Training Study in Psoriatic Arthritis
    Official Title
    Interval Training Study in Psoriatic Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (Actual)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology
    Collaborators
    Helse Midt-Norge

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriatic Arthritis
    Keywords
    Exercise Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    interval training
    Arm Type
    Experimental
    Arm Description
    4x4 high intensity interval training was performed on a stationary bicycle with a supervisor twice a week and by one self-training a week.
    Arm Title
    controls
    Arm Type
    No Intervention
    Arm Description
    No change in diet and training habits
    Intervention Type
    Behavioral
    Intervention Name(s)
    interval training
    Intervention Description
    4x4 high intensity interval training
    Primary Outcome Measure Information:
    Title
    Patient global assesment (PGA)
    Description
    PGA is measured as a change between timepoints. PGA is registered by the patient on a visual analog scale.
    Time Frame
    Baseline, 3 months (right after intervention), 9 months
    Title
    Maximal oxygen uptake (VO2 max)
    Description
    The VO2 max is measured as a change between timepoints
    Time Frame
    Baseline, 3 months (right after intervention), 9 months
    Secondary Outcome Measure Information:
    Title
    Total lean mass
    Description
    Total lean mass is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
    Time Frame
    Baseline, 3 months (right after intervention), 9 months
    Title
    Total body fat
    Description
    Total body fat is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).
    Time Frame
    Baseline, 3 months (right after intervention), 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Siri Forsmo, md prof
    Organizational Affiliation
    Norwegian University of Science and Technology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29882634
    Citation
    Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Impact of High-Intensity Interval Training on Disease Activity and Disease in Patients With Psoriatic Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Apr;71(4):530-537. doi: 10.1002/acr.23614.
    Results Reference
    result
    PubMed Identifier
    30402265
    Citation
    Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Effect of high-intensity interval training on cardiovascular disease risk factors and body composition in psoriatic arthritis: a randomised controlled trial. RMD Open. 2018 Oct 11;4(2):e000729. doi: 10.1136/rmdopen-2018-000729. eCollection 2018.
    Results Reference
    result
    PubMed Identifier
    29179748
    Citation
    Chronaiou I, Thomsen RS, Huuse EM, Euceda LR, Pedersen SJ, Hoff M, Sitter B. Quantifying bone marrow inflammatory edema in the spine and sacroiliac joints with thresholding. BMC Musculoskelet Disord. 2017 Nov 28;18(1):497. doi: 10.1186/s12891-017-1861-1.
    Results Reference
    derived

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    Interval Training Study in Psoriatic Arthritis

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