NCT02995460

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

2.9 years

First QC Date

December 14, 2016

Last Update Submit

November 8, 2018

Conditions

Psoriatic Arthritis

Keywords

Exercise Therapy

Outcome Measures

Primary Outcomes (2)

  • Patient global assesment (PGA)

    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)

    The VO2 max is measured as a change between timepoints

    Baseline, 3 months (right after intervention), 9 months

Secondary Outcomes (2)

  • Total lean mass

    Baseline, 3 months (right after intervention), 9 months

  • Total body fat

    Baseline, 3 months (right after intervention), 9 months

Study Arms (2)

interval training

EXPERIMENTAL

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

controls

NO INTERVENTION

No change in diet and training habits

Interventions

interval trainingBEHAVIORAL

4x4 high intensity interval training

interval training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 29882634RESULT

  • 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.

    PMID: 30402265RESULT

  • Thomsen RS, Nilsen TIL, Haugeberg G, Sitter B, Kavanaugh A, Pedersen SJ, Hoff M. Changes of inflammation in patients with psoriatic arthritis after high intensity interval training assessed by ultrasound and MRI, a randomized controlled trial. BMC Musculoskelet Disord. 2023 Sep 19;24(1):743. doi: 10.1186/s12891-023-06871-3.

    PMID: 37726677DERIVED

  • 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.

    PMID: 29179748DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Siri Forsmo, md prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 16, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 13, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share