NCT01478334

Brief Summary

The primary aim of the study is to investigate if 10 weeks of high intensity interval training improve inflammatory status in patients with rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

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

March 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

September 7, 2011

Last Update Submit

May 28, 2015

Conditions

Rheumatoid Arthritis

Keywords

High intensity exercisecardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

  • Inflammatory markers in blood

    C-reactive Protein (CRP), TNF-alfa, COMP, Pentraxin 3 using ELISA Whole-genome gene expression in blood cells using RNA(HumanHT-12 v4 Expression BeadChip)

    10 weeks

Secondary Outcomes (6)

  • Endothelial function

    10 weeks

  • quality of life

    10 weeks

  • HDL

    10 weeks

  • Total Cholesterol

    10 weeks

  • Blood glucose

    10 weeks

  • +1 more secondary outcomes

Study Arms (2)

Exercise then control

EXPERIMENTAL
Behavioral: high intensity interval training

Control then exercise

EXPERIMENTAL
Behavioral: Control

Interventions

high intensity interval trainingBEHAVIORAL

First 10 week of high intensity interval training, twice a week. The interval training session consists of 10 minutes warm up at 70 percent of maximal heart rate and continues with 4 times 4 minutes of high intensity intervals at 90 to 95 percent of maximal heart rate separated by 3 minutes of active brakes in between at 70 percent of maximal heart rate. Training will be performed by cycling. Training intensity will be supervised through the use of polar puls monitors and the BORG scale of subjective perceived exhaustion. Second 10 weeks participants are instructed not to change their dietary patterns or physical activity levels during the study period.

Exercise then control
ControlBEHAVIORAL

First 10 weeks participants are instructed not to change their dietary patterns or physical activity levels, and to continue their habitually lifestyle. Second 10 week of high intensity interval training, twice a week. The interval training session consists of 10 minutes warm up at 70 percent of maximal heart rate and continues with 4 times 4 minutes of high intensity intervals at 90 to 95 percent of maximal heart rate separated by 3 minutes of active brakes in between at 70 percent of maximal heart rate. Training will be performed by cycling. Training intensity will be supervised through the use of polar puls monitors and the BORG scale of subjective perceived exhaustion.

Control then exercise

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to exercise
  • written consent

You may not qualify if:

  • Inability to exercise
  • Known ischemic cardiovascular disease
  • Severe pulmonary disease
  • High activity level
  • Pregnancy
  • drug/alcohol abuse
  • Unstable RA
  • diagnosis before 2000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology, Faculty of medicine, Department of circulation and medical imaging,

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Sandstad J, Stensvold D, Hoff M, Nes BM, Arbo I, Bye A. The effects of high intensity interval training in women with rheumatic disease: a pilot study. Eur J Appl Physiol. 2015 Oct;115(10):2081-9. doi: 10.1007/s00421-015-3186-9. Epub 2015 May 27.

    PMID: 26013051RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dorthe Stensvold

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 7, 2011

First Posted

November 23, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

May 1, 2012

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

NO(1)