ClinicalTrials.gg
CompletedNCT04649528Updated Dec 2, 2020

HIIT for Inflammatory Rheumatic Disease: Man vs Machine

An interventional study of Effective endurance 4x4 training - Supervised and Effective endurance 4x4 training - APP in Inflammatory Rheumatism, sponsored by Molde University College. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-02.

Sponsored by Molde University College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 2018, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare two modes of delivering high-intensity interval training (HIIT) in a population with inflammatory rheumatic disease over 10 weeks. One group will recieved HIIT supervised by a healthcare professional, the other group will perform self-monitored HITT with guidance by a smarthpone application.

Read the detailed description

People with inflammatory rheumatic diseases (IRS) such as rheumatoid arthritis (RA), spondyloarthritis (SpA) and systemic lupus erythematosus (SLE) have been shown to have reduced cardiovascular fitness and quality of life than the general population. Cardiovascular health is the single most important factor of total mortality. It has been shown previously that individuals with IRS tolerate both endurance training, resulting in improvement in function and cardiovascular health while also having a positive effect on disease activity measured through inflammation, pain, joint health and fatigue. In recent years, studies have also been conducted that demonstrate both the safety and effect of aerobic 4x4min high-intensity interval training (HIIT) for patients with IRS.

This study will involve an intervention period consisting of 20 HIIT sessions. Participants are randomized into one of two training groups. One group will perform HIIT under the supervision of a healthcare professional. The other group will perform the same HIIT training with identical instructions, however they will be self-monitored with the aid and guidance of a mobilephone application.

The purpose of the intervention is to increase maximum oxygen uptake and improve quality of life. The intervention period will consist of 2 weekly sessions lasting approximately 35 minutes performed on non-consecutive days. The endurance training will consist of 4 intervals of 4 minutes duration, separated by a 3-4 minute active break and follows the principle of intensive aerobic interval training. Before and after the training period, identical testing (approximately 30-40 min) will be performed by both intervention groups. The testing will include measurements of work economy and maximal oxygen uptake in an endurance test. Additionally, quality of life questionnaires will be obtained.

02

Conditions studied

  • Inflammatory Rheumatism

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Keywords

  • VO2max
  • Cardiovascular health
  • Quality of life
  • Endurance exercise
03

In context

Rheumatic Fever

55 studies on the registry are indexed under Rheumatic Fever; 21 are open to participants now.

This study's enrollment of 49 is below the median of 70 across 28 interventional studies indexed under Rheumatic Fever.

Browse Rheumatic Fever studies →

Lead sponsor

Molde University College is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Inflammatory rheumatic disease

Exclusion criteria

Exclusion Criteria:

  • Inability to complete the testing procedures
  • Pregancy
  • Not able to perform exercise intervention
  • Planed surgeries or other plans during initial exercise intervention period than directly will effect the testing or training.
  • Access to a smartphone
  • Less than 80% compliance of planned training sessions
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Supervised HIIT

    Exercise intervention, 20 supervised by healthcare professional

    Behavioral: Effective endurance 4x4 training - Supervised

  • Experimental
    APP HIIT

    Exercise intervention, 20 self-monitored assisted by a mobilephone application

    Device: Effective endurance 4x4 training - APP

Interventions

  • BehavioralEffective endurance 4x4 training - Supervised

    Exercise intervention utilizing 4x4min aerobic high-intensity interval training

  • DeviceEffective endurance 4x4 training - APP

    Exercise intervention utilizing 4x4min aerobic high-intensity interval training

06

What researchers measure

Primary outcomes

  1. Change in physiological measures

    Maximal oxygen uptake

    Time frame: At baseline and after 10 weeks of HIIT

Secondary outcomes

  1. Change in health-related quality of life

    Questionnaire (Norwegian RAND-36), scoring on a 0-100 scale with higher scores identifying better outcomes

    Time frame: At baseline and after 10 weeks of HIIT

07

Study locations

1 site
  • Myworkout - Medical Rehabilitation Clinic
    Trondheim, Please Select 7047, Norway
08

References and documents

Publications

  • Haglo H, Wang E, Berg OK, Hoff J, Helgerud J. Smartphone-Assisted High-Intensity Interval Training in Inflammatory Rheumatic Disease Patients: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Oct 21;9(10):e28124. doi: 10.2196/28124. PubMed 34673536 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Mar 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2020
First posted
Dec 2, 2020
StartActual
Jan 3, 2018
Primary completionActual
Mar 23, 2018
CompletionActual
Mar 23, 2018
Last update
Dec 2, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04649528
Lead sponsor
Molde University College
Responsible party
Sponsor
First posted
Dec 2, 2020
Start date
Jan 3, 2018
Primary completion
Mar 23, 2018
Completion
Mar 23, 2018
Last update
Dec 2, 2020

Study contacts

Jan Helgerud, PhD
principal investigator · Norwegian University of Science and Technology

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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