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Completed

NCT Number: NCT04649528

HIIT for Inflammatory Rheumatic Disease: Man vs Machine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Myworkout - Medical Rehabilitation Clinic

Trondheim, Please Select, 7047, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inflammatory rheumatic disease

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

Treatment and study plan

Effective endurance 4x4 training - Supervised

Behavioral

Exercise intervention utilizing 4x4min aerobic high-intensity interval training

Effective endurance 4x4 training - APP

Device

Exercise intervention utilizing 4x4min aerobic high-intensity interval training

Primary outcomes

  1. Change in physiological measures

    Time frame: At baseline and after 10 weeks of HIIT

    Maximal oxygen uptake

Secondary outcomes

  1. Change in health-related quality of life

    Time frame: At baseline and after 10 weeks of HIIT

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

Sponsors and collaborators

Lead sponsor

Molde University College

Other

Registry information

Official study title

Digitally Assisted High-intensity Interval Training in Inflammatory Rheumatic Disease Patients: Treatment by Man or Machine?

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2020
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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