Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04649528 |
| Other study ID # |
HHRevma1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2018 |
| Est. completion date |
March 23, 2018 |
Study information
| Verified date |
November 2020 |
| Source |
Molde University College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
