HIIT for Inflammatory Rheumatic Disease: Man vs Machine
Primary Purpose
Inflammatory Rheumatism
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Effective endurance 4x4 training - Supervised
Effective endurance 4x4 training - APP
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Rheumatism focused on measuring VO2max, Cardiovascular health, Quality of life, Endurance exercise
Eligibility Criteria
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
Sites / Locations
- Myworkout - Medical Rehabilitation Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Supervised HIIT
APP HIIT
Arm Description
Exercise intervention, 20 supervised by healthcare professional
Exercise intervention, 20 self-monitored assisted by a mobilephone application
Outcomes
Primary Outcome Measures
Change in physiological measures
Maximal oxygen uptake
Secondary Outcome Measures
Change in health-related quality of life
Questionnaire (Norwegian RAND-36), scoring on a 0-100 scale with higher scores identifying better outcomes
Full Information
NCT ID
NCT04649528
First Posted
November 19, 2020
Last Updated
November 25, 2020
Sponsor
Molde University College
1. Study Identification
Unique Protocol Identification Number
NCT04649528
Brief Title
HIIT for Inflammatory Rheumatic Disease: Man vs Machine
Official Title
Digitally Assisted High-intensity Interval Training in Inflammatory Rheumatic Disease Patients: Treatment by Man or Machine?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
March 23, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molde University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Rheumatism
Keywords
VO2max, Cardiovascular health, Quality of life, Endurance exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial
Masking
Investigator
Masking Description
The exercise physiologist performing the maximal oxygen uptake pre and posttests was blinded with reguards to which intervention group the participants had been assigned.
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised HIIT
Arm Type
Experimental
Arm Description
Exercise intervention, 20 supervised by healthcare professional
Arm Title
APP HIIT
Arm Type
Experimental
Arm Description
Exercise intervention, 20 self-monitored assisted by a mobilephone application
Intervention Type
Behavioral
Intervention Name(s)
Effective endurance 4x4 training - Supervised
Intervention Description
Exercise intervention utilizing 4x4min aerobic high-intensity interval training
Intervention Type
Device
Intervention Name(s)
Effective endurance 4x4 training - APP
Intervention Description
Exercise intervention utilizing 4x4min aerobic high-intensity interval training
Primary Outcome Measure Information:
Title
Change in physiological measures
Description
Maximal oxygen uptake
Time Frame
At baseline and after 10 weeks of HIIT
Secondary Outcome Measure Information:
Title
Change in health-related quality of life
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Helgerud, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Myworkout - Medical Rehabilitation Clinic
City
Trondheim
State/Province
Please Select
ZIP/Postal Code
7047
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
34673536
Citation
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.
Results Reference
derived
Learn more about this trial
HIIT for Inflammatory Rheumatic Disease: Man vs Machine
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