HIIT for Inflammatory Rheumatic Disease: Man vs Machine

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

Study Overview

• Status: Completed
• Conditions: Inflammatory Rheumatism
• Intervention / Treatment: Behavioral: Effective endurance 4x4 training - Supervised; Device: Effective endurance 4x4 training - APP

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised HIIT; Exercise intervention, 20 supervised by healthcare professional	Behavioral: Effective endurance 4x4 training - Supervised; Exercise intervention utilizing 4x4min aerobic high-intensity interval training
Experimental: APP HIIT; Exercise intervention, 20 self-monitored assisted by a mobilephone application	Device: Effective endurance 4x4 training - APP; Exercise intervention utilizing 4x4min aerobic high-intensity interval training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in physiological measures	Maximal oxygen uptake	At baseline and after 10 weeks of HIIT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health-related quality of life	Questionnaire (Norwegian RAND-36), scoring on a 0-100 scale with higher scores identifying better outcomes	At baseline and after 10 weeks of HIIT

Collaborators and Investigators

• Sponsor: Molde University College
• Investigators: Principal Investigator: Jan Helgerud, PhD, Norwegian University of Science and Technology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): March 23, 2018
• Study Completion (Actual): March 23, 2018

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; VO2max; Endurance exercise; Cardiovascular health
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Rheumatic Diseases; Collagen Diseases; Rheumatic Fever
• Other Study ID Numbers: HHRevma1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No