Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date March 23, 2018
Est. primary completion date March 23, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Effective endurance 4x4 training - Supervised
Exercise intervention utilizing 4x4min aerobic high-intensity interval training
Device:
Effective endurance 4x4 training - APP
Exercise intervention utilizing 4x4min aerobic high-intensity interval training

Locations

Country Name City State
Norway Myworkout - Medical Rehabilitation Clinic Trondheim Please Select

Sponsors (1)

Lead Sponsor Collaborator
Molde University College

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in physiological measures Maximal oxygen uptake At baseline and after 10 weeks of HIIT
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03216616 - Guided Self-Management Intervention Targeting Fatigue in Rheumatic Inflammatory Diseases N/A
Completed NCT02164214 - Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)? Phase 3
Recruiting NCT04602091 - Observational Study in Patients Treated With JAK Inhibitors for Inflammatory Rheumatism (MAJIK)
Completed NCT04998955 - MST in Patients With Inflammatory Rheumatic Disease N/A
Completed NCT04806867 - Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia
Recruiting NCT04664465 - PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Terminated NCT04510467 - Mental Health Consequences of COVID19 Infection in the French RMD Cohort
Active, not recruiting NCT05283096 - Survey About Diet in Chronic Inflammatory Rheumatic Diseases
Recruiting NCT02719314 - Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Recruiting NCT04733079 - Treat-to-target by Email During Urate-lowering Therapy in Gout N/A
Not yet recruiting NCT06395883 - Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease
Completed NCT01511341 - Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases N/A