NCT04649528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 19, 2020

Last Update Submit

November 25, 2020

Conditions

Inflammatory Rheumatism

Keywords

VO2maxCardiovascular healthQuality of lifeEndurance exercise

Outcome Measures

Primary Outcomes (1)

  • Change in physiological measures

    Maximal oxygen uptake

    At baseline and after 10 weeks of HIIT

Secondary Outcomes (1)

  • Change in health-related quality of life

    At baseline and after 10 weeks of HIIT

Study Arms (2)

Supervised HIIT

EXPERIMENTAL

Exercise intervention, 20 supervised by healthcare professional

Behavioral: Effective endurance 4x4 training - Supervised

APP HIIT

EXPERIMENTAL

Exercise intervention, 20 self-monitored assisted by a mobilephone application

Device: Effective endurance 4x4 training - APP

Interventions

Effective endurance 4x4 training - SupervisedBEHAVIORAL

Exercise intervention utilizing 4x4min aerobic high-intensity interval training

Supervised HIIT
Effective endurance 4x4 training - APPDEVICE

Exercise intervention utilizing 4x4min aerobic high-intensity interval training

APP HIIT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Inflammatory rheumatic disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Myworkout - Medical Rehabilitation Clinic

Trondheim, Please Select, 7047, Norway

Location

Related Publications (1)

  • 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.

    PMID: 34673536DERIVED

MeSH Terms

Conditions

Rheumatic Fever

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jan Helgerud, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The exercise physiologist performing the maximal oxygen uptake pre and posttests was blinded with reguards to which intervention group the participants had been assigned.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 2, 2020

Study Start

January 3, 2018

Primary Completion

March 23, 2018

Study Completion

March 23, 2018

Last Updated

December 2, 2020

Record last verified: 2020-11

Locations

NO(1)