NCT02905630

Brief Summary

This pilot study evaluates the effect of exercise training on CFR, functional capacity, heart rate variability, endothelial function and quality of life in patients with no obstructive coronary artery disease and angina.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

3.9 years

First QC Date

August 24, 2016

Last Update Submit

September 13, 2016

Conditions

Angina

Keywords

coronary flow reserveanginaexercise training

Outcome Measures

Primary Outcomes (1)

  • Coronary flow reserve

    Changes of Cornary flow reserve following 3 months of exercise training

    3 months

Secondary Outcomes (2)

  • Endothelial function

    3 months

  • Functional capacity

    3 months

Study Arms (2)

Exercise training

EXPERIMENTAL

High intensity aerobic exercise training

Other: Exercise training

No training

NO INTERVENTION

No exercise training, only ordinary daily life activities.

Interventions

Exercise trainingOTHER

high intensity aerobic interval training

Exercise training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • outpatients and patients admitted to the hospital with a history of repeated episodes of exercise induced chest pain.
  • normal or near normal coronary angiogram or negative CT coronary angiogram
  • age \> 18 years
  • being able to participate in training groups 3 times a week.

You may not qualify if:

  • serious valve disease
  • cancer
  • previous radiation or drug therapy for cancer
  • musculoskeletal problems making ET impossible
  • ongoing serious inflammatory disease
  • intracardiac devices
  • presumed insufficient acoustic windows because of severe emphysema or gross overweight
  • atrial fibrillation
  • participation in other ongoing studies.
  • contrast allergy
  • contraindication to adenosine infusion
  • vasospasm angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, 4068, Norway

RECRUITING

Related Publications (1)

  • Larsen AI, Saeland C, Vegsundvag J, Skadberg MS, Nilsen J, Butt N, Ushakova A, Valborgland T, Munk PS, Isaksen K. Aerobic high-intensity interval exercise training in patients with angina and no obstructive coronary artery disease: feasibility and physiological effects. Eur Heart J Open. 2023 Mar 22;3(2):oead030. doi: 10.1093/ehjopen/oead030. eCollection 2023 Mar.

    PMID: 37113515DERIVED

MeSH Terms

Conditions

Angina Pectoris

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alf Inge Larsen, MD, PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alf Inge Larsen, Md, PhD

CONTACT

004795889896laai@sus.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 19, 2016

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

September 19, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)