NCT04048057

Brief Summary

There are studies showing the superiority of HIIT protocols in patients with CAD in the literature, however there is no consensus on the use of HIIT protocols in CAD patients. In addition, in these studies, the HIIT protocols differ in severity and duration and there is no optimal HIIT protocol. Therefore, this study was planed to investigate of two different HIIT protocols and one MICT protocols, which are more commonly used in patients with CAD in the literature on exercise capacity, quality of life, body composition, physical activity level and fear of movement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration 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

July 15, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

August 5, 2019

Last Update Submit

August 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • exercise capacity

    Cardiopulmonary exercise test

    15 minutes

Secondary Outcomes (4)

  • MacNew Health Related Quallity of Life Qustionnaire

    15 minutes

  • body composition

    1 minute

  • physical activity level

    15 minutes

  • fear of movement

    15 minutes

Study Arms (3)

Modarete Intensity Continous Training

EXPERIMENTAL
Other: Exercise

High Intensity Interval Training I

EXPERIMENTAL
Other: Exercise

High Intensity Interval Training II

EXPERIMENTAL
Other: Exercise

Interventions

Modarete Intensity Continous Training: Medium intensity continuous exercise training will be performed. Exercise intensity will be adjusted as 50-70% of maximal power. High Intensity Interval Training I: It will be four cycles consisting of 4 minute high intensity exercise phase and 3 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power. High Intensity Interval Training II: It will be 10 cycles consisting of 1 minute high intensity exercise phase and 1 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power.

High Intensity Interval Training IHigh Intensity Interval Training IIModarete Intensity Continous Training

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have undergone percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery,
  • Nonobstructive CAD registered by angiography
  • Left ventricular ejection fraction above 50%,
  • Clinically stable for more than 2 weeks in terms of symptoms and medical treatment.

You may not qualify if:

  • Ischemia symptoms,
  • Being in Class III-IV according to the New York Heart Classification,
  • Obtaining significant left ventricular outflow obstruction,
  • Ventricular arrhythmia,
  • Being marked valvular heart disease,
  • Failure to comply with exercise testing and training rules,
  • To have significant orthopedic or neurological comorbidity that prevents full participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Center, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kutahya Medical Sciences University

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 7, 2019

Study Start

July 15, 2019

Primary Completion

March 1, 2021

Study Completion

January 1, 2022

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations