NCT03506984

Brief Summary

Participants had randomly divided into two equal groups. Group (A) had received a program of high intensity interval training 30-40 minutes three times per week for one month. The participant will start cycling slowly for five minute without resistance at the beginning of the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the speed with no resistance at the end of the exercise as cooling down. Group (B) will receive a program of inspiratory muscle training by using the threshold based inspiratory muscle trainer for 10-15 minute daily with frequency three times per week for four weeks.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

March 15, 2018

Last Update Submit

April 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compare between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating lipid profile ( cholesterol level mg/dl, triglyceride mg/dl, LDL mg/dl and HDL mg/dl) by using the blood analyzer in CAD risk factors

    Comparison between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating lipid profile which composed of ( cholesterol level mg/dl, triglyceride mg/dl, LDL mg/dl and HDL mg/dl) by using the blood analyzer (Photometer, 5010, boehinger) in Coronary Artery Disease risk factors

    after 4 weeks of the trial application

Secondary Outcomes (4)

  • Effect of high intensity interval training and Inspiratory Muscle Training on 6 minutes walking test by meter

    after 4 weeks of the trial application

  • Compare between the effect of High Intensity Interval Training versus Inspiratory Muscle Training on modulating hematocrit value by using the blood analyzer in CAD risk factors

    after 4 weeks of the trial application

  • Effect of high intensity interval training and Inspiratory Muscle Training on pulse rate (beat/min)

    after 4 weeks of the trial application

  • Effect of high intensity interval training and Inspiratory Muscle Training on modified BORG scale by meter

    after 4 weeks of the trial application

Study Arms (2)

Group A

EXPERIMENTAL

the participant will do a program of inspiratory muscle training for 10-15 minutes once daily using Threshold Inspiration Muscle Training Device

Device: Threshold Inspiration Muscle Training Device

Group B

EXPERIMENTAL

the participant will start cycling slowly for five minutes without resistance at the beginning of the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the speed with no resistance at the end of the exercise as cooling down using Electronic Bicycle Ergometer

Device: Electronic Bicycle Ergometer

Interventions

Threshold based trainer is a small handled device.It includes a mouthpiece and a calibrated spring loaded valve. The valve control a constant inspiratory pressure training load and the patient must generate a suffient inspiratory pressure in order for the inspiratory valve to be opened and allow the air to be inhaled. The amount of resistance can be adjusted by varying the compression of the spring-loaded valve. Adjustment from 9cmH2o to 41cmH2o.

Also known as: respironics,cedarGrove,NJ 07009-1201 Made in U.S.A
Group A

Electronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be used in High interval intensity training.

Also known as: Biodex LBC, made in New York
Group B

Eligibility Criteria

Age45 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • They will be 45-55 years old participants of males.
  • All of them had body mass index more than 30 kg/m2.
  • All of them were diagnosed as diabetic persons for at least 5 years.
  • All of them were diagnosed as a mild to moderate hypertensive persons for at least 5 years.
  • All of them had a reduction in walking capacity in relation to their height, age and body mass index (BMI).

You may not qualify if:

  • Unstable cardiac condition.
  • Patient who were on beta blocker.
  • Uncontrolled diabetes mellitus.
  • Mentally unstable person.
  • Patient with intermittent claudication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibri hospital

Ibri, Al Dhahra, 511, Oman

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Rana H Elbanna, master

    lecturer assistance at faculty of physical therapy at Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana H Elbanna, master

CONTACT

Sherif O Elabd, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the participant
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will randomely divided into two equal groups. Group (A) will receive a programe of high intensity interval training 30-40 minutes three times per week for one month.the participant will start cycling slowly for five minute without resistance at the beginning of the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the speed with no resistance at the end of the exercise as cooling down. The participant will be closely monitored by the handheld telemetry. Group (B) will receive a program of inspiratory muscle training by using the threshold based inspiratory muscle trainer for 10-15 minutesonce daily with frequency three times per week for four weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer assistance at faculty of physical therapy at Cairo University

Study Record Dates

First Submitted

March 15, 2018

First Posted

April 24, 2018

Study Start

September 1, 2017

Primary Completion

April 25, 2018

Study Completion

May 3, 2018

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations