Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting (exercises)

February 21, 2019 updated by: Hady Atef Labib, Cairo University
Background:There are still many gaps in research concerning the effect of different physical training modalities on sleep quality in the population underwent coronary artery bypass graft surgeries(CABG).Purpose:The present study was conducted to compare the quality of sleep in subjects who underwent CABG, were submitted to two types of training (i.e, aerobic exercise alone or combined aerobic and resistance training

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE/BACKGROUND:

There are still many gaps in research concerning the effect of different physical training modalities on sleep quality in the cardiac population. Thus, the objective of the present study was to compare the quality of sleep in subjects who underwent coronary artery bypass surgery submitted to two types of training (ie, aerobic exercise alone or combined aerobic and resistance training).

PATIENTS/METHODS:

80 Participants aged 45-65 years were randomized to two groups: aerobic group (AG), combined aerobic and resistance group (ARG). Training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) - Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored continuously while being recorded at one minute intervals. The participants kept the device for a period of 96 hours before the first and last training sessions.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Cairo
      • Giza, Cairo, Egypt, 11262
        • National Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who have underwent CABG surgery since 6-8 weeks
  2. Their ages ranges from 40 and 80 years of age
  3. Medically stable patients.
  4. patients did CABG-only treatment (not combined with valve replacement surgery)
  5. Current complaint of poor Sleep quality (SQ) (score > 5 of the SQ scale)
  6. Body mass index ≤ 35 kg/m2 (no obstructive sleep apnea)

Exclusion Criteria:

  1. Any patient is known to have any unstable medical condition
  2. History of chronic insomnia for at least one year before surgery
  3. Indication of receiving treatments for depression and anxiety
  4. Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: aerobic exercise group

aerobic exercises (intervention) on treadmill for 10 weeks, 3 times/week for duration of 30-45 min/session.

Exercise intensity is 50-65%of maximal heart rate (MHR)

control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks
Other Names:
  • cardiac rehabilitation
Experimental: aerobic and resisted exercise
combined resisted and aerobic exercises (intervention) for 10 weeks (circuit weight training and treadmill training respectively) 2 times/week for a duration of 30-45 min/session Exercise intensity is 50-65%of maximal heart rate (MHR) for aerobic part and 50% of 1 repetition maximum (1RM) for resistance part.
control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks
Other Names:
  • cardiac rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)
Time Frame: up to 12 months
1.The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
up to 12 months
sleep fragmentation index to be assessed by actigraphy
Time Frame: up to 12 months
2.Actigraphy is a valid tool to assist in determining sleep patterns in normal, healthy adult populations, normal infants and children, and patients suspected of certain sleep disorders.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional aerobic capacity to be assessed by 6 minute walk test (6MWT)
Time Frame: 6 months
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hady Atef, Master, Assistant lecturer of physical therapy,Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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