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

Primary Purpose

Sleep Deprivation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Deprivation focused on measuring sleep quality, aerobic and resisted exercises, CABG

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National heart institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

aerobic exercise group

aerobic and resisted exercise

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)
1.The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
sleep fragmentation index to be assessed by actigraphy
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.

Secondary Outcome Measures

Functional aerobic capacity to be assessed by 6 minute walk test (6MWT)
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.

Full Information

First Posted
February 15, 2019
Last Updated
February 21, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03853668
Brief Title
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting
Acronym
exercises
Official Title
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Deprivation
Keywords
sleep quality, aerobic and resisted exercises, CABG

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aerobic exercise group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
aerobic and resisted exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
exercise
Other Intervention Name(s)
cardiac rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)
Description
1.The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
Time Frame
up to 12 months
Title
sleep fragmentation index to be assessed by actigraphy
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Functional aerobic capacity to be assessed by 6 minute walk test (6MWT)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have underwent CABG surgery since 6-8 weeks Their ages ranges from 40 and 80 years of age Medically stable patients. patients did CABG-only treatment (not combined with valve replacement surgery) Current complaint of poor Sleep quality (SQ) (score > 5 of the SQ scale) Body mass index ≤ 35 kg/m2 (no obstructive sleep apnea) Exclusion Criteria: Any patient is known to have any unstable medical condition History of chronic insomnia for at least one year before surgery Indication of receiving treatments for depression and anxiety Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hady Atef, Master
Organizational Affiliation
Assistant lecturer of physical therapy,Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National heart institute
City
Giza
State/Province
Cairo
ZIP/Postal Code
11262
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting

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