Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting

Sleep Deprivation Clinical Trial

— exercises  

Official title:

Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853668
• Other study ID #: Sleep and exercise
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Behavioral:
• exercise
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

Locations

Country	Name	City	State
Egypt	National heart institute	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 12 months
Primary	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.	up to 12 months
Secondary	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.	6 months