Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting

NCT03853668 | Completed DMC

• 1 other identifier: Sleep and exercise
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Deprivation

Keywords

sleep quality; aerobic and resisted exercises; CABG

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  6 months

Study Arms (2)

aerobic exercise group

ACTIVE COMPARATOR

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)

Behavioral: exercise

aerobic and resisted exercise

EXPERIMENTAL

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.

Behavioral: exercise

Interventions

exercise BEHAVIORAL

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

Also known as: cardiac rehabilitation

aerobic and resisted exercise; aerobic exercise group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National heart institute

Giza, Cairo Governorate, 11262, Egypt

Location

MeSH Terms

Conditions

Sleep Deprivation; Sleep Initiation and Maintenance Disorders

Interventions

Exercise; Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hady Atef, Master

  Assistant lecturer of physical therapy,Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of physical therapy

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 26, 2019
• Study Start: January 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

EG (1)