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OpenTrials
Completed

NCT Number: NCT03853668

Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting

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

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National heart institute

Giza, Cairo Governorate, 11262, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: cardiac rehabilitation

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: exercises

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2019
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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