- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853668
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting (exercises)
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo
-
Giza, Cairo, Egypt, 11262
- National Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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:
|
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:
|
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
Sponsor
Investigators
- Principal Investigator: Hady Atef, Master, Assistant lecturer of physical therapy,Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sleep and Exercise
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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