Sleep DeprivationexercisesNCT03853668
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting
A study testing exercise in people with Sleep Deprivation, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Sleep Deprivation
- Being tested
- exercise
- Keywords
- sleep quality, aerobic and resisted exercises, CABG
- Medical subject headings
- Sleep Deprivation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Also called cardiac rehabilitation
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 12 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Jan 2018
- Primary completion1 Apr 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hady Atef Labib, Cairo University
- Investigators
- Hady Atef, Master, Principal investigator, Assistant lecturer of physical therapy,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853668
- Sponsor's protocol ID
- Sleep and exercise
- Acronym
- exercises
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT03853668
- Acronym / sponsor ID
- exercises / Sleep and exercise
- Conditions
- Sleep Deprivation
- Keywords
- sleep quality, aerobic and resisted exercises, CABG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise group | Active comparator | Behavioral: exerciseaerobic 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) |
| aerobic and resisted exercise | Experimental | Behavioral: exercisecombined 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseAlso: cardiac rehabilitationcontrol group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks | Behavioural | aerobic and resisted exercise, aerobic exercise group |
Primary outcome
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.
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.
1 secondary outcome
Functional aerobic capacity to be assessed by 6 minute walk test (6MWT)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hady Atef, Master principal investigator
Assistant lecturer of physical therapy,Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Sleep Deprivation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI) (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.