- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03853668
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting (exercises)
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Cairo
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Giza, Cairo, Egypten, 11262
- National Heart Institute
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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
Andra namn:
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Experimentell: 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.
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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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)
Tidsram: up to 12 months
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1.The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
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up to 12 months
|
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sleep fragmentation index to be assessed by actigraphy
Tidsram: up to 12 months
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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.
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up to 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Functional aerobic capacity to be assessed by 6 minute walk test (6MWT)
Tidsram: 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.
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6 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Hady Atef, Master, Assistant lecturer of physical therapy,Cairo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Sleep and Exercise
Plan för individuella deltagardata (IPD)
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