Effects of Exercise Training in Patients With Atrial Fibrillation and Sleep Apnea: A Pilot Study

Not Applicable

Completed

• Conditions: Sleep Deprivation

• Registration Number: NCT04562857
• Lead Sponsor: Cairo University

Brief Summary

Background: There are still many gaps in research concerning the effect of different physical training modalities on sleep deprivation in the population with different types of sleep apnea. Aims: The purpose of this study was to examine the effect of moderate-intensity interval training (MITT) on patients with different types of sleep apnea.

Detailed Description

Methods: 15 Participants aged 45-65 years were randomized into two groups: obstructive sleep apnea group (OSA), and central sleep apnea group (CSA). The training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph together with the Pittsburg sleep quality index (PSQI) was used in sleep quality assessment. 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, filled PSQI, and did 6MWT before the first and last training sessions.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-19
• Study First Posted: 2020-09-24
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Patients who have AF confirmed by ECG
2. Their ages range from 45 and 65 years of age
3. Medically stable patients.
4. Current complaint of poor Sleep quality (SQ) (score > 5 of the SQ scale)
5. Patients who have OSA or CSA confirmed by polysomnography

Exclusion Criteria

• Any patient was known to have any unstable medical condition;or with any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise, was excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep fragmentation index (in %) (the more means worse)	10 weeks	Index of the level of the sleep continuity (from the actigraph)
cutpoints	10 weeks	numbers displayed on the actigraph to give a picture about activity level
Total sleep time (in hours)	10 weeks	Total time actually slept (from the actigraph)
Sleep quality scores (0 is best, 3 is worst)	10 weeks	data about sleep from Pittsburgh sleep quality index questionnaire
sleep latency (in min)	10 weeks	time spent in bed before falling asleep (from the actigraph)

Secondary Outcome Measures

Name	Time	Method
six minute walking distance (in meters)	10 weeks	represent aerobic capacity (distance walked in 6 min)

Trial Locations

Locations (1)

National heart institute; 🇪🇬 Giza, Cairo, Egypt