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

Sleep Deprivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562857
• Other study ID #: AF and sleep apnea
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Sleep Deprivation

Intervention

Behavioral:
• Moderate intensity interval training (MITT)
interval exercises (intervention) on bicycle for patients with AF and OSA or AF with CSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.

Locations

Country	Name	City	State
Egypt	National heart institute	Giza	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	National Heart Institute, Egypt, Swinburne University of Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep quality scores (0 is best, 3 is worst)	data about sleep from Pittsburgh sleep quality index questionnaire	10 weeks
Primary	sleep latency (in min)	time spent in bed before falling asleep (from the actigraph)	10 weeks
Primary	Total sleep time (in hours)	Total time actually slept (from the actigraph)	10 weeks
Primary	Sleep fragmentation index (in %) (the more means worse)	Index of the level of the sleep continuity (from the actigraph)	10 weeks
Primary	cutpoints	numbers displayed on the actigraph to give a picture about activity level	10 weeks
Secondary	six minute walking distance (in meters)	represent aerobic capacity (distance walked in 6 min)	10 weeks