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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Deprivation
• Intervention / Treatment: Behavioral: Moderate intensity interval training (MITT)

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Giza, Cairo, Egypt, 11262
      • National Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: obstructive sleep apnea; interval exercises (intervention) on bicycle for patients with AF and OSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.	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.
Active Comparator: Central sleep apnea; interval exercises (intervention) on bicycle for patients with AF and CSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
six minute walking distance (in meters)	represent aerobic capacity (distance walked in 6 min)	10 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Swinburne University of Technology; National Heart Institute, Egypt
• Investigators: Principal Investigator: Hady Balabel, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 19, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Arrhythmias, Cardiac; Atrial Fibrillation; Sleep Deprivation
• Other Study ID Numbers: AF and sleep apnea

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: After approval can be shared
• IPD Sharing Time Frame: after 1 month for12 months
• IPD Sharing Access Criteria: will upload it to the journal of publication
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No