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

NCT ID: NCT04562857

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-12-10

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.

Conditions

Sleep Deprivation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Moderate intensity interval training (MITT)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Moderate intensity interval training (MITT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swinburne University of Technology

OTHER

Sponsor Role: collaborator

National Heart Institute, Egypt

OTHER_GOV

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hady Atef Labib

Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hady Balabel

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

National heart institute

Giza, Cairo Governorate, Egypt

Countries

Egypt

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

AF and sleep apnea

Identifier Type: -

Identifier Source: org_study_id