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Completed

NCT Number: NCT04562857

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.

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Key information

Conditions

Sleep Deprivation Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National heart institute

Giza, Cairo Governorate, 11262, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have AF confirmed by ECG
  • Their ages range from 45 and 65 years of age
  • Medically stable patients.
  • Current complaint of poor Sleep quality (SQ) (score > 5 of the SQ scale)
  • 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.

Treatment and study plan

Moderate intensity interval training (MITT)

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.

Primary outcomes

  1. Sleep quality scores (0 is best, 3 is worst)

    Time frame: 10 weeks

    data about sleep from Pittsburgh sleep quality index questionnaire

  2. sleep latency (in min)

    Time frame: 10 weeks

    time spent in bed before falling asleep (from the actigraph)

  3. Total sleep time (in hours)

    Time frame: 10 weeks

    Total time actually slept (from the actigraph)

  4. Sleep fragmentation index (in %) (the more means worse)

    Time frame: 10 weeks

    Index of the level of the sleep continuity (from the actigraph)

  5. cutpoints

    Time frame: 10 weeks

    numbers displayed on the actigraph to give a picture about activity level

Secondary outcomes

  1. six minute walking distance (in meters)

    Time frame: 10 weeks

    represent aerobic capacity (distance walked in 6 min)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • National Heart Institute, Egypt
  • Swinburne University of Technology

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 24, 2020
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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