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CompletedNCT04562857Updated Jan 27, 2021

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

An interventional study of Moderate intensity interval training (MITT) in Sleep Deprivation, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jan 2019, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sleep Deprivation
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In context

Sleep Deprivation

300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.

This study's enrollment of 19 is below the median of 45 across 248 interventional studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
19 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • BehavioralModerate 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.

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What researchers measure

Primary outcomes

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

    data about sleep from Pittsburgh sleep quality index questionnaire

    Time frame: 10 weeks

  2. sleep latency (in min)

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

    Time frame: 10 weeks

  3. Total sleep time (in hours)

    Total time actually slept (from the actigraph)

    Time frame: 10 weeks

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

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

    Time frame: 10 weeks

  5. cutpoints

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

    Time frame: 10 weeks

Secondary outcomes

  1. six minute walking distance (in meters)

    represent aerobic capacity (distance walked in 6 min)

    Time frame: 10 weeks

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Study locations

1 site
  • National heart institute
    Giza, Cairo 11262, Egypt
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References and documents

Study documents

  • Informed consent form · Jan 1, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — After approval can be shared

Supporting information: Study protocol

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04562857
Lead sponsor
Cairo University
Collaborators
Swinburne University of Technology, National Heart Institute, Egypt
Responsible party
Hady Atef Labib (Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy, Cairo University) — Principal investigator
First posted
Sep 24, 2020
Start date
Jan 1, 2019
Primary completion
Dec 10, 2019
Completion
Dec 10, 2019
Last update
Jan 27, 2021

Study contacts

Hady Balabel
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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