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

Primary Purpose

Sleep Deprivation

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Moderate intensity interval training (MITT)

About this trial

This is an interventional treatment trial for Sleep Deprivation

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National heart institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

obstructive sleep apnea

Central sleep apnea

Arm Description

interval exercises (intervention) on bicycle for patients with AF and OSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.

interval exercises (intervention) on bicycle for patients with AF and CSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.

Outcomes

Primary Outcome Measures

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

data about sleep from Pittsburgh sleep quality index questionnaire

sleep latency (in min)

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

Total sleep time (in hours)

Total time actually slept (from the actigraph)

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

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

cutpoints

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

Secondary Outcome Measures

six minute walking distance (in meters)

represent aerobic capacity (distance walked in 6 min)

Full Information

NCT ID

NCT04562857

First Posted

September 8, 2020

Last Updated

January 25, 2021

Sponsor

Cairo University

Collaborators

Swinburne University of Technology, National Heart Institute, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT04562857

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

December 10, 2019 (Actual)

Study Completion Date

December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Swinburne University of Technology, National Heart Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

obstructive sleep apnea

Arm Type

Active Comparator

Arm Description

interval exercises (intervention) on bicycle for patients with AF and OSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.

Arm Title

Central sleep apnea

Arm Type

Active Comparator

Arm Description

interval exercises (intervention) on bicycle for patients with AF and CSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.

Intervention Type

Behavioral

Intervention Name(s)

Moderate intensity interval training (MITT)

Intervention Description

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 Outcome Measure Information:

Title

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

Description

data about sleep from Pittsburgh sleep quality index questionnaire

Time Frame

10 weeks

Title

sleep latency (in min)

Description

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

Time Frame

10 weeks

Title

Total sleep time (in hours)

Description

Total time actually slept (from the actigraph)

Time Frame

10 weeks

Title

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

Description

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

Time Frame

10 weeks

Title

cutpoints

Description

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

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

six minute walking distance (in meters)

Description

represent aerobic capacity (distance walked in 6 min)

Time Frame

10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hady Balabel

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

National heart institute

City

Giza

State/Province

Cairo

ZIP/Postal Code

11262

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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