NCT04562857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

September 8, 2020

Last Update Submit

January 25, 2021

Conditions

Sleep Deprivation

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • six minute walking distance (in meters)

    10 weeks

Study Arms (2)

obstructive sleep apnea

ACTIVE COMPARATOR

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)

Central sleep apnea

ACTIVE COMPARATOR

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

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.

Central sleep apneaobstructive sleep apnea

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National heart institute

Giza, Cairo Governorate, 11262, Egypt

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Hady Balabel

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 24, 2020

Study Start

January 1, 2019

Primary Completion

December 10, 2019

Study Completion

December 10, 2019

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

After approval can be shared

Shared Documents
STUDY PROTOCOL
Time Frame
after 1 month for12 months
Access Criteria
will upload it to the journal of publication

Locations

EG(1)