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Effect of Home Exercise Activity on Cortisol and Depression in COPD During the Pandemic COVID

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ClinicalTrials.gov Identifier: NCT04639349
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Mohamed Ali ismail, Cairo University

Study Description
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Brief Summary:
exercise activity during the COVID pandemic is appreciated to be conducted in home especially for chronic chest diseases as chronic obstructive pulmonary disease (COPD) to reduce the chance of viral contamination during the COVID-19 pandemic.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: exercise group Other: control group Not Applicable

Detailed Description:

40 COPD men will be divided to exercise group (20 patients) and control group (20 patients):

the exercise group will receive a exercise session contains a fifty minutes exercise training at home with moderate intensity on the available training devices as bicycle or treadmill in addition to 30 minutes of exercising of upper and lower limb, the session will be repeated three times per week for eight weeks.

The control group will not be trained

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Home Exercise Activity on Cortisol and Depression in COPD Patients During the Pandemic COVID-19
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercised group
the exercise group (20 patients) will receive a exercise session contains a fifty minutes exercise training at home with moderate intensity on the available training devices as bicycle or treadmill in addition to 30 minutes of exercising of upper and lower limb, the session will be repeated three times per week for eight weeks.
 Behavioral: exercise group
the exercise group (20 patients) will receive a exercise session contains a fifty minutes exercise training at home with moderate intensity on the available training devices as bicycle or treadmill in addition to 30 minutes of exercising of upper and lower limb, the session will be repeated three times per week for eight weeks.
control group
The control group will not be trained
 Other: control group
the control group will not be trained


Outcome Measures
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Primary Outcome Measures :
  1. cortisol [ Time Frame: It will be measured after eight weeks of training ]
    it will be measured in plasma

  2. hospital anxiety and depression scale [ Time Frame: It will be measured after eight weeks of training ]
    this a questionnaire that will assess anxiety and depression in COPD patients


Secondary Outcome Measures :
  1. pulmonary function test [ Time Frame: It will be measured after eight weeks of training ]
    it will be a measurement for lung volume and capacities

  2. Interleukin-8 [ Time Frame: It will be measured after eight weeks of training ]
    It is an inflammatory marker in plasma

  3. body mass index [ Time Frame: It will be measured after eight weeks of training ]
    it will measure body mass changes

  4. six minute walking test [ Time Frame: It will be measured after eight weeks of training ]
    it assess functional capacity

  5. St. George's respiratory questionnaire [ Time Frame: It will be measured after eight weeks of training ]
    It assess the effect of COPD on general quality of life


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation of gender identity
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable COPD patients
  • patients who will have a training device as bicycle or treadmill in home

Exclusion Criteria:

  • diabetic patients
  • renal patients.
  • liver diseases
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639349


Contacts
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Contact: Ali Ismail, lecturer 02 01005154209 allooka2012@gmail.com

Locations
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Egypt
Faculty of Physical Therapy Cairo University Recruiting
Giza, Dokki, Egypt
Contact: Ali Ismail, lecturer    02 01005154209    allooka2012@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ali Ismail, lecturer Cairo University
More Information
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Responsible Party: Ali Mohamed Ali ismail, lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT04639349    
Other Study ID Numbers: P.T.REC/012/002897
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases