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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
exercise group
control group
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Exercised group

control group

Arm Description

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.

The control group will not be trained

Outcomes

Primary Outcome Measures

cortisol
it will be measured in plasma
hospital anxiety and depression scale
this a questionnaire that will assess anxiety and depression in COPD patients

Secondary Outcome Measures

pulmonary function test
it will be a measurement for lung volume and capacities
Interleukin-8
It is an inflammatory marker in plasma
body mass index
it will measure body mass changes
six minute walking test
it assess functional capacity
St. George's respiratory questionnaire
It assess the effect of COPD on general quality of life

Full Information

First Posted
November 19, 2020
Last Updated
November 19, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04639349
Brief Title
Effect of Home Exercise Activity on Cortisol and Depression in COPD During the Pandemic COVID
Official Title
Effect of Home Exercise Activity on Cortisol and Depression in COPD Patients During the Pandemic COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercised group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
The control group will not be trained
Intervention Type
Behavioral
Intervention Name(s)
exercise group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
the control group will not be trained
Primary Outcome Measure Information:
Title
cortisol
Description
it will be measured in plasma
Time Frame
It will be measured after eight weeks of training
Title
hospital anxiety and depression scale
Description
this a questionnaire that will assess anxiety and depression in COPD patients
Time Frame
It will be measured after eight weeks of training
Secondary Outcome Measure Information:
Title
pulmonary function test
Description
it will be a measurement for lung volume and capacities
Time Frame
It will be measured after eight weeks of training
Title
Interleukin-8
Description
It is an inflammatory marker in plasma
Time Frame
It will be measured after eight weeks of training
Title
body mass index
Description
it will measure body mass changes
Time Frame
It will be measured after eight weeks of training
Title
six minute walking test
Description
it assess functional capacity
Time Frame
It will be measured after eight weeks of training
Title
St. George's respiratory questionnaire
Description
It assess the effect of COPD on general quality of life
Time Frame
It will be measured after eight weeks of training

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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