- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04639349
Effect of Home Exercise Activity on Cortisol and Depression in COPD During the Pandemic COVID
Effect of Home Exercise Activity on Cortisol and Depression in COPD Patients During the Pandemic COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt
- Recruiting
- Faculty of physical therapy cairo university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
|
Other: control group
The control group will not be trained
|
the control group will not be trained
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cortisol
Time Frame: It will be measured after eight weeks of training
|
it will be measured in plasma
|
It will be measured after eight weeks of training
|
|
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
|
It will be measured after eight weeks of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pulmonary function test
Time Frame: It will be measured after eight weeks of training
|
it will be a measurement for lung volume and capacities
|
It will be measured after eight weeks of training
|
|
Interleukin-8
Time Frame: It will be measured after eight weeks of training
|
It is an inflammatory marker in plasma
|
It will be measured after eight weeks of training
|
|
body mass index
Time Frame: It will be measured after eight weeks of training
|
it will measure body mass changes
|
It will be measured after eight weeks of training
|
|
six minute walking test
Time Frame: It will be measured after eight weeks of training
|
it assess functional capacity
|
It will be measured after eight weeks of training
|
|
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
|
It will be measured after eight weeks of training
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/002897
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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