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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04639349

Collaborator

(none)

Enrollment

Location

Arms

3.4

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Behavioral: exercise group Other: control group	N/A

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

Study Type:

Interventional

Anticipated 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 :

Nov 19, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

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.
Other: control group The control group will not be trained	Other: control group the control group will not be trained

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

Other: control group

The control group will not be trained

Other: control group

the control group will not be trained

Outcome Measures

Primary Outcome Measures

cortisol [It will be measured after eight weeks of training]
it will be measured in plasma
hospital anxiety and depression scale [It will be measured after eight weeks of training]
this a questionnaire that will assess anxiety and depression in COPD patients

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Physical Therapy Cairo University	Giza	Dokki	Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ali Ismail, lecturer, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Nov 20, 2020

Last Update Posted:

Nov 20, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 20, 2020