Chronic Obstructive Pulmonary DiseaseNCT04639349
Effect of Home Exercise Activity on Cortisol and Depression in COPD During the Pandemic COVID
A study testing exercise group in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Nov 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable COPD patients
- patients who will have a training device as bicycle or treadmill in home
Who cannot join
- diabetic patients
- renal patients.
- liver diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza, Dokki
Ali Ismail, lecturer, 02 01005154209, allooka2012@gmail.com
About this study
Official title: Effect of Home Exercise Activity on Cortisol and Depression in COPD Patients During the Pandemic COVID-19
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.
Read the 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- exercise group, control group
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise groupBehavioural
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 groupOther
the control group will not be trained
| Study group | Role | What they receive |
|---|---|---|
| Exercised group | Experimental | 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. Receives: Behavioral: exercise group |
| control group | Other | The control group will not be trained Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortisol
it will be measured in plasma
Measured: It will be measured after eight weeks of training
hospital anxiety and depression scale
this a questionnaire that will assess anxiety and depression in COPD patients
Measured: It will be measured after eight weeks of training
Secondary outcomes (5)
pulmonary function test
it will be a measurement for lung volume and capacities
Measured: It will be measured after eight weeks of training
Interleukin-8
It is an inflammatory marker in plasma
Measured: It will be measured after eight weeks of training
body mass index
it will measure body mass changes
Measured: It will be measured after eight weeks of training
six minute walking test
it assess functional capacity
Measured: It will be measured after eight weeks of training
St. George's respiratory questionnaire
It assess the effect of COPD on general quality of life
Measured: It will be measured after eight weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start19 Nov 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639349
- Sponsor's protocol ID
- P.T.REC/012/002897
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home Exercise Activity on Cortisol and Depression in COPD Patients During the Pandemic COVID-19
- ClinicalTrials.gov ID
- NCT04639349
- Acronym / sponsor ID
- P.T.REC/012/002897
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercised group | Experimental | Behavioral: exercise groupthe 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 | Other | Other: control groupThe control group will not be trained |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable COPD patients
- patients who will have a training device as bicycle or treadmill in home
Key exclusion criteria (3 listed)
- diabetic patients
- renal patients.
- liver diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise groupthe 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. | Behavioural | Exercised group |
| control groupthe control group will not be trained | Other | control group |
Primary outcome
cortisol
Time frame: It will be measured after eight weeks of training
it will be measured in plasma
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
5 secondary outcomes
pulmonary function test
Time frame: It will be measured after eight weeks of training
Interleukin-8
Time frame: It will be measured after eight weeks of training
body mass index
Time frame: It will be measured after eight weeks of training
six minute walking test
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise group in people with Chronic Obstructive Pulmonary Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortisol (time frame: It will be measured after eight weeks of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.