NCT04639349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 19, 2020

Last Update Submit

November 19, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • cortisol

    it will be measured in plasma

    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

    It will be measured after eight weeks of training

Secondary Outcomes (5)

  • pulmonary function test

    It will be measured after eight weeks of training

  • Interleukin-8

    It will be measured after eight weeks of training

  • body mass index

    It will be measured after eight weeks of training

  • six minute walking test

    It will be measured after eight weeks of training

  • St. George's respiratory questionnaire

    It will be measured after eight weeks of training

Study Arms (2)

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.

Behavioral: exercise group

control group

OTHER

The control group will not be trained

Other: control group

Interventions

exercise groupBEHAVIORAL

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.

Exercised group
control groupOTHER

the control group will not be trained

control group

Eligibility Criteria

Age50 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • diabetic patients
  • renal patients.
  • liver diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 20, 2020

Study Start

November 19, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

EG(1)