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The Effect of Eccentric Exercise on the Respiratory Capacities , Physical Function and Quality of Life Patients with Chronic Obstructive Pulmonary Disease

Protocol summary

Summary
Chronic obstructive pulmonary disease (COPD) is one of the serious and growing health problems. One of the serious problems in COPD patients is respiratory failure but it is not the only factor that affects patient's physical ability. Due to recent studies early skeletal muscle fatigue is considered as the main factor for limiting the patient's ability to perform physical activities. The purpose of this RCT is to evaluate the effects of eccentric exercises on respiratory capacities physical function and quality of life patients with COPD. Inclusion criteria are COPD, 40-70 years old, stable medical condition, ability to do exercise, Lack of orthopedic, neurological and cardiac disease and also no history of taking Coumadin and thorax surgery. Exclusion criteria are very sever COPD, any systemic disorder, according to the patient and the physician that lead to a change in therapy for the next two months, patients tendency to leave the study, unstable vital signs during the eccentric exercise, unusual living affairs, incompletion of treatment and evaluation programs. There are two groups in this study, (1) eccentric exercise group (eccentric exercise program with treadmill for 10 weeks),(2)control group (conventional drug therapy). In addition to demographic characteristics, smoking history, type of COPD disease, history of COPD, as well as heart rate, blood pressure, FEV1, QOL for COPD patients questionnaire (SGRQ), timed up & Go test, 6-minute walk (6MWT) and stair climbing test will be assessed pre and poat intervention in both groups.

General information

Acronym
Exercise therapy and COPD
IRCT registration information
IRCT registration number: IRCT201303315486N3
Registration date: 2013-08-11, 1392/05/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Azar Moezy
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
moeziazr@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences ( Vice chancellor for research ) research@tums.ac.ir
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eccentric Exercise on the Respiratory Capacities , Physical Function and Quality of Life Patients with Chronic Obstructive Pulmonary Disease
Public title
Exercise therapy on Patients with COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Sever COPD, 40-70 years old, Stable medical condition, Ability to do exercise, No need for oxygen therapy , Lack of other lung diseases, Lack of infectious diseases during the past three months. Lack of heart disease, Lack of mental disorders, Lack of orthopedic diseases, Lack of neurological disease, Lack of morbid obesity, Absence of acute exacerbation within recent 4 weeks, Not participate in sports and rehabilitation program over the last 3 months, No history of taking Coumadin, No history of thorax surgery. Exclusion criteria: Very sever COPD,( FEV1<30% predicted or FEV1<50%predicted plus chronic respiratory failure) Any systemic disorder according to the patient and the physician that lead to a change in therapy for the next two months, Patients tendency to leave the study, Unstable vital signs during the eccentric exercise, Unusual living affairs during the study, In-completion of treatment and evaluation programs.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized clinical trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz blvd- Quods Street
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
21659

Health conditions studied

1

Description of health condition studied
COPD
ICD-10 code
J44-47
ICD-10 code description
Chronic lower respiratory diseases

Primary outcomes

1

Description
Respiratory Capacities
Timepoint
pre and post intervention
Method of measurement
Spirometery

2

Description
Physical Function
Timepoint
pre and post intervention
Method of measurement
Functional tests

3

Description
Quality of Life in COPD patient
Timepoint
pre and post intervention
Method of measurement
St George's Respiratory Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Eccentric training will be consisted of downhill walking on a treadmill regularly 3 times a week for 10 weeks . During each session before beginning any training, a warm up protocol (15 minutes walking accompanied with static stretching for the quadriceps, hamstrings, calf muscles ) will be used. Obviously speed and duration of walking on the treadmill will be progressive during the study.
Category
Rehabilitation

2

Description
Conventional drug treatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Medicine and exercise sciences Department, Rasoule Akram Hospital,
Full name of responsible person
Dr Azar Moezy
Street address
Rasoule Akram Hospital, Tehran University of Medical Sciences , Sattarkhan Ave, Niayesh St,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research -Tehran University of Medical Sciences
Full name of responsible person
Ms Azoun
Street address
Keshavarz Blvd-Quods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research -Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr Azar Moezy
Position
PhD - assistant prof.
Other areas of specialty/work
Street address
Sports Medicine Clinic-azrat rasol akram hospital , Neyaesh Street
City
Tehran
Postal code
14455613131
Phone
+98 21 6435 2446
Fax
Email
moeziazr@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Azar Moezy
Position
PhD - assistant prof.
Other areas of specialty/work
Street address
Hazrat rasol akram hospital ,sport medicine clinic,Neyaesh Street
City
Tehran
Postal code
14455613131
Phone
+98 21 6435 2446
Fax
Email
moeziazr@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr Azar Moezy
Position
PhD - assistant prof.
Other areas of specialty/work
Street address
Hazrat rasol akram hospital ,sport medicine clinic.Neyaesh Street
City
Tehran
Postal code
14455613131
Phone
+98 21 6435 2446
Fax
Email
moeziazr@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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