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Effects of upper limb resistance exercises on Aerobic capacity, Strength and Quality of life (QOL) in COPD patients

Protocol summary

Study aim
This study will be conducted to evaluate the effectiveness of upper limb Resistance exercises (aerobic capacity, strength and quality of life among COPD patients)
Design
A Randomized Controlled Trial will be conducted. Informed consent will be taken from patients by informing the aims and objectives of the study. Then patients will be selected on the basis of convenient sampling technique that will be randomized through the lottery method.
Settings and conduct
Nusrat Fateh Ali Khan Hospital and General Hospital, Faisalabad.
Participants/Inclusion and exclusion criteria
Inclusion:  Age of patients taken is 25-55 years  Patients of both genders  Individuals with stable COPD(Chronic bronchitis, Emphysema, asthma) being monitored by pulmonologist Exclusion: • MSK (frozen shoulder, osteoarthritis, rheumatoid arthritis, , traumatic fractures, amputation) • Cardiac issues • Surgery (Thoracic surgery, CABG) • Cognitively impaired dementia Peripheral oxygen saturation <90% during 6 min. walk test.
Intervention groups
The control group will warm-up with slow walking, deep breathing and arm circles for 5-15 minutes. Aerobic exercise and inspiratory muscle training will be performed for 5-15 minutes, involving three sets with 10 repititions and a rest interval of 1-2 minute with threshold strength instruments. At the end of session stretching will be performed for 5-10 minutes. The treatment group will perform the same physical exercises routine as the control group, with additional upper limb resistance exercise in three sets with 10 repititions with rest interval of 1-2 minutes between each sets which will be followed by message therapy
Main outcome variables
• Modified Borg Scale • Stethoscope • 6 min. walk test • QoL questionnaire • Dynamometer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220930056062N4
Registration date: 2024-06-10, 1403/03/21
Registration timing: prospective

Last update: 2024-06-10, 1403/03/21
Update count: 0
Registration date
2024-06-10, 1403/03/21
Registrant information
Name
Kaiynat Shafique
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 334 6925051
Email address
kaiynatshafique@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-18, 1403/03/29
Expected recruitment end date
2024-07-30, 1403/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of upper limb resistance exercises on Aerobic capacity, Strength and Quality of life (QOL) in COPD patients
Public title
Upper limb resistance exercises for COPD patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age of patients taken is 25-55 years Patients of both genders Individuals with stable COPD(Chronic bronchitis, Emphysema, asthma) being monitored by pulmonologist
Exclusion criteria:
MSK (frozen shoulder, osteoarthritis, rheumatoid arthritis, , traumatic fractures, amputation)• Cardiac (Angina pectoris, recent MI, severe pulmonary hypertension, CHF, Unstable diabetes, Severe exercise-induced hypoxemia) • . Surgery (Thoracic surgery, CABG) Cognitively impaired dementia Peripheral oxygen saturation <90% during 6 min. walk test
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization through lottery method. Each participant will be asked to choose between two pieces of paper labeled "Group A" and "Group B." They will be assigned to treatment groups based on the paper they select.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blind in this clinical trial. In this single-blinded RCT study, participants will be unaware of which treatment they are receiving. To ensure blinding, the treatments will be somewhat similar. The allocation sequence will be concealed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Government College University Faisalabad
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2024-05-25, 1403/03/05
Ethics committee reference number
GCUF/2024/9256

Health conditions studied

1

Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Exertion
Timepoint
Assessment will be made two time before and after 4 weeks
Method of measurement
Modified Borg Scale

2

Description
6 min. walk test
Timepoint
Assessment will be made two time before and after 4 weeks
Method of measurement
6 min. walk test

3

Description
quality of life
Timepoint
Assessment will be made two time before and after 4 weeks
Method of measurement
St. George’s Respiratory Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Aerobic exercise and inspiratory muscle training will be performed for 5-15 minutes, involving three sets with 10 repititions and a rest interval of 1-2 minute with threshold strength instruments, with additional upper limb resistance exercise in three sets with 10 repititions with rest interval of 1-2 minutes between each sets which will be followed by message therapy
Category
Rehabilitation

2

Description
Control group: The control group will warm-up with slow walking, deep breathing and arm circles for 5-15 minutes. Aerobic exercise and inspiratory muscle training will be performed for 5-15 minutes, involving three sets with 10 repetitions and a rest interval of 1-2 minute with threshold strength instruments. At the end of session stretching will be performed for 5-10 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Nusrat Fateh Ali Khan Hospital
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210092
Email
rafiaimtiaz@gcuf.edu.pk

2

Recruitment center
Name of recruitment center
General Hospital
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210092
Email
rafiaimtiaz@gcuf.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
3800
Phone
+92 41 9210023
Email
rafiaimtiaz@gcuf.edu.pk
Grant name
It is a self funded study. All financial expenses are bear personally
Grant code / Reference number
It is a self funded study. All financial expenses are bear personally
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
It is a self funded study. All financial expenses are bear personally
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200876
Email
rafiaimtiaz@gcuf.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
punjab
Postal code
38000
Phone
+92 41 9200886
Email
rafiaimtiaz@gcuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200886
Email
rafiaimtiaz@gcuf.edu.pk

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No - There is not a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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