Effect of Extremity Exercise in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosed cases of COPD
- COPD secondary to any disease
- Age 10-70 years
- COPD in any stage according to GOLD classification
Exclusion Criteria:
- Taking any other form of alternative therapies
- The neurological deficit with the inability to understand of following instructions
- Recent Cardiovascular surgery patients
- Unstable angina patients
- Patients with musculoskeletal deficits
Sites / Locations
- Snehil Dixit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Unsupported Upper extremity exercise
Lower extremity exercise
Control
Arm Description
Specially designed unsupported Arm exercises will be done for the population with a rating of somewhat hard 13-14 (Original scale) will be used as a guideline for intensity
Specially designed Lower extremity exercises will be done for the population with a rating of somewhat hard 13-14 (Original scale) will be used as a guideline for intensity
Here no active intervention will be given only standard care as prescribed by the hospital will be given
Outcomes
Primary Outcome Measures
Airway Questionnaire 20
The Airway Questionnaire 20 (AQ20) was developed for patients with asthma and chronic obstructive pulmonary disease (COPD). It contains 20 items, with scores ranging from 0 to 20 - high scores indicate poor QOL. It takes only a few minutes to complete and has been validated in asthma and COPD patients.
Borg's scale and Medical Research Council scale (MRC) for dyspnea
The Borg Rating of Perceived Exertion (RPE) scale will help you estimate how hard you're working (your activity intensity). Perceived exertion is how hard you think your body is exercising. Ratings on this scale are related to heart rate (how hard your heart is working to move blood through your body). Scale Range 6-20.
Medical Research Council Scale of Breathlessness : The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). It can be self-administered by asking subjects to choose a phrase that best describes their condition, e.g. 'I only get breathless with strenuous exertion' (Grade 1) or 'I am too breathless to leave the house' (Grade 5).
Secondary Outcome Measures
Peak Expiratory Flow Rates (PEFR)
Peak expiratory flow rates, 80 to 100 percent of persons usual or "normal" peak flow rate signals all clear. 50 to 80 percent of persons or "normal" peak flow rate signals caution, Less than 50 percent of your usual or "normal" peak flow rate signals Medical alert.
Full Information
NCT ID
NCT04076085
First Posted
May 26, 2019
Last Updated
August 7, 2020
Sponsor
King Khalid University
Collaborators
Aseer Central Hospital, Khamis Mushayt General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04076085
Brief Title
Effect of Extremity Exercise in COPD
Official Title
Effect of Unsupported Upper Extremity Exercise Versus Lower Extremity Exercise in Individuals With Chronic Obstructive Disease (COPD) on Dyspnea and Peak Flow Rate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
April 27, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Khalid University
Collaborators
Aseer Central Hospital, Khamis Mushayt General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objective: is to find out the effect of unsupported upper extremity exercise versus lower extremity exercise on dyspnea and lung function
Methodology:
Sample and design: 60 patients with Randomized study design will be included in three groups.
Duration of intervention: Treatment will continue for 4 weeks. Outcome: Borgs scale and Medical Research Council scale (MRC) for dyspnea will be used to quantify the dyspnea. Lung function tests measure by PEFR, chronic obstructive pulmonary disease assessment test (CAT) will be used pre-post.
Discussion: We will compare three groups (UPPER EXTREMITY EXCERCISE (UEx), LOWER EXTREMITY EXERCISE (LEx), CONTROL (CON)) with COPD using interventional exercises for upper and lower extremities randomly assigned to three groups on the dyspnea symptoms and quantify and grade them pre-post the intervention. We will also use the CAT questionnaire pre-post to measure the changes in symptoms and functions.
Detailed Description
Background: Chronic Obstructive Pulmonary Disease (COPD) is one of the most common respiratory disorder affecting middle age group with progressing of symptoms worsening over time. The respiratory symptoms are persistent with compromised airflow due to small airway disorders or parenchymal abnormalities. The morbidity rate of COPD is about 251 million cases and mortality of 3.17 million per year globally with expected inflation in the future. The disease and death rate are well associated with dysfunction of skeletal muscle and cachexia. The amount of reduction in muscle strength of limbs is directly proportional to the severity of the disease. Dyspnea and decrement in endurance capacity will negatively affect the functional capability and quality of life in people suffering from COPD. Unsupported upper limb endurance training and lower limb endurance training showed significant improvement in Six-minute walk test and Quality of life.
Purpose: To determine the effect of Unsupported upper extremity endurance training and Unsupported lower extremity endurance training on dyspnea, lung function and quality of life.
Methodology: Study design: Randomized study design Study population: The people suffering from COPD referred by pulmonologist will be contacted for consent after oral explanation and answering all questions. After all the informed consents had been collected, randomization will be performed. The participants are randomly allocated to the Unsupported upper extremity endurance training (Experimental group-1), Unsupported lower extremity endurance training (Experimental group-2) and Conventional (Control group) prior to the first baseline assessment. The intensity of Exercise will be checked by the Original Borgs scale and Medical Research Council scale (MRC) for dyspnea.
Outcome measures: Lung function tests measures using PEFR, Airway Questionnaire 20 pre-post to measure the changes in symptoms and functions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Following randomization, subjects will be assigned either to receive Intervention OR CONTROL (Standard Care) throughout the entire study period (parallel design)
Masking
Outcomes Assessor
Masking Description
An employee outside the research team will feed data into the computer in separate datasheets so that the researchers can analyze data without having access to information about the allocation
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unsupported Upper extremity exercise
Arm Type
Active Comparator
Arm Description
Specially designed unsupported Arm exercises will be done for the population with a rating of somewhat hard 13-14 (Original scale) will be used as a guideline for intensity
Arm Title
Lower extremity exercise
Arm Type
Active Comparator
Arm Description
Specially designed Lower extremity exercises will be done for the population with a rating of somewhat hard 13-14 (Original scale) will be used as a guideline for intensity
Arm Title
Control
Arm Type
No Intervention
Arm Description
Here no active intervention will be given only standard care as prescribed by the hospital will be given
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Stretching exercise for warmup, All arm exercise with and without weights as tolerated by the patients. Similarly lower limb exercise in different positions like lying standing as tolerated by the patients
Primary Outcome Measure Information:
Title
Airway Questionnaire 20
Description
The Airway Questionnaire 20 (AQ20) was developed for patients with asthma and chronic obstructive pulmonary disease (COPD). It contains 20 items, with scores ranging from 0 to 20 - high scores indicate poor QOL. It takes only a few minutes to complete and has been validated in asthma and COPD patients.
Time Frame
Change is being evaluated from Baseline and at 4 wk
Title
Borg's scale and Medical Research Council scale (MRC) for dyspnea
Description
The Borg Rating of Perceived Exertion (RPE) scale will help you estimate how hard you're working (your activity intensity). Perceived exertion is how hard you think your body is exercising. Ratings on this scale are related to heart rate (how hard your heart is working to move blood through your body). Scale Range 6-20.
Medical Research Council Scale of Breathlessness : The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). It can be self-administered by asking subjects to choose a phrase that best describes their condition, e.g. 'I only get breathless with strenuous exertion' (Grade 1) or 'I am too breathless to leave the house' (Grade 5).
Time Frame
Change is being evaluated from Baseline and at 4 wk
Secondary Outcome Measure Information:
Title
Peak Expiratory Flow Rates (PEFR)
Description
Peak expiratory flow rates, 80 to 100 percent of persons usual or "normal" peak flow rate signals all clear. 50 to 80 percent of persons or "normal" peak flow rate signals caution, Less than 50 percent of your usual or "normal" peak flow rate signals Medical alert.
Time Frame
Change is being evaluated from Baseline and at 4 wk
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed cases of COPD
COPD secondary to any disease
Age 10-70 years
COPD in any stage according to GOLD classification
Exclusion Criteria:
Taking any other form of alternative therapies
The neurological deficit with the inability to understand of following instructions
Recent Cardiovascular surgery patients
Unstable angina patients
Patients with musculoskeletal deficits
Facility Information:
Facility Name
Snehil Dixit
City
Abha
State/Province
Aseer
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
As we don't directly control the data. The data privacy is subjected to countries law and regulations
Learn more about this trial
Effect of Extremity Exercise in COPD
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