Effect of Extremity Exercise in COPD

Effect of Unsupported Upper Extremity Exercise Versus Lower Extremity Exercise in Individuals With Chronic Obstructive Disease (COPD) on Dyspnea and Peak Flow Rate

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: exercise

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Aseer
    • Abha, Aseer, Saudi Arabia
      • Snehil Dixit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unsupported Upper extremity exercise; 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	Other: exercise; 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
Active Comparator: Lower extremity exercise; 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	Other: exercise; 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
No Intervention: Control; Here no active intervention will be given only standard care as prescribed by the hospital will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change is being evaluated from Baseline and at 4 wk
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).	Change is being evaluated from Baseline and at 4 wk

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change is being evaluated from Baseline and at 4 wk

Collaborators and Investigators

• Sponsor: King Khalid University
• Collaborators: Aseer Central Hospital; Khamis Mushayt General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): April 27, 2021

Study Registration Dates

• First Submitted: May 26, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ECM#2019-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As we don't directly control the data. The data privacy is subjected to countries law and regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No