Clinical trial NCT04076085: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: King Khalid University
Sponsor class: OTHER
Collaborators: name: Aseer Central Hospital
name: Khamis Mushayt General Hospital
First posted: 2019-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following randomization, subjects will be assigned either to receive Intervention OR CONTROL (Standard Care) throughout the entire study period (parallel design)
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Airway Questionnaire 20
timeFrame: Change is being evaluated from Baseline and at 4 wk
measure: Borg's scale and Medical Research Council scale (MRC) for dyspnea
timeFrame: Change is being evaluated from Baseline and at 4 wk
Secondary outcomes:
measure: Peak Expiratory Flow Rates (PEFR)
timeFrame: Change is being evaluated from Baseline and at 4 wk
Other outcomes:
Locations:
city: Abha
country: Saudi Arabia
facility: Snehil Dixit
state: Aseer
Study officials:
References: