Effect of Extremity Exercise in COPD

NCT ID: NCT04076085

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-04-27

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

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

exercise

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

exercise

Intervention Type: OTHER

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

Control

Here no active intervention will be given only standard care as prescribed by the hospital will be given

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aseer Central Hospital

OTHER_GOV

Sponsor Role: collaborator

Khamis Mushayt General Hospital

OTHER_GOV

Sponsor Role: collaborator

King Khalid University

OTHER

Sponsor Role: lead

Responsible Party

Snehil Dixit

Assistant Professor , Department of Medical Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Snehil Dixit

Abhā, 'Asir Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

ECM#2019-27

Identifier Type: -

Identifier Source: org_study_id