Effect of Extremity Exercise in COPD

NCT04076085 | Unknown DMC

• 1 other identifier: ECM#2019-27
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Peak Expiratory Flow Rates (PEFR)

  Change is being evaluated from Baseline and at 4 wk

Study Arms (3)

Unsupported Upper extremity exercise

ACTIVE COMPARATOR

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

Lower extremity exercise

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

exercise 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; Unsupported Upper extremity exercise

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed cases of COPD
• COPD secondary to any disease
• Age 10-70 years
• COPD in any stage according to GOLD classification

You may not qualify if:

• 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

Sponsors & Collaborators

• King Khalid University: lead
• Aseer Central Hospital: collaborator
• Khamis Mushayt General Hospital: collaborator

Study Sites (1)

Snehil Dixit

Abhā, 'Asir Region, Saudi Arabia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor , Department of Medical Rehabilitation

Model Details: Following randomization, subjects will be assigned either to receive Intervention OR CONTROL (Standard Care) throughout the entire study period (parallel design)

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: September 3, 2019
• Study Start: September 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: April 27, 2021
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)