A Trial to Study the Effects of Pulmonary Rehabilitation Program on Exercise Capacity and Quality of Life in Patients With Severe Form of Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive; Rehabilitation
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This study is a randomized parallel group controlled trial which aims to study the effects of
      pulmonary rehabilitation intervention on exercise capacity and quality of life in patients
      with severe COPD as compared to standard medical care. The expected duration is one and a
      half years with effect from 1st July, 2015 and will include 80 patients, 40 in each arm.
    

Detailed description: 
      Chronic obstructive pulmonary disease ranks among the top five causes of unnatural deaths in
      India and its prevalence continues to increase. Widespread habit of smoking and the use of
      biomass fuels have led to such a high prevalence of COPD. The loss of physical capacity and
      the adverse psychosocial effects of the disorder contribute greatly to morbidity and
      mortality. Medicines have a limited role in improving the lung functions and physical
      capacity in patients with COPD. Pulmonary rehabilitation (PR) aims to return the patient with
      chronic obstructive pulmonary disease (COPD) to the highest level of independent functioning.
      This is achieved by providing individually tailored exercise training schedules, education
      and psychosocial support.

      Pulmonary Rehabilitation has been defined by the American and the European Thoracic Societies
      as "a comprehensive intervention based on a thorough patient assessment followed by patient
      tailored therapies that include, but are not limited to, exercise training, education, and
      behavior change, designed to improve the physical and psychological condition of people with
      chronic respiratory disease and to promote the long-term adherence to health-enhancing
      behaviors." COPD is now considered a multi-systemic disease with frequent co-morbidities and
      hence the optimal management of this complex group of patients requires integrated care
      principles, pulmonary rehabilitation being the core component.

      Patients with chronic obstructive pulmonary disease (COPD) often decrease their physical
      activity because exercise can worsen dyspnea. The progressive deconditioning associated with
      inactivity initiates a vicious cycle, with dyspnea becoming problematic at ever lower
      physical demands. Pulmonary rehabilitation aims to break the cycle. Benefits of pulmonary
      rehabilitation include decreased dyspnea, improved health-related quality of life, fewer days
      of hospitalization, and decreased health-care utilization.

      As yet, there are no controlled studies on the use and effectiveness of pulmonary
      rehabilitation in the Indian setting and the optimum training regimen. This study aims to
      look at any improvements in the exercise capacity by means of objective incremental and field
      exercise tests, quality of life using validated questionnaires, severity of dyspnea, lung
      functions and nutritional parameters in patients who are diagnosed with severe forms of COPD
      after they have undergone a structured exercise training program.

      Primary Objective • To assess the effect of structured outpatient pulmonary rehabilitation
      intervention on the six minute walk distance and health related quality of life in patients
      with chronic obstructive pulmonary disease.

      Secondary Objectives

      • To study the effects of pulmonary rehabilitation on:

        -  Maximum oxygen consumption (VO2max) and anaerobic threshold (AT)

        -  Lung functions: measured by changes in FEV1 and FVC

        -  Depression, Anxiety and Stress score (DASS)

        -  BODE (Body Mass Index, level of obstruction, level of dyspnea and exercise capacity)
           index

        -  Anthropometry: BMI and MUAC

      Study design: Randomized Controlled Study Selection of subjects: Patients who have been
      diagnosed as Chronic Obstructive Pulmonary Disease visiting the outpatient clinic of the
      department of Pulmonary Medicine and Sleep Disorders Inclusion criteria

        -  Patients with severe COPD based on spirometry (FEV1 below 50%) presenting to pulmonary
           medicine outpatient clinic with modified medical research council (mMRC) grade 1 to 3.

        -  Those who are willing to participate in the study Exclusion criteria

        -  Patients on long term oxygen therapy or candidates for long term oxygen therapy

        -  Patients with severe orthopedic or neurological disorders limiting their mobility

        -  Exercise induced syncope

        -  Unstable angina or recent MI (within 4 months)

        -  Diagnosed Cognitive or active psychiatric disorders

        -  Comorbidities: uncontrolled hypertension >180/100

        -  Recent hospitalization for exacerbation within 6 weeks Sample size and location: 80
           patients with diagnosed COPD presenting in the department of Pulmonary Medicine and
           Sleep Disorders, who will be randomized to 40 patients in each arm based on simple
           random sampling method.

      Study Period: January 2015 to November 2017 Follow Up period: 8 weeks METHODOLOGY I. BASELINE
      EVALUATION After initial screening on patients with COPD in terms of severity, feasibility
      and commitment, patients who fulfill the inclusion and exclusion criteria will be randomized
      using computer generated random numbers to intervention and control groups. A baseline chest
      xray postero-anterior view (CXR-PA) view and a 12-lead electrocardiogram will be available
      before enrollment in the study. All patients will undergo pulmonary function test (PFT),
      cardiopulmonary exercise test using incremental cycle ergometry protocol (CPET), and six
      minute walk test (6MWT), along with the baseline demographic history and other relevant
      clinical information. CPET and 6MWT will be performed on two separate days. The six minute
      walking distance, VO2max and maximum work output during cycling and Saint George Respiratory
      Questionnaire will be recorded. Other nutritional parameters (mid-upper arm circumference,
      skin fold thickness), Depression Anxiety Stress Score, dyspnea scale and body mass index
      (BMI) will also be calculated and recorded. The 6MWT will be performed in accordance with the
      instructions of the American Thoracic Society, verbal encouragement will be given and the
      distance recorded. All these will be repeated at the end of 8 weeks. Tests will be separated
      by a minimum of one hour or until heart rate and oxygen saturation return to resting values.

      II. RANDOMIZATION This will be done by using computer generated random numbers. III. EXERCISE
      TRAINING After the initial baseline evaluation, patients will be enrolled into the pulmonary
      rehabilitation program at the rehabilitation centre located in the premises of the department
      of pulmonary medicine and sleep disorders. The total duration of the program would be 12
      weeks, with thrice weekly sessions of exercise training of minimum one hour duration.
      Participants will complete a minimum of 10 minutes each of treadmill walking, cycling, upper
      and lower limb resistance exercises at the 4 separated exercise stations located in the
      rehabilitation clinic of the Department of Pulmonary Medicine and Sleep Disorders. Rest
      period will be provided as required during the first 3 sessions. Second week onwards,
      participants will be encouraged to perform continuous training with intensity targeted at
      more than 60% of the maximum workload or till borg dyspnea scale of 4 to 6 is reached, with
      maximum of 10 minutes of rest per session during which breathing retraining exercises will be
      performed. It will then be followed by structured upper and lower limb strength exercises
      (e.g. sit-to-stand, foot treadling, thigh strengthening). Strength training will commence by
      performing one set of 8-12 repetitions of the exercise and progressed by increasing the
      number of sets from one to three gradually, targeting BORG dyspnea and fatigue scale of 4 to
      6.

      Adherence with training will be defined as completion of at least 80% of training sessions.
      All patients will be encouraged to perform daily activities such as walking and stair
      climbing and structured upper and lower limb exercises at home. (Manual/handouts provided). A
      diary will be provided to each of them to maintain daily symptoms and exercises at home.
    

Intervention name(s): Pulmonary Rehabilitation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chronic Obstructive Pulmonary Disease; rehabiltation