Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation of the airways and/or damage to the lungs which leads to progressive impairment in airflow and the ability to breathe. COPD affects 6 to 20% of the US population and is among the leading causes for mortality in men and women. While COPD is principally a pathology of the airway, skeletal muscle wasting is a widely recognized comorbidity contributing to frequent and expensive hospital visits. Hospital readmission rates among COPD patients are high and the majority of the readmissions are considered preventable. The reasons COPD patients lose muscle are still poorly understood although reduced pulmonary function has been associated with reduced testosterone levels. Muscle building treatments, including testosterone therapy, with and without exercise, have consistently been shown to promote improvements in body composition, exercise capacity, and health related quality of life of COPD patients. The overall goal of this investigation is to provide an effective long-term treatment strategy that prevents the advancement of COPD in men and women through a safe, cycled administration of testosterone during the early stages of disease.
Male and female COPD patients participating in a 12 week pulmonary rehabilitation program at the University of Texas Medical Branch enrolled in the study will be randomized into either placebo or testosterone enanthate (100mg men, 25mg women) treatment. Testosterone and placebo will be given in a cyclic fashion during the pulmonary rehabilitation with single injections given on weeks 2, 3, 6, 7, 10 and 11. Baseline (during week 1 of rehabilitation) and post (during week 12 of rehabilitation) study testing will measure the effectiveness of testosterone on several measures listed in the outcome section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Testosterone Enanthate (25 mg women, 100mg men) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.
Placebo Injection (saline) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.
University of Texas Medical Branch
Galveston, Texas, United States
90 day re-hospitalization rate
Re-hospitalization rates will be collected from the electronic medical record and/or subject interviews.
Time frame: 90 days
Exercise Capacity as measured by distanced walked during 6 minute walk test at baseline study testing
Exercise capacity will be measured by distance walked in 6 minutes on a predefined course. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 6 minutes. Distance traveled for the 6 minutes will be recorded. The walking test will be completed at baseline. Data will be reported as meters (m) walked in 6 minutes.
Time frame: baseline
Exercise Capacity as measured by distanced walked during 6 minute walk test at 12 weeks.
Exercise capacity will be measured by distance walked in 6 minutes on a predefined course. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 6 minutes. Distance traveled for the 6 minutes will be recorded. The walking test will be completed at baseline. Data will be reported as meters (m) walked in 6 minutes.
Time frame: 12 weeks
Handgrip strength as measured by hand dyanometer at baseline study testing
Handgrip strength as measured by hand dyanometer at baseline of pulmonary rehabilatation and study drug intervention. Data will be reported as maximum force produced in kilograms.
Time frame: baseline
Handgrip strength as measured by hand dyanometer at 12 weeks
Handgrip strength as measured by hand dyanometer after 12 weeks of pulmonary rehabilatation and study drug intervention. Data will be reported as maximum force produced in kilograms.
Time frame: 12 weeks
Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at baseline
The BDS assesses difficulty breathing during the 6 minute walk test. Patients indicate their level of difficulty on a scale of 0 (no difficult) to 10 (maximal difficulty).
Time frame: baseline
Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at 12 weeks
The BDS assesses difficulty breathing during the 6 minute walk test. Patients indicate their level of difficulty on a scale of 0 (no difficult) to 10 (maximal difficulty).
Time frame: 12 weeks
Lung function as measured by Forced Expiratory Volume (FEV1) at baseline study testing
Lung function as measured by Forced Expiratory Volume (FEV1). FEV1 measured the amount of air that can be forcefully exhaled in one second. FEV1 is measured using a standard spirometer. Data will be reported as L of air expelled.
Time frame: baseline
Lung function as measured by Forced Expiratory Volume (FEV1) at 12 weeks
Lung function as measured by Forced Expiratory Volume (FEV1). FEV1 measured the amount of air that can be forcefully exhaled in one second. FEV1 is measured using a standard spirometer. Data will be reported as L of air expelled.
Time frame: 12 weeks
Lung Function as measured by Vital Capacity (VC) at baseline
Lung function as measured by Vital Capacity (VC) at baseline. VC measures the maximum amount of air that can be exhaled from the lung. VC is measured using a standard spirometer. Data will be reported as L of air expelled.
Time frame: baseline
Lung Function as measured by Vital Capacity (VC) at 12 weeks
Lung function as measured by Vital Capacity (VC) at 12 weeks. VC measures the maximum amount of air that can be exhaled from the lung. VC is measured using a standard spirometer. Data will be reported as L of air expelled.
Time frame: 12 weeks
Lung Function as measured by Forced Vital Capacity (FVC) at baseline
Lung function as measured by Forced Vital Capacity (FVC) at baseline. FVC measures the maximum amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured using a standard spirometer. Data will be reported as L of air expelled.
Time frame: baseline
Lung Function as measured by Forced Vital Capacity (FVC) at 12 weeks.
Lung function as measured by Forced Vital Capacity (FVC) at baseline. FVC measures the maximum amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured using a standard spirometer. Data will be reported as L of air expelled.
Time frame: 12 weeks
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at baseline.
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at baseline. FEF 25-75 measures the flow (speed) of air coming out of the lung during the middle portion of the forced expiration. FEF 25-75 is measured using a standard spirometer. Data will be reported as L/second.
Time frame: baseline
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at 12 weeks.
Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at 12 weeks. FEF 25-75 measures the flow (speed) of air coming out of the lung during the middle portion of the forced expiration. FEF 25-75 is measured using a standard spirometer. Data will be reported as L/second.
Time frame: 12 weeks
Lung Function as measured by Maximal Voluntary Ventilation (MVV)at baseline.
Lung Function as measured by Maximal Voluntary Ventilation (MVV) at baseline. MVV measures the maximum volume of air that can be breathed in 15 seconds. MVV is measured using a standard spirometer. Data will be reported as L of air.
Time frame: baseline
Lung Function as measured by Maximal Voluntary Ventilation (MVV)at 12 weeks.
Lung Function as measured by Maximal Voluntary Ventilation (MVV) at 12 weeks. MVV measures the maximum volume of air that can be breathed in 15 seconds. MVV is measured using a standard spirometer. Data will be reported as L of air.
Time frame: 12 weeks
Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at baseline study testing.
Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue (range -24-96, with higher scores indicating more fatigue) and five subscales (general, physical, emotional, mental, vigor). With the exception of the vigor subscale, higher scores indicate greater fatigue.
Time frame: baseline
Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at 12 weeks
Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue (range -24-96, with higher scores indicating more fatigue) and five subscales (general, physical, emotional, mental, vigor). With the exception of the vigor subscale, higher scores indicate greater fatigue.
Time frame: 12 weeks
Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at baseline.
The St. George's Respiratory Questionnaire (SGRQ) measures the impact of the disease on overall health, daily life and perceived wellbeing in patients with obstructive airways disease. Scoring is calculated for three components (Symptoms, Activity and Impacts), these components are summed to create a total score. Total scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: baseline
Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at 12 weeks.
The St. George's Respiratory Questionnaire (SGRQ) measures the impact of the disease on overall health, daily life and perceived wellbeing in patients with obstructive airways disease. Scoring is calculated for three components (Symptoms, Activity and Impacts), these components are summed to create a total score. Total scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: 12 weeks
Quality of Life as measured by COPD Assessment Test (CAT) at baseline study testing
The COPD Assessment Test (CAT) is an 8-item questionnaire measuring the impact of COPD on wellbeing and daily life. Each question is rated from 0 (lowest impact) to 5 (highest impact). Scores from each question are summed to calculate a total score. Total scores range from 0 to 40, with higher scores indicating higher impact from COPD. Classification of total score: 0-10 (low impact); 11-20 (medium impact); 21-30 (high impact); 31-40 (very high impact).
Time frame: baseline
Quality of Life as measured by COPD Assessment Test (CAT) at 12 weeks
The COPD Assessment Test (CAT) is an 8-item questionnaire measuring the impact of COPD on wellbeing and daily life. Each question is rated from 0 (lowest impact) to 5 (highest impact). Scores from each question are summed to calculate a total score. Total scores range from 0 to 40, with higher scores indicating higher impact from COPD. Classification of total score: 0-10 (low impact); 11-20 (medium impact); 21-30 (high impact); 31-40 (very high impact).
Time frame: 12 weeks
Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at baseline.
The Hospital Anxiety \& Depression Scale (HADS) is a 14-item questionnaire with 7 questions measuring anxiety and 7 questions measuring depression. Depression and anxiety will each have their own total score (0-21). Scores classifications: 0-7 (normal); 8-10 (mild); 11-14 (moderate); 15-21 (severe).
Time frame: baseline
Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at 12 weeks.
The Hospital Anxiety \& Depression Scale (HADS) is a 14-item questionnaire with 7 questions measuring anxiety and 7 questions measuring depression. Depression and anxiety will each have their own total score (0-21). Scores classifications: 0-7 (normal); 8-10 (mild); 11-14 (moderate); 15-21 (severe).
Time frame: 12 weeks
Total serum testosterone at baseline
Total serum testosterone will be measured at baseline by the UTMB Clinical Laboratory.
Time frame: baseline
Total serum testosterone at 12 weeks
Total serum testosterone will be measured at baseline by the UTMB Clinical Laboratory.
Time frame: 12 weeks
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