Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 90 day re-hospitalization rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40 - 80 years
- •Stable weight (<10 lbs change in past 12 months - self reported)
- •(Willing to) participate in pulmonary rehabilitation (PR) program at UTMB
- •Air flow limitation based on spirometry (FEV1 < 60% predicted) (prior to PR)
- •Daily symptoms according to COPD assessment test (CAT) > 15 (prior to PR)
排除标准
- •Late stage COPD, GOLD Stage 3-4 (FEV1 > 60% predicted)
- •Inability to perform 6-minute walking test or other physical therapy activities
- •Inability/unwillingness to follow the pulmonary rehabilitation program
- •Already more than 2 weeks into the pulmonary rehabilitation program at time of consenting
- •Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes)
- •Uncontrolled hypertension. Systolic blood pressure greater than or equal to 160mm Hg or a diastolic blood Pressure greater than or equal to 100mm Hg on three consecutive measurements taken at one-week intervals. Testosterone can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria
- •History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months
- •LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL cholesterol levels
- •Hematocrit greater than 51%
- •Current use of or history of recent anabolic steroid use (within 3 months)
- •Current abuse of alcohol or recreational drugs
- •Any other condition or event considered exclusionary by the PIs and covering faculty physician
- •Vulnerable populations including: individuals unable to consent on their own behalf, prisoners and pregnant women
研究组 & 干预措施
Placebo
Placebo (saline) injections will be given via intramuscular injection at study weeks 2,3, 6, 7, 10, and 11.
干预措施: Placebo (Drug)
Testosterone Enanthate
Testosterone Enanthate (100mg men, 25mg women) will be given via intramuscular injection at study weeks 2, 3, 6, 7, 10 and 11.
干预措施: Testosterone Enanthate (Drug)
结局指标
主要结局
90 day re-hospitalization rate
时间窗: 90 days
Re-hospitalization rates will be collected from the electronic medical record and/or subject interviews.
Exercise Capacity as measured by distanced walked during 6 minute walk test at baseline study testing
时间窗: baseline
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.
Exercise Capacity as measured by distanced walked during 6 minute walk test at 12 weeks.
时间窗: 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.
次要结局
- Lung Function as measured by Forced Vital Capacity (FVC) at 12 weeks.(12 weeks)
- Lung Function as measured by Maximal Voluntary Ventilation (MVV)at 12 weeks.(12 weeks)
- Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at baseline(baseline)
- Lung function as measured by Forced Expiratory Volume (FEV1) at baseline study testing(baseline)
- Lung Function as measured by Vital Capacity (VC) at 12 weeks(12 weeks)
- Handgrip strength as measured by hand dyanometer at baseline study testing(baseline)
- Lung Function as measured by Vital Capacity (VC) at baseline(baseline)
- Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at baseline.(baseline)
- Quality of Life as measured by COPD Assessment Test (CAT) at 12 weeks(12 weeks)
- Total serum testosterone at 12 weeks(12 weeks)
- Handgrip strength as measured by hand dyanometer at 12 weeks(12 weeks)
- Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at 12 weeks(12 weeks)
- Lung function as measured by Forced Expiratory Volume (FEV1) at 12 weeks(12 weeks)
- Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at 12 weeks.(12 weeks)
- Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at 12 weeks(12 weeks)
- Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at baseline.(baseline)
- Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at baseline.(baseline)
- Lung Function as measured by Forced Vital Capacity (FVC) at baseline(baseline)
- Lung Function as measured by Maximal Voluntary Ventilation (MVV)at baseline.(baseline)
- Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at baseline study testing.(baseline)
- Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at 12 weeks.(12 weeks)
- Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at 12 weeks.(12 weeks)
- Quality of Life as measured by COPD Assessment Test (CAT) at baseline study testing(baseline)
- Total serum testosterone at baseline(baseline)