Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Patrocinadores

Patrocinador principal: Washington University School of Medicine

Colaborador: Solvay Pharmaceuticals

Fuente Washington University School of Medicine
Resumen breve

The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.

Descripción detallada

Decreases in physical abilities, including losses of strength, endurance, balance, and coordination are major causes of disability and loss of independence in older men. Such individuals are at high risk for injurious falls, hospitalization, and use of supportive services. Age-associated testosterone deficiency may contribute to deficits in muscle mass and strength that are common in this patient population.

The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve skeletal muscle mass and skeletal muscle strength, to a greater degree than six months of exercise training alone.

Secondary study aims are to determine in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve physical function, bone mineral density, and quality of life, to a greater degree than six months of exercise training alone.

Comparison: Men age 65 years and older who meet criteria for physical frailty and have a serum testosterone level below 350 ng/dl are randomly assigned to one of two groups: 1) transdermal testosterone replacement therapy + supervised exercise training for six months vs. 2) inactive placebo gel + supervised exercise training for six months.

Estado general Completed
Fecha de inicio November 2004
Fecha de Terminación August 2009
Fecha de finalización primaria February 2009
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Mean Change in Total Lean Body Mass Baseline and Six Months
Change in Skeletal Muscle Strength by 1-RM Baseline and Six Months
Resultado secundario
Medida Periodo de tiempo
Change in Isokinetic Leg Extension Torque at 0 Deg/Sec Baseline and Six Months
Change in Leg Extension Torque at 60 Deg/Sec Baseline and Six Months
Change in Total Body Fat Mass Baseline and Six Months
Change in Femoral Bone Mineral Density (BMD) Baseline and Six Months
Change in Total Modified Physical Performance (mPPT) Score Baseline and Six Months
Change in Serum Testosterone Level Baseline and Six Months
Inscripción 25
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Transdermal Testosterone gel (1%)

Descripción: Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl.

Etiqueta de grupo de brazo: Transdermal Testosterone gel (1%)

Otro nombre: Androgel

Tipo de intervención: Behavioral

Nombre de intervención: Supervised exercise training

Descripción: Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.

Elegibilidad

Criterios:

Inclusion Criteria:

- Male, age 65 years and older

- Total serum testosterone level < 350 ng/dl

- Total Modified Physical Performance Test Score <28

Exclusion Criteria:

- Inability to walk 50 feet independently

- Current use of estrogen, progestin, or androgen containing compound

- Diagnosis of dementia of severity sufficient to interfere with informed consent or compliance with the protocol, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration

- Visual or hearing impairments that interfere with following directions

- Cardiopulmonary disease (recent MI, unstable angina or CHF, etc.), neuromuscular impairments, or unstable medical condition that would contraindicate progressive resistance exercise training

- History of prostate cancer or hormone dependent neoplasia

- PSA level > 4 ng/ml

- Serum liver transaminase levels of greater than 2 standard deviations above normal

- Use of drugs for osteoporosis for less than 1 year

- Current participation in a vigorous exercise or weight-training program more than once per week

- History of sleep apnea requiring use of CPAP

- Uncontrolled thyroid disease

- Diagnosis of cancer within the past 5 years other than superficial skin cancer (squamous or basal cell)

- hematocrit > 50%

- AUA symptom score > 16.

- History of alcohol or substance abuse

- Presence of severe facial acne

- Active symptoms of depression with GDS score > 5 and symptoms severe enough to cause >5% weight loss in previous 3 months or interfere with research assessments

Género: Male

Edad mínima: 65 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Ellen F. Binder, MD Principal Investigator Washington University School of Medicine
Ubicación
Instalaciones: Washington University School of Medicine
Ubicacion Paises

United States

Fecha de verificación

January 2018

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Washington University School of Medicine

Nombre completo del investigador: Ellen F. Binder, MD

Título del investigador: Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Transdermal Testosterone gel (1%)

Tipo: Active Comparator

Descripción: Transdermal testosterone 1% gel (Androgel) provided as 2.5 gm and/or 5 gm gel packets with dose titration and monthly dose adjustments to achieve and maintain serum total testosterone level between 500-900 mg/dL. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.

Etiqueta: Placebo gel

Tipo: Placebo Comparator

Descripción: Inactive topical gel identical in appearance to the active medication, provided in packets identical to the packaging for the active medication. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov