Evaluation of nandrolone decanoate treatment combined with physiotherapy and diet in elderly patients with sarcopenia

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What is this study about?

This study focuses on sarcopenia, a condition characterized by the loss of muscle mass and function that typically develops with age. This condition can lead to difficulties in performing daily activities, increased risk of falls, and reduced quality of life in older adults. The study will evaluate a treatment combining nandrolone decanoate (also known as Deca-Durabolin) with comprehensive physical therapy and dietary modifications.

The research aims to determine how effective nandrolone therapy is in treating sarcopenia when combined with exercise and diet. During the study, participants will receive either intramuscular injections of nandrolone or a placebo, along with physical therapy and dietary guidance. The treatment period will last for 12 months.

The study will measure improvements in physical fitness through walking tests and other physical performance measures. This research is particularly important for understanding how to better manage muscle loss in older adults and potentially improve their overall function and independence in daily activities.

Who Can Join the Study?

You must be between 60 and 99 years old.
You must have a diagnosis of sarcopenia, which is a condition where a person loses muscle mass and muscle strength.
You must show signs of muscle weakness, which is measured by one of two ways: having low strength when squeezing a hand-held device called a hand dynamometer (less than 27 kg for men and 16 kg for women), or having difficulty performing a chair rise test (taking longer than 15 seconds to stand up from a chair 5 times).
You must have a reduction in muscle mass, which is measured by one of the following: a low muscle density measurement, having a total muscle mass in the arms and legs that is less than 20 kg for men or less than 15 kg for women, or having a low amount of skeletal muscle mass (the muscles used for movement) as shown by a bioelectrical impedance (BIA) test, which is a medical scan that uses a small electrical current to estimate body composition.

Who Cannot Join the Study?

A score of less than 19 on the Mini-Mental State Examination, which is a test used to measure mental sharpness and memory.
Having nephrotic syndrome (a kidney disorder that causes the body to pass too much protein in the urine) or glomerulonephritis (inflammation of the tiny filters in the kidneys).
Having advanced circulatory failure, specifically stages III or IV of the NYHA scale, which describes how much heart problems limit your physical activity.
Having acute or chronic respiratory failure, which means your lungs are not providing enough oxygen to the body, requiring the use of oxygen therapy.
Having specific muscle or nerve diseases, such as Amyotrophic lateral sclerosis (a disease that affects nerve cells in the brain and spinal cord), multiple sclerosis (a disease affecting the central nervous system), myasthenia gravis (a condition that causes weakness in muscles), dystrophies (muscle wasting diseases), spinal muscular atrophy, or other myopathies (diseases that affect muscle tissue).
Having epilepsy (a condition that causes recurring seizures).
The need for certain medications during the study, including systemic corticosteroids (strong anti-inflammatory drugs) used for more than 3 weeks, hormone replacement therapy, 5-alpha reductase inhibitors, aromatase inhibitors, other hormonal drugs with muscle-building effects, or megestrol.
The inability to provide informed consent, which is the official agreement to participate in the study after understanding all the details.
Having a malignant tumor (cancer) or blood-related diseases like leukemia, lymphoma, or myeloproliferative diseases that require cancer treatment, specifically if it has been less than 5 years since certain cancers (like prostate or kidney cancer) or less than 12 months since other cancers were treated.
Having suspected or diagnosed prostate or breast cancer in men.
Having inflammatory diseases of the gastrointestinal tract that cause malabsorption (when the body cannot properly soak up nutrients from food), such as celiac disease, ulcerative colitis, or Crohn’s disease.
Having uncompensated hyperthyroidism or hypothyroidism (conditions where the thyroid gland is either too active or not active enough, and the body is not managing the imbalance).
Having a recent myocardial infarction (heart attack) or stroke within the last 4 weeks.
Having a history of thromboembolism (blood clots that move through the bloodstream) within the last 6 months or having recurring blood clots.
Having a hypertensive crisis (a sudden, severe increase in blood pressure).
Having liver impairment, which is shown by high levels of liver enzymes known as AST and ALT in a blood test.
Having acute kidney injury or chronic kidney disease at advanced stages (stage G4 or G5).

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	15.02.2023

Trial locations

Investigated drugs:

Nandrolone decanoate is an injectable medication used to test its effectiveness in treating sarcopenia, which is the loss of muscle mass and strength. It is being studied to see if it can help improve muscle conditions.

Sarcopenia – This condition involves the progressive loss of muscle mass and strength. It typically develops as a person gets older. As it advances, it can lead to a decline in the ability to perform everyday physical tasks. The loss of muscle function may also affect overall physical stability.

Trial ID:

2024-517178-48-00

Protocol code:

NIGRIR_002SARKOPENIA

Trial Phase:

Therapeutic exploratory (Phase II)

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Evaluation of nandrolone decanoate treatment combined with physiotherapy and diet in elderly patients with sarcopenia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?