Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet

PHASE2RecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

August 10, 2023

Primary Completion Date

June 12, 2026

Study Completion Date

October 30, 2026

Conditions
Sarcopenia
Interventions
DRUG

Nandrolone Decanoate

Patients will receive nandrolone decanoate (1 ml, 50 mg/ml intramuscularly given per visit) or placebo

BEHAVIORAL

Physiotherapy Intervention

"The physiotherapeutic intervention includes the following components:~1. Strength training will include strength exercises 3 x a week x 30 min - load from 60% to 80% 1RM for individual muscle groups, - 10 repetitions of the exercise, - 1-3 series in 1 session (break between sessions 60 seconds).~2. Endurance training will include aerobic exercises (cycle ergometer, treadmill, general fitness exercises) 3 times a week x 30 minutes, load from 60% to 80% of maximum heart rate."

BEHAVIORAL

Nutritional Intervention

An individual diet in terms of calorific value and the content of energy substrates - proteins, fats and carbohydrates, as well as other nutrients, in accordance with specific nutrition standards.

DRUG

Placebo

Placebo

Trial Locations (1)

02-637

RECRUITING

Centrum Wsparcia Badań Klinicznych, Warsaw

Sponsors
All Listed Sponsors
collaborator

Medical Research Agency, Poland

OTHER_GOV

lead

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

NETWORK

NCT05978206 - Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet | Biotech Hunter | Biotech Hunter