The goal of this clinical trial is to learn if a traditional Chinese medicine formula called "Huangjing Yangji Formula," combined with elastic band resistance training, works better than exercise alone to improve physical function and muscle strength in older adults with sarcopenia (age-related muscle loss). The main questions it aims to answer are:
Does the combined treatment improve participants' overall physical performance scores more than exercise with a placebo?
Does it lead to better outcomes in walking speed, balance, muscle strength, body composition, nutrition, mood, sleep, and overall quality of life?
Researchers will compare two groups. One group will take the real Huangjing Yangji Formula granules and do the standardized elastic band resistance training. The other group will take placebo granules (a look-alike mixture with no active medicine) and do the same training.
Participants will:
Take the assigned granules twice daily for 3 months.
Complete a standardized elastic band exercise program 3 times per week for 3 months (with both group and home sessions).
Attend three assessment visits (at the start, after 3 months, and 1 month after treatment) for tests and questionnaires.
Provide blood samples at the start and after 3 months for routine safety tests and special muscle health markers.
Aged between 50 and 75 years.
Willing and able to provide written informed consent personally or via a legal guardian.
Secondary sarcopenia due to specific diseases (e.g., active malignancy, hyperthyroidism, severe hepatic or renal dysfunction).
Presence of severe or uncontrolled cardiovascular disease, consumptive diseases (e.g., cancer), active infections, or severe osteoporosis.
Diagnosis of Alzheimer's disease, psychiatric disorders, or other cognitive/mental impairments that would hinder cooperation with the trial procedures.
Inability to perform activities of daily living or walk independently; or presence of motor dysfunction due to joint deformities, prolonged bed rest, fractures, or other reasons that would preclude safe participation in resistance training.
Parallel
Huangjing Yangji Formula Granules
DrugInvestigational herbal granule formulation. Each daily dose contains: Polygonati rhizoma (Huangjing) 15g, Codonopsis radix (Dangshen) 10g, Rehmanniae radix praeparata (Shudi) 9g, Angelica sinensis radix (Danggui) 6g, Cistanches herba (Roucongrong) 9g, Lycii fructus (Gouqi) 12g, Poria (Fuling) 9g, and Crataegi fructus (Shanzha) 6g. Administered orally as granules dissolved in water, twice daily (30 minutes after meals), for a period of 3 months.
Placebo Granules for Huangjing Yangji Formula
DrugMatched placebo granules. This preparation is specifically designed to be indistinguishable from the active "Huangjing Yangji Formula Granules" in terms of appearance, color, odor, packaging, and solubility. It contains no pharmacologically active herbal components. Administered orally in the same manner (twice daily, 30 minutes after meals) for 3 months.
Standardized Elastic Band Resistance Training Program
BehavioralA structured, progressive resistance training program using elastic bands. Participants train 3 times per week for 3 months. Each 60-minute session includes warm-up, 10 core strength exercises (e.g., standing row, leg extension, bridge), and cool-down. Intensity is progressively increased from low (approximately 40-60% of 1-RM) to medium-high (approximately 60-80% of 1-RM) resistance. Sessions are supervised once weekly, with twice-weekly home-based sessions.
Short Physical Performance Battery (SPPB) Score
The SPPB is a composite score ranging from 0 to 12 that assesses lower extremity physical function. It combines three tests: standing balance, 4-meter walking speed, and time to complete five chair stands. Scores are interpreted as: 0-3 (severe limitation), 4-6 (mild limitation), 7-9 (normal function), and 10-12 (excellent function). A higher score indicates better physical performance.
4-Meter Walking Speed
Usual walking speed (in meters per second) assessed over a 4-meter course. Participants are instructed to walk at their normal, comfortable pace. The average speed of two trials is calculated and used for analysis. This is a key measure of mobility and functional capacity.
Timed Up and Go Test (TUG)
Time (in seconds) required to stand up from a standard armchair, walk 3 meters at a usual pace, turn around, walk back, and sit down again. The test is performed twice, and the shorter time of the two trials is recorded. It is a widely used measure of functional mobility and fall risk.
Handgrip Strength
Maximal isometric strength of the dominant hand, measured in kilograms (kg) using a handheld dynamometer (handgrip). The participant is seated with the forearm supported. Three trials are performed, and the highest value is recorded as the outcome. It is a standard measure of overall muscle strength.
Tinetti Performance-Oriented Mobility Assessment (POMA)
Total score on the POMA, a standardized tool to assess balance and walking ability. It consists of a Balance subscale (9 items, score 0-16) and a Gait subscale (7 items, score 0-12). The total score ranges from 0 to 28, with a higher score indicating better mobility and lower fall risk. Scores are interpreted as: ≤18 (high fall risk), 19-24 (moderate fall risk), ≥25 (low fall risk).
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Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead sponsor
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Collaborator
Hunan University of Traditional Chinese Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
