Muscle Weakness
Conditions
Keywords
Alfacalcidol, Falls, Handgrip, Muscle strength, Sarcopenia
Brief summary
The age-related increase in falls is strongly associated with a decline in muscle strength by the mechanism of sarcopenia. There has been great interest in developing approaches to counteract the effects of sarcopenia, and thereby reduce the age-related decline in muscle mass with vitamin D that have muscular effect. However, a limited number of studies demonstrate a vitamin D analog (alfacalcidol) increase in lower body muscle strength in adults with vitamin D deficiency. A double-blinded randomized controlled trial was conducted in order to determine the effect of alfacalcidol on the upper-body muscle strength in Indonesian elderly women in age group of 60 or more who had low handgrip strength.
Detailed description
A total 122 elderly women were enrolled to this study. It was determined subjects with handgrip strength less than 22 kg and measured using handheld dynamometer. There were 95 subjects fulfilled the eligible criteria. These subjects were randomized into two groups, one group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo. Each subject was given calcium 500 mg/day. After 12 weeks of intervention, 88 subjects had the second muscle strength measurement (7 dropped out).
Interventions
DRUGalfacalcidol
One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Elderly women in age group of 60 or more * Subjects with handgrip strength less than or equal to 22 kg
Exclusion criteria
* Hypercalcemia (serum calcium \> 10.5 mg / dL) * Can not understand instructions well (MMSE scale \< 16) * Depression (Geriatric Depression Scale\> 10) * Fracture, deformity, and pain with a visual analog scale (VAS) ≥ 4 on fingers and joints of the upper limb when the examination will be conducted * Heart failure fc. III-IV or uncontrolled according to the New York Heart Association (NYHA) * Neurological conditions (epilepsy, acute stroke, Parkinson's) * Malignant hypertension (systolic blood pressure ≥ 200 mmHg and or diastolic blood pressure ≥ 120 mmHg) * Blood malignancies and solid tumors * Decreased function of the liver (cirrhosis, ALT increase above 2 times the upper normal limit ) * Refusing to follow the research / not willing controls
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of muscle strength in the group that received alfacalcidol compared to placebo | 12 weeks | After 12 weeks of intervention, 88 subjects had the second muscle strength measurement |
Countries
Indonesia
Outcome results
None listed