Clinical trial NCT03367585: Effects of Vitamin D Supplementation in Muscle Strength and Balance Training
Official title: Effects of Vitamin D Supplementation in Muscle Strength and Postural Balance Training in Vulnerable Elderly Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Osteopenia
Osteoporosis, Postmenopausal
Keywords: Supplementary Feeding
vitamin D
Muscle Strength
postural balance
exercise
aged
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 46
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective clinical trial, double-blind, placebo-controlled intervention
Primary purpose: TREATMENT

Brief summary: Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting from falls. Vitamin D deficiency can cause muscular atrophy in type II fibers (fast contraction and strength), which can increase the risk of falls. The aging process produces reduction in the ability of postural control system to maintain postural balance, which may increase postural instability and consequently increase the elderly risk to falls. Objective: To evaluate if vitamin D supplementation associated with regular exercise in vulnerable older women improves muscle strength and postural balance in 12 weeks. Methods: This will be a randomized prospective clinical trial, double blind, placebo-controlled intervention. Will be part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will be coming from the community through calls made by radio and social network. The volunteer will undergoing to blood test, body composition and bone mineral density, Mini Mental State Examination, Geriatric Depressive Scale, Falls Efficacy Scale, WHOQOL-OLD and WHOQOL-BREF instruments, functional capacity tests (MiniBEST, Time up and Go, Chair Rising Test, Six-minute walk test), muscular strength assessment (isokinetic dynamometry, handgrip and 1RM test) and postural balance (AccSway force platform for static postural balance and NeuroCom's Balance Master for dynamic postural balance) before and after 12 weeks of intervention with vitamin D supplementation and resistance and postural balance exercise. The intervention that will be perform during the 12 weeks with a progressive resistance training program.


Eligibility criteria: Inclusion Criteria:

1. Age \> 60 years;
2. Osteoporosis or osteopenia (bone mineral density lower than -1.5 standard deviations of the T-score);
3. Present hypovitaminosis D (\<30 nmol / L);
4. Do not practice regular resistance exercise;
5. Can not have an injury in lower limbs at least on the last three months,;
6. Be able to perform independent gait without climbing for at least 100 meters;
7. Be independent in your daily life activities;
8. Do not present restrictions for the practice of resistance exercises, including having performed a recent exercise test (maximum 6 months);
9. Do not use medications such as estrogen's, diuretics, to improve bone mass;
10. Do not use dietary supplements with vitamin D;
11. Do not present hyperparathyroidism, diabetes, uncontrolled hypertension, hyperprolactinemia, hypercalciuria, renal lithiasis or elevated serum calcium.

Primary outcomes:
measure: Postural balance - semi static - change
timeFrame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Secondary outcomes:
measure: Postural balance - dynamic - change
timeFrame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
measure: Muscular strength - Hand Grip - change
timeFrame: This measure will be perform before and after the intervation (12 weeks strenght and potural balance exercise).
measure: Muscular strength - Isokinetic dynamometry - change
timeFrame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
measure: Muscular strength - 1 maximal repetition (RM)- change
timeFrame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
measure: Body composition and bone mineral density - change
timeFrame: This measure will be performing before; after the innervation (12 weeks strength and postural balance exercise) and six months after the intervention (six months follow up).
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Julia Maria DÀndrea Greve
Study officials:
References: