Effects of Vitamin D Supplementation in Muscle Strength and Balance Training

NCT03367585 | Completed

• 1 other identifier: 306/15
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Osteopenia; Osteoporosis, Postmenopausal

Keywords

Supplementary Feeding; vitamin D; Muscle Strength; postural balance; exercise; aged

Outcome Measures

Primary Outcomes (1)

• Postural balance - semi static - change

  Evaluation of postural balance - AccSway force platform for semi static postural. The arithmetic mean of the results was calculated from the three tests conducted under each condition, and was processed using the Balance Clinic software. The following parameters were used to measure the stability of the participants: medial-lateral and anteroposterior amplitude (cm), the mean velocity calculated from the total displacement of the center of pressure (COP) in all directions (cm/s), and the elliptical area encompassing 95% of the displacement from the COP (cm2). The following parameters were used to measure the stability of the participants: medial-lateral and anteroposterior amplitude (cm), the mean velocity calculated from the total displacement of the center of pressure (COP) in all directions (cm/s).

  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 (5)

• Postural balance - dynamic - change

  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).

• Muscular strength - Hand Grip - change

  This measure will be perform before and after the intervation (12 weeks strenght and potural balance exercise).

• Muscular strength - Isokinetic dynamometry - change

  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).

• Muscular strength - 1 maximal repetition (RM)- change

  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).

• Body composition and bone mineral density - change

  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).

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group, which will supplement vitamin D3 50,000 IU / week, being in two capsules (25,000 IU / week each),

Dietary Supplement: Physical exercise + Vitamin D3

Placebo

PLACEBO COMPARATOR

The placebo group will inject two capsules of equal size, volume and coloration, composed of lactose, without the vitamin D3 supplement.

Other: Physical exercise

Interventions

Physical exercise + Vitamin D3 DIETARY_SUPPLEMENT

Strength exercise + Supplementation of vitamin D3 50,000 IU / week

Experimental

Physical exercise OTHER

Strength exercise

Placebo

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Julia Maria DÀndrea Greve

São Paulo, 04503-010, Brazil

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Motor Activity

Interventions

Exercise; Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized prospective clinical trial, double-blind, placebo-controlled intervention

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: February 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: April 22, 2020
• Last Updated: April 24, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)