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Effects of Vitamin D Supplementation in Muscle Strength and Balance Training

Primary Purpose

Osteoporosis, Osteopenia, Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical exercise + Vitamin D3
Physical exercise
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis, Osteopenia focused on measuring Supplementary Feeding, vitamin D, Muscle Strength, postural balance, exercise, aged

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Julia Maria DÀndrea Greve

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Postural balance - dynamic - change
Evaluation of dynamic postural balance - The postural balance assessment (posturography) will be perform on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, OR, USA). The variables will be the mean sway speed (cm/s) on a stable surface and an unstable surface; and the mean sway in the anteropoterior direction and mediolateral (cm) direction at the same conditions. The variables will be the mean weight transfer index (%), mean movement time (s) and mean impact index.
Muscular strength - Hand Grip - change
Evaluation of muscular strength improvement- hand grip strength (HGS). HGS assessment was performed using a Jamar hand dynamometer, measured in kilograms (kg), which is adopted by the American Society of Hand Therapists (ASHT).
Muscular strength - Isokinetic dynamometry - change
Evaluation of muscular strength improvement - Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used were maximum peak torque corrected for body weight (%), and total work (J).
Muscular strength - 1 maximal repetition (RM)- change
Evaluation of muscular strength improvement - 1RM test. One-repetition maximum in weight training is the maximum amount of force that can be generated in one maximal contraction (kg).
Body composition and bone mineral density - change
Evaluation of body composition (area=cm2; BMC=g and BMD=g/cm2) and bone mineral density (BMD=g/cm2; T-score)

Full Information

First Posted
December 4, 2017
Last Updated
April 22, 2020
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03367585
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
April 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia, Osteoporosis, Postmenopausal
Keywords
Supplementary Feeding, vitamin D, Muscle Strength, postural balance, exercise, aged

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective clinical trial, double-blind, placebo-controlled intervention
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group, which will supplement vitamin D3 50,000 IU / week, being in two capsules (25,000 IU / week each),
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group will inject two capsules of equal size, volume and coloration, composed of lactose, without the vitamin D3 supplement.
Intervention Type
Dietary Supplement
Intervention Name(s)
Physical exercise + Vitamin D3
Intervention Description
Strength exercise + Supplementation of vitamin D3 50,000 IU / week
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
Strength exercise
Primary Outcome Measure Information:
Title
Postural balance - semi static - change
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Postural balance - dynamic - change
Description
Evaluation of dynamic postural balance - The postural balance assessment (posturography) will be perform on the NeuroCom Balance Master® force platform system (NeuroCom International, Inc., Clackamas, OR, USA). The variables will be the mean sway speed (cm/s) on a stable surface and an unstable surface; and the mean sway in the anteropoterior direction and mediolateral (cm) direction at the same conditions. The variables will be the mean weight transfer index (%), mean movement time (s) and mean impact index.
Time Frame
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).
Title
Muscular strength - Hand Grip - change
Description
Evaluation of muscular strength improvement- hand grip strength (HGS). HGS assessment was performed using a Jamar hand dynamometer, measured in kilograms (kg), which is adopted by the American Society of Hand Therapists (ASHT).
Time Frame
This measure will be perform before and after the intervation (12 weeks strenght and potural balance exercise).
Title
Muscular strength - Isokinetic dynamometry - change
Description
Evaluation of muscular strength improvement - Isokinetic dynamometry will be use to determine knee extension and flexion strength using the Biodex Multi-Joint System 3 (Biodex MedicalTM, Shirley, NY, USA). The isokinetic variables used were maximum peak torque corrected for body weight (%), and total work (J).
Time Frame
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).
Title
Muscular strength - 1 maximal repetition (RM)- change
Description
Evaluation of muscular strength improvement - 1RM test. One-repetition maximum in weight training is the maximum amount of force that can be generated in one maximal contraction (kg).
Time Frame
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).
Title
Body composition and bone mineral density - change
Description
Evaluation of body composition (area=cm2; BMC=g and BMD=g/cm2) and bone mineral density (BMD=g/cm2; T-score)
Time Frame
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).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.
Facility Information:
Facility Name
Julia Maria DÀndrea Greve
City
São Paulo
ZIP/Postal Code
04503-010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Vitamin D Supplementation in Muscle Strength and Balance Training

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