D Vitamine and Whole Body Vibration in Functional Outcomes

D Vitamine Supplementation and Whole Body Vibration Altering Functional Outcomes

Older with Chronic obstructive Pulmonary Disease (COPD) were submitted to chronic whole body vibration training during 03 months, receiving a vitamine D dose for each week or placebo vitamine. This group was compared with healthy older which were submitted to the same intervention.

Study Overview

• Status: Unknown
• Conditions: Aging; COPD
• Intervention / Treatment: Dietary supplement: Vitamine D supplementation; Other: chronic exercise in whole body vibration (WBV)

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50670-901
      • Federal University of Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Older patients with COPD
• Both genders
• Sedentary according to International Physical Activity Questionnaire (IPAQ) short form
• BMI in between 22.9 and 28 kg/m2.
• Older patients with COPD should have a clinical-functional diagnosis of the disease according to GOLD (GOLD, 2018), have been ex-smokers and have not used corticosteroids or have used this drug in a stable way for at least one year (without dosage or medication modifications).
• Older volunteers should be self-referenced healthy or, if they had systemic arterial hypertension or diabetes mellitus, these comorbidities should be controlled by diet or regular medication use.

Exclusion Criteria:

• Older patients with COPD who had episodes of exacerbation in the last three months, those with pulmonary rehabilitation programs in the last year, those who used home oxygen therapy, and patients with COPD-associated comorbidities were excluded.
• Volunteers of both groups who were taking vitamin D were excluded, as well as the current smokers, although occasional, volunteers with a history of labyrinthitis or thromboembolism, who had undergone surgical procedures of any size in the last year, such as plaques, pins or cardiac pacemakers, those with unconsolidated fractures that used medications that affected bone metabolism or lean mass, or those who had difficulties adapting to the assessment or the training protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: D vitamine; a dose for week	Dietary supplement: Vitamine D supplementation; a vitamine D dose for week; Other: chronic exercise in whole body vibration (WBV); exercise in WBV during 03 months, e times per week
Placebo Comparator: D vitamine placebo; a dose for week	Other: chronic exercise in whole body vibration (WBV); exercise in WBV during 03 months, e times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Change in walk distance achieved in metres, measured during the six minute walk test	before and immediately up to 12 weeks in WBV training.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance static and dynamic	Change in total scores of Tinetti index, composed by 16 items divided into 2 sections: static balance (9 items) with 16 points and gait or dynamic balance (7 items) with 12 points, summed in a total score of 28 points. Individuals scoring < 26 points have a risk for falling.	before and immediately up to 12 weeks in WBV training.
Gait speed	Change in time in seconds registered in Timed Up and Go test	before and immediately up to 12 weeks in WBV training.
Body composition	Change in electrical bioimpedance measuring the fat mass and lean mass in kilograms each one, in total body	before and immediately up to 12 weeks in WBV training.
Quality of life measure by WHOQOL	Change in total value obtained from WHOQOL-old questionnaire (World Health Organization of Quality Of Life) that evaluate in older the domains: sensory abilities; autonomy; past, present and future activities; social participation; death & dying; and intimacy. The Quality of life needs to improve when it is 1 to 2,9; is regular 3 to 3.9 points; good between 4 up to 4.9 and very good with 5 points.	before and immediately up to 12 weeks in WBV training.
Peripheral strength	Change in mean value obtained from 03 maneuvers of isokinetic contraction in a hand dynamometer (device that measure strength in handgrip), measured in centimeters of water.	before and immediately up to 12 weeks in WBV training.
Respiratory strength	Change in major value obtained after 03 maneuvers in manovacuometer (device that measure manometry for expiratory pressure and vacuum generated for the inspiratory pressure), all in centimeters of water.	before and immediately up to 12 weeks in WBV training.

Collaborators and Investigators

• Sponsor: Maíra F Pessoa

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): August 30, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: COPDinfl

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No