D Vitamine and Whole Body Vibration in Functional Outcomes

Not Applicable

• Conditions: Aging; COPD
• Interventions: Dietary Supplement: Vitamine D supplementation; Other: chronic exercise in whole body vibration (WBV)

• Registration Number: NCT03684837
• Lead Sponsor: Maíra F Pessoa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-20
• Primary Completion: 2018-08-30
• Status Verified: 2018-09
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-24
• Last Update Submitted: 2018-09-24
• Study First Posted: 2018-09-26
• Last Update Posted: 2018-09-26
• Study Completion: 2018-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D vitamine	Vitamine D supplementation	a dose for week
D vitamine placebo	chronic exercise in whole body vibration (WBV)	a dose for week
D vitamine	chronic exercise in whole body vibration (WBV)	a dose for week

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Peripheral strength	before and immediately up to 12 weeks in WBV training.	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.
Body composition	before and immediately up to 12 weeks in WBV training.	Change in electrical bioimpedance measuring the fat mass and lean mass in kilograms each one, in total body
Respiratory strength	before and immediately up to 12 weeks in WBV training.	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.
Balance static and dynamic	before and immediately up to 12 weeks in WBV training.	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.
Gait speed	before and immediately up to 12 weeks in WBV training.	Change in time in seconds registered in Timed Up and Go test
Quality of life measure by WHOQOL	before and immediately up to 12 weeks in WBV training.	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.

Trial Locations

Locations (1)

Federal University of Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil