NCT02485197

Brief Summary

This is a small pilot aerobic training trial designed to examine differences between normal-high and low vitamin D levels and 7-days of aerobic training on local VO2 measured by non-invasive Hybrid Diffuse Optical Spectroscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

April 25, 2013

Last Update Submit

March 15, 2017

Conditions

Keywords

Muscle Metabolic FunctionVitamin D Status25(OH)DOlder Adults

Outcome Measures

Primary Outcomes (1)

  • Muscle VO2 consumption

    The objective is to examine the difference in gastrocnemius VO2 consumption in individuals that either have normal-high or low 25(OH)D and are undergoing 7-days of a treadmill training program.

    Up to 3 months

Study Arms (2)

Low 25(OH)D

OTHER

We will recruit individuals with low 25(OH)D (\<30ng/mL).

Other: 7 continuous days of aerobic training

High 25(OH)D

OTHER

We will recruit individuals with higher 25(OH)D (at least 20ng/mL units higher then that of the "low 25(OH)D group).

Other: 7 continuous days of aerobic training

Interventions

For 7 consecutive days, subjects will perform up to 45 minutes of exercise consisting of treadmill walking at a progressive intensity of about 60-65% of their maximum heart rate. This heart rate range is estimated to be below 60% VO2 max.

High 25(OH)DLow 25(OH)D

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age

You may not qualify if:

  • Currently have or have a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise.
  • Uncontrolled diabetes or hypertension.
  • History of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity
  • History of leg/hip trauma, inflammation, infection rhabdomyolysis, or leg surgery in the past 3 months
  • Have a diagnosis of osteoporosis (as determined by DXA)
  • Participated in a resistance or aerobic training program in the last 3 months
  • Engage in more than 1 hr/week of vigorous activity
  • Body mass index \>29
  • On hormone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • David T Thomas, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR
  • Maja Redzic, MS

    University of Kentucky

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D., RD, CSSD, CSCS

Study Record Dates

First Submitted

April 25, 2013

First Posted

June 30, 2015

Study Start

March 1, 2013

Primary Completion

October 1, 2013

Study Completion

June 1, 2015

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations