Muscle Metabolic Function in Older Adults With Different Vitamin D Status Before and After Exercise

March 15, 2017 updated by: David Travis Thomas

A Pilot Study Investigating Differences in Muscle Metabolic Function in Individuals Aged 65-75 Years With Different Vitamin D Status Before and After 7-days of Aerobic Training

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65-75 years of age

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low 25(OH)D
We will recruit individuals with low 25(OH)D (<30ng/mL).
Other: 7 continuous days of aerobic training
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.
Other: High 25(OH)D
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle VO2 consumption
Time Frame: Up to 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Travis Thomas

Investigators

  • Principal Investigator: David T Thomas, PhD, University of Kentucky
  • Study Director: Maja Redzic, MS, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 25, 2013

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1029-F6A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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