Back to resultsMuscle Metabolic Function in Older Adults With Different Vitamin D Status Before and After Exercise
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
7 continuous days of aerobic training
Sponsored by
About this trial
This is an interventional screening trial for Vitamin D Deficiency focused on measuring Muscle Metabolic Function, Vitamin D Status, 25(OH)D, Older Adults
Eligibility Criteria
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
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Low 25(OH)D
High 25(OH)D
Arm Description
We will recruit individuals with low 25(OH)D (<30ng/mL).
We will recruit individuals with higher 25(OH)D (at least 20ng/mL units higher then that of the "low 25(OH)D group).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02485197
Brief Title
Muscle Metabolic Function in Older Adults With Different Vitamin D Status Before and After Exercise
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Travis Thomas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Muscle Metabolic Function, Vitamin D Status, 25(OH)D, Older Adults
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low 25(OH)D
Arm Type
Other
Arm Description
We will recruit individuals with low 25(OH)D (<30ng/mL).
Arm Title
High 25(OH)D
Arm Type
Other
Arm Description
We will recruit individuals with higher 25(OH)D (at least 20ng/mL units higher then that of the "low 25(OH)D group).
Intervention Type
Other
Intervention Name(s)
7 continuous days of aerobic training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle VO2 consumption
Description
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.
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T Thomas, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maja Redzic, MS
Organizational Affiliation
University of Kentucky
Official's Role
Study Director
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Muscle Metabolic Function in Older Adults With Different Vitamin D Status Before and After Exercise
We'll reach out to this number within 24 hrs