← Back to Search

Exercise + Calcium Supplementation for Osteoporosis (ESkAPE Trial)

N/A
Recruiting
Led By Wendy M Kohrt, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women will be premenopausal with regular menstrual cycles or postmenopausal, defined as absence of menses for at least 12 mo or, in those who underwent a hysterectomy, a serum follicle stimulating hormone (FSH) >30 mIU/mL
Female and male Veterans aged 25 to 45 y and 55 to 75 y
Timeline
Screening 3 weeks
Treatment Varies
Follow Up bmd of the lumbar spine and proximal femur is measured at baseline
Awards & highlights

ESkAPE Trial Summary

This trial will test whether pre-exercise supplemental calcium can help improve bone health for veterans by looking at the effects of exercise on blood calcium levels.

Who is the study for?
This trial is for male and female Veterans aged 25-45 and 55-75 who are normally active but not in regular intense exercise. Women must be pre or postmenopausal with specific hormonal levels. Exclusions include severe bone density loss, kidney issues, uncontrolled thyroid/blood calcium levels, high blood pressure, type 1 diabetes, recent fractures, obesity, certain heart conditions or anemia.Check my eligibility
What is being tested?
The study tests if taking supplemental calcium before endurance exercises can help maintain blood calcium levels during workouts to improve bone health. It aims to provide better exercise and nutrition guidelines to reduce fracture risk in Veterans.See study design
What are the potential side effects?
While the trial does not mention specific side effects of the interventions (exercise and potential calcium supplements), common concerns may include muscle soreness from exercise or gastrointestinal discomfort from supplements.

ESkAPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman who is either premenopausal with regular periods or postmenopausal.
Select...
I am a veteran aged between 25-45 or 55-75.

ESkAPE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~serum po4 is measured before (-15, 0 minutes), during (15, 30, 45, 60 minutes), and after (15, 30, 60, 120, 180, 240 minutes, 24 hours) the 1st, 8th, and 16th exercise sessions
This trial's timeline: 3 weeks for screening, Varies for treatment, and serum po4 is measured before (-15, 0 minutes), during (15, 30, 45, 60 minutes), and after (15, 30, 60, 120, 180, 240 minutes, 24 hours) the 1st, 8th, and 16th exercise sessions for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C-terminal peptide of type 1 collagen (CTX)
Procollagen 1 intact N-terminal propeptide (P1NP)
Secondary outcome measures
Hematocrit (Hct)
Hemoglobin (Hgb)
P1NP
+5 more
Other outcome measures
Bone mineral density (BMD)
Fat mass (FM)
Fat-free mass (FFM)
+2 more

ESkAPE Trial Design

1Treatment groups
Experimental Treatment
Group I: ExerciseExperimental Treatment1 Intervention
All participants engage in exercise training

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,399 Total Patients Enrolled
3 Trials studying Exercise
598 Patients Enrolled for Exercise
Wendy M Kohrt, PhDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO
2 Previous Clinical Trials
136 Total Patients Enrolled

Media Library

Endurance exercise intervention Clinical Trial Eligibility Overview. Trial Name: NCT05029128 — N/A
Exercise Research Study Groups: Exercise
Exercise Clinical Trial 2023: Endurance exercise intervention Highlights & Side Effects. Trial Name: NCT05029128 — N/A
Endurance exercise intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05029128 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a part of this clinical trial?

"This medical study is seeking 30 individuals with bone resorption that are aged between 25 and 75 years old. To meet the enrolment criteria, male or female veterans must be within these age ranges (25-45; 55-75). In addition, it's necessary for participants to keep a low level of physical activity such as recreational cycling or walking, while women should either have regular menstrual cycles or demonstrate postmenopausal status through an FSH test result >30mIU/mL if they had a hysterectomy."

Answered by AI

What is the cap on participants for this clinical trial?

"Affirmative. Information on clinicaltrials.gov indicates that this medical research is presently seeking volunteers, having first been posted April 1st 2022 and updated most recently on the 11th of that same month. The trial requires 30 participants from a single site to be enrolled in order to proceed."

Answered by AI

Are there any vacancies available in this scientific experiment for participants?

"Affirmative. According to clinicaltrials.gov, this research endeavor is currently recruiting subjects. The venture was initially posted on April 1st 2022 and its details have been revised most recently on April 11th 2022. A total of 30 participants need to be recruited from a single medical centre for the study's completion."

Answered by AI

Is this research endeavor open to individuals aged 25 and over?

"To be eligble for this trial, potential participants must not be too old or too young; the acceptable age range is between 25 and 75 years."

Answered by AI

What are the primary objectives of this research trial?

"This clinical trial is designed to assess the change in CTX (dCTX) from before exercise to the peak during 4 hours of recovery, measured during 1st, 8th, and 16th sessions. The primary aim also includes Procollagen 1 intact N-terminal propeptide (P1NP). Secondary objectives look at Serum ionized Ca (iCa), Serum parathyroid hormone (PTH) and serum P1NP as potential indicators of an acute anabolic response in bone tissue post-exercise or after training."

Answered by AI
~7 spots leftby Sep 2024