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Behavioral Intervention

Impact Load Exercises for Relative Energy Deficiency in Sport

N/A
Waitlist Available
Led By Enette Larson-Meyer, PhD
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Awards & highlights

Study Summary

This trial will study the effects of high-impact exercise on bone metabolism in female runners who are restricting their energy intake. Volunteers will complete two 5-day experimental conditions in a randomized order, with one month in between. One experimental condition will include a diet of 30 kcal/kg of fat-free mass/day, and the other will include 50 impact loading exercises in addition to daily treadmill running.

Who is the study for?
This trial is for female runners with a stable weight, running at least 30 miles weekly, and having high aerobic capacity (VO2max ≥45 ml/kg/min). They must have regular menstrual cycles without contraceptives, agree to eat provided meals, and have a BMI of 18.5-25.0 kg/m2. Those with recent eating disorders, medications affecting bones, low bone density, abnormal thyroid levels or LEAF-Q score ≥8 can't join.Check my eligibility
What is being tested?
The study tests the effects of high-impact exercises on bone health markers in women who run but consume limited energy. Participants will undergo two conditions: one with their usual running plus impact exercises and another with just running—both paired with controlled diets over separate five-day periods.See study design
What are the potential side effects?
Since this trial involves dietary restrictions and exercise regimens rather than medication or invasive procedures, side effects may include physical fatigue or stress from the increased activity load and potential psychological impacts due to strict diet adherence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 24-hour Glucose Patterns
Change in Blood Metabolic Marker - Insulin-like Growth Factor-1
Change in Blood Metabolic Marker - Parathyroid hormone
+2 more
Secondary outcome measures
Change in Body Weight
Change in Running Economy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Endurance and Jumping ExercisesExperimental Treatment1 Intervention
5 days of endurance treadmill running and 5 sets of 10 jumping exercises
Group II: Endurance Exercise OnlyActive Control1 Intervention
5 days of endurance treadmill running

Find a Location

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityLead Sponsor
139 Previous Clinical Trials
27,676 Total Patients Enrolled
Enette Larson-Meyer, PhDPrincipal InvestigatorVirginia Polytechnic Institute and State University (Virginia Tech)
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Impact Load Exercises (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05341700 — N/A
Relative Energy Deficiency in Sport Research Study Groups: Endurance and Jumping Exercises, Endurance Exercise Only
Relative Energy Deficiency in Sport Clinical Trial 2023: Impact Load Exercises Highlights & Side Effects. Trial Name: NCT05341700 — N/A
Impact Load Exercises (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05341700 — N/A

Frequently Asked Questions

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

Does this trial extend to octogenarians?

"As stipulated by the conditions of this trial, only individuals aged between 18 and 30 are eligible to participate."

Answered by AI

What criteria must potential participants meet to be eligible for enrollment in this study?

"This medical investigation seeks 15 participants, aged 18-30 and currently displaying Relative Energy Deficiency in Sport (RED-S). To be eligible for enrolment, candidates should meet the following standards: female runners with natural menstrual cycles not using contraception; BMI between 18.5 to 25 kg/m2; weight stable by 2 kilograms within 6 months; running volume of no less than 30 miles per week at least five days each week, a VO2 max rate of 45 ml/kg/min or higher, and readiness to consume meals and snacks provided."

Answered by AI

Is there still room for individuals to participate in this study?

"According to clinicaltrials.gov, this medicinal study is actively recruiting participants since its announcement on August 24th 2022 and most recent version update of September 6th 2022."

Answered by AI

To what extent are individuals partaking in this investigation?

"Confirmation can be found on clinicaltrials.gov that this research is presently enrolling participants, with the first posting dated August 24th 2022 and an updated revision published September 6th 2022. The required number of volunteers for inclusion in the trial is 15 across 1 site."

Answered by AI
~6 spots leftby Mar 2025