An interventional study of Impact Load Exercises and No Impact Load Exercises in Relative Energy Deficiency in Sport, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Prevention
This study is a randomized, cross-over intervention study that will evaluate the effect of brief, high-impact loading exercises on biomarkers of bone metabolism in energy-restricted female runners. Volunteers will complete two 5-day experimental conditions in a randomized order separated by one menstrual cycle (approximately 3 weeks). Experimental conditions will include a dietary intervention of energy intake equal to 30 kcal/kg of fat-free mass/d using controlled diets and an exercise intervention of daily treadmill running with or without an additional 50 impact loading exercises.
Many long-distance runners struggle to consume enough calories each day to match the number of calories they are burning during exercise and as part of daily living. Undereating for long periods of time is a serious concern because it can have negative effects on general health and sports performance. One of these long-term consequences is related to bone health. With undereating, bone can start to be broken down faster than it can be rebuilt. Even though it can take months, and even years, for bone to be seriously affected, this may lead to weak and brittle bones later in life, if it is left untreated. Typically, athletes are recommended to increase the number of calories they eat to prevent negative health concerns. However, not all athletes may be willing or able to increase their calories based on their performance goals, nutrition knowledge, or concerns with food security. This means that alternative strategies need to be investigated to counteract the negative effects of undereating on bone health. This study proposes to evaluate the effect of adding short bouts of high-impact jumping exercises to typical endurance training to promote healthy bone metabolism. This will specifically involve completing two phases of a supervised treadmill run and consuming a reduced-calorie diet (provided by the research team) on 5 consecutive days. In addition, one of the phases will include performing 5 sets of 10 jumping exercises on 5 consecutive days in addition to the treadmill run. Results of the study will serve as an important first step in helping exercise and medical professionals understand more about how to protect and manage the bone health of female long-distance runners.
20 studies on the registry are indexed under Relative Energy Deficiency in Sport; 10 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 11 interventional studies indexed under Relative Energy Deficiency in Sport.
Browse Relative Energy Deficiency in Sport studies →Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
5 days of endurance treadmill running and 5 sets of 10 jumping exercises
Behavioral: Impact Load Exercises
5 days of endurance treadmill running
Behavioral: No Impact Load Exercises
Participants will complete 50-65 min running protocol on treadmill and 5 sets of 10 jumping exercises for 5 consecutive days. Participants will also be provided all meals and snacks to induce a energy-restricted state for the 5-day period.
Participants will complete only a 50-65 min running protocol on treadmill for 5 consecutive days. Participants will also be provided all meals and snacks to induce a energy-restricted state for the 5-day period.
Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen
Plasma N-terminal propeptide of type 1 procollagen (PINP) was collected from fasted blood samples drawn before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.
Time frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Change in Bone Remodeling Biomarker - C-terminal Telopeptide of Type 1 Collagen (CTX)
Serum C-terminal telopeptide of type 1 collagen (CTX) was collected from fasted blood samples drawn before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.
Time frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Change in Blood Metabolic Marker - Parathyroid Hormone
Parathyroid hormone levels were measured from fasted blood samples collected before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.
Time frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Change in Blood Metabolic Marker - Insulin-like Growth Factor-1
Insulin-like growth factor-1 (IGF1) concentration was measured from fasted blood samples collected before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.
Time frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
Change in Ferritin
Fasted serum ferritin was measured before and after each 5-day intervention period.
Time frame: 10-minute blood draw in laboratory; samples assessed on intervention day 0 and day 6
38 individuals were screened for eligibility between August 2, 2022 and October 13, 2023 in Southwest Virginia.
| Milestone | RUN, Then RUN+J | RUN+J, Then RUN |
|---|---|---|
| Started | 7 | 7 |
| Completed | 6 | 7 |
| Not completed | 1 | 0 |
| Milestone | RUN, Then RUN+J | RUN+J, Then RUN |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 5 |
| Not completed | 0 | 2 |
| Milestone | RUN, Then RUN+J | RUN+J, Then RUN |
|---|---|---|
| Started | 6 | 5 |
| Completed | 5 | 5 |
| Not completed | 1 | 0 |
Plasma N-terminal propeptide of type 1 procollagen (PINP) was collected from fasted blood samples drawn before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.
| ng/mL | Endurance and Jumping Exercises (RUN+J) | Endurance Exercise Only (RUN) |
|---|---|---|
| Change in Bone Remodeling Biomarker - N-terminal Propeptide of Type 1 Procollagen | -3.1 ± 5.7 | 1.1 ± 7.2 |
Serum C-terminal telopeptide of type 1 collagen (CTX) was collected from fasted blood samples drawn before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.
| ng/mL | Endurance and Jumping Exercises (RUN+J) | Endurance Exercise Only (RUN) |
|---|---|---|
| Change in Bone Remodeling Biomarker - C-terminal Telopeptide of Type 1 Collagen (CTX) | 0.04 ± 0.09 | 0.04 ± 0.12 |
Parathyroid hormone levels were measured from fasted blood samples collected before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.
| pg/mL | Endurance and Jumping Exercises (RUN+J) | Endurance Exercise Only (RUN) |
|---|---|---|
| Change in Blood Metabolic Marker - Parathyroid Hormone | 3.3 ± 6.1 | -1.0 ± 11.8 |
Insulin-like growth factor-1 (IGF1) concentration was measured from fasted blood samples collected before and after each 5-day intervention. The enzyme-linked immunosorbent assays (ELISA) were performed on all samples upon study completion.
| ng/mL | Endurance and Jumping Exercises (RUN+J) | Endurance Exercise Only (RUN) |
|---|---|---|
| Change in Blood Metabolic Marker - Insulin-like Growth Factor-1 | -11.4 ± 10.3 | -8.0 ± 6.3 |
Fasted serum ferritin was measured before and after each 5-day intervention period.
| ng/mL | Endurance and Jumping Exercises (RUN+J) | Endurance Exercise Only (RUN) |
|---|---|---|
| Change in Ferritin | 4.1 ± 11.3 | 11.4 ± 11.5 |
Collected over One week for each intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Endurance and Jumping Exercise (RUN+J) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Endurance Exercise Only (RUN) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(Years) | RUN, Then RUN+J | RUN+J, Then RUN | Total |
|---|---|---|---|
| Mean | 25.3 ± 4.2 | 26.9 ± 3.6 | 26.2 ± 3.8 |
| Sex: Female, Male(Participants) | RUN, Then RUN+J | RUN+J, Then RUN | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | RUN, Then RUN+J | RUN+J, Then RUN | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Virginia Polytechnic Institute and State University