Bone DensityNCT03308292
Effects of an Exercise Program on Bone Density
A study testing Exercise in people with Bone Density and Body Composition, run by Universidad Europea de Madrid.
Trial summary
Physical inactivity and low adherence to the Mediterranean diet cause alterations in body composition, which increases the risk factors for cardiovascular and metabolic diseases. In addition, exercise in different surfaces or water could affect the bone density specially in women. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density, Body Composition
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 23 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not diagnosed with any disease that contraindicates the practice of physical exercise
- Do not perform physical activity with continuity
Who cannot join
- Diagnosed with chronic disease including cardiovascular and respiratory diseases that contraindicate the practice of physical exercise
- Being pregnant before or during the intervention (for intervention and control group)
About this study
Official title: Effects of Exercise in Different Sport Surfaces, Diet and Lifestyle in the Bone Density of Pre and Post Menopausal Women
Physical inactivity and low adherence to the Mediterranean diet cause alterations in body composition, which increases the risk factors for cardiovascular and metabolic diseases. In addition, exercise in different surfaces or water could affect the bone density specially in women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic exercise program in different surfaces on the body composition and bone density of women within at work, and to evaluate the quality of the Mediterranean diet and distribution of macronutrients in the studied population. Material \& Methods: Randomized controlled trial. 63 women from a randomized work environment (IG, n=34) and a control group (CG, n=29) participated in a short-term aerobic exercise programmed (12 weeks), for body composition and bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for macronutrient distribution were used.
- Conditions
- Bone Density, Body Composition
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Aerobic exercise program
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Intervention Group | Experimental | A moderate-intensity aerobic physical exercise programme was carried out during the months of March to May 2017 (12 weeks), with a frequency of three sessions per week (36 sessions in total) with a duration of 45 minutes per session. The intensity was controlled through the Borg 1982 modified scale of perceived exertion (RPE). It is a scale from 0 to 10, considering 0 as "nothing at all" and 10 as "very very strong", setting the moderate intensity as value Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone density
Change from baseline to 3 months using Dual-energy X-ray Absorptiometry
Measured: 3 months
Changes in body composition
Change from baseline to 3 months using Dual-energy X-ray Absorptiometry
Measured: 3 months
Secondary outcomes (3)
Level of compliance with the exercise program
Level of compliance with the program using the percentage of compliance to the exercise programme (36 sessions)
Measured: 3 months
Changes in Dietary pattern variables: macronutrients
Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries
Measured: 3 months
Changes in Dietary pattern variables: quality of diet
Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start9 Jan 2017
- Primary completion8 Jul 2017
- Study completion23 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÁLVARO FERNÁNDEZ LUNA, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308292
- Sponsor's protocol ID
- P2016/UEM33
- Status last verified
- Oct 2017
- First submitted
- 7 Oct 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Iturriaga T, Barcelo O, Diez-Vega I, Cordero J, Pulgar S, Fernandez-Luna A, Perez-Ruiz M. Effects of a short workplace exercise program on body composition in women: A randomized controlled trial. Health Care Women Int. 2020 Feb;41(2):133-146. doi: 10.1080/07399332.2019.1679813. Epub 2019 Oct 22.
PubMed 31638477
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise in Different Sport Surfaces, Diet and Lifestyle in the Bone Density of Pre and Post Menopausal Women
- ClinicalTrials.gov ID
- NCT03308292
- Acronym / sponsor ID
- P2016/UEM33
- Conditions
- Bone Density, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 8 Jul 2017 (actual)
- Study completion
- 23 Jul 2017 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical inactivity and low adherence to the Mediterranean diet cause alterations in body composition, which increases the risk factors for cardiovascular and metabolic diseases. In addition, exercise in different surfaces or water could affect the bone density specially in women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic exercise program in different surfaces on the body composition and bone density of women within at work, and to evaluate the quality of the Mediterranean diet and distribution of macronutrients in the studied population. Material \& Methods: Randomized controlled trial. 63 women from a randomized work environment (IG, n=34) and a control group (CG, n=29) participated in a short-term aerobic exercise programmed (12 weeks), for body composition and bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for macronutrient distribution were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Intervention Group | Experimental | Other: ExerciseA moderate-intensity aerobic physical exercise programme was carried out during the months of March to May 2017 (12 weeks), with a frequency of three sessions per week (36 sessions in total) with a duration of 45 minutes per session. The intensity was controlled through the Borg 1982 modified scale of perceived exertion (RPE). It is a scale from 0 to 10, considering 0 as "nothing at all" and 10 as "very very strong", setting the moderate intensity as value |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Not diagnosed with any disease that contraindicates the practice of physical exercise
- Do not perform physical activity with continuity
Key exclusion criteria (2 listed)
- Diagnosed with chronic disease including cardiovascular and respiratory diseases that contraindicate the practice of physical exercise
- Being pregnant before or during the intervention (for intervention and control group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAerobic exercise program | Other | Intervention Group |
Primary outcome
Changes in bone density
Time frame: 3 months
Change from baseline to 3 months using Dual-energy X-ray Absorptiometry
Changes in body composition
Time frame: 3 months
Change from baseline to 3 months using Dual-energy X-ray Absorptiometry
3 secondary outcomes
Level of compliance with the exercise program
Time frame: 3 months
Changes in Dietary pattern variables: macronutrients
Time frame: 3 months
Changes in Dietary pattern variables: quality of diet
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Derived from this study: PubMed 31638477Iturriaga T, Barcelo O, Diez-Vega I, Cordero J, Pulgar S, Fernandez-Luna A, Perez-Ruiz M. Effects of a short workplace exercise program on body composition in women: A randomized controlled trial. Health Care Women Int. 2020 Feb;41(2):133-146. doi: 10.1080/07399332.2019.1679813. Epub 2019 Oct 22.
- Individual participant dataSharing planned: Undecided
Related trials for Bone Density
Recruiting
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Bone Mineral Density, Primary Implant Stability
RecruitingObservational study
Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density
Acute Lymphoblastic Leukemia
Not yet recruitingObservational study
Comparing Lumbar Fusion With and Without Stress Endplate Augmentation in Patients With Low Bone Mass
Degenerative Lumbar Disease
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Bone Density and Body Composition, run by Universidad Europea de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in bone density (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.