Vitamin D DeficiencyNCT04319289
Effect of Aerobic Interval Training With Vitamin D Supplement on Functional Capacity and Perceived Myalgia
A study testing aerobic interval training and Vitamin D supplementation,, Vitamin D supplementation only and aerobic interval training only in people with Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to investigate whether there will be an effect of adding a program of aerobic interval training in managing patients suffering from myalgia associated with vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- aerobic interval training and Vitamin D supplementation,, Vitamin D supplementation only and aerobic interval training only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2020to 20 May 2020
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Forty five sedentry women with non specific myalgia pain.
- The patients' ages ranged from 30 -40 years.
- All patients have non specific muscle pain for more than 2 months.
- They have vitamin D deficiency.
- All patients have BMI from 25 to 34.9 kg/m2.
- All patients were clinically and medically stable when attending the study.
Who cannot join
- Unstable cardiovascular and chest problems.
- Patients with diseases which affect vitamin D level as a history of rheumatic or metabolic bone diseases and diabetes.
- Patients taking drugs which affect vitamin D level as steroids and anticonvulsants drugs .
- Musculoskeletal disorders which may affect their physical ability to do the exercises.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aerobic Interval Training Combined With Vitamin D Supplement on Functional Capacity and Perceived Myalgia in Middle Aged Obese Women
This study aimed to investigate whether there will be an effect of adding a program of aerobic interval training in managing patients suffering from myalgia associated with vitamin D deficiency.
Read the detailed description
Forty five women complaining from myalgia with vitamin D deficiency participating in this study. Their ages are ranged from 30 to 40 years.
They are assigned randomly into three groups:
- Group (A): included 15 patients who are participating in an aerobic interval training exercise program with vitamin D supplementation (cholecalciferol 400 IU/day).
- Group (B): included 15 patients who are receiving vitamin D supplementation only (cholecalciferol 400 IU/day).
- Group (C): included 15 patients who are participating in an interval training exercise program only.
The intervention will last for 12 weeks
- Conditions
- Vitamin D Deficiency
- Being tested
- aerobic interval training and Vitamin D supplementation,, Vitamin D supplementation only, aerobic interval training only
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic interval training and Vitamin D supplementation,Other
The participants in both groups A will be instructed to perform aerobic interval exercises at 70% maxHR for 5 minutes and then decrease activity to 50% for 5 minutes and repeat for the length of the activity (the training will be done by using bicycle ergometer(Biodex LBC, Biodex Inc., New York).• Before starting training ; Maximum heart rate calculated from the following equation: maxHR= 220-age .
- Duration: the first five to ten minutes of each session were dedicated to warming up exercise on the bicycle in the form of slow progression exercise (to decrease the risk of hypotension, musculoskeletal injury and cardiovascular complications), followed by the active phase of exercise for 40 min., and finally cooling down phase for ten minutes. with intensity and speed decreased gradually until reaching the resting HR
- Frequency: 3 days/week., for 12 weeks
Also all participants in this group are taking gne capsule containing (cholecalciferol 400 IU) every day .
Vitamin D supplementation onlyDrug
One capsule containing (cholecalciferol 400 IU) was taken every day .
aerobic interval training onlyOther
The participants in group C will be instructed to perform aerobic interval exercises at 70% maxHR for 5 minutes and then decrease activity to 50% for 5 minutes and repeat for the length of the activity (the training will be done by using bicycle ergometer(Biodex LBC, Biodex Inc., New York).• Before starting training ; Maximum heart rate calculated from the following equation: maxHR= 220-age (Gellish ,2007).
- Duration: the first five to ten minutes of each session were dedicated to warming up exercise on the bicycle in the form of slow progression exercise (to decrease the risk of hypotension, musculoskeletal injury and cardiovascular complications), followed by the active phase of exercise for 40 min., and finally cooling down phase for ten minutes. with intensity and speed decreased gradually until reaching the resting heart rate (Broderick et al.,2014).
- Frequency: 3 days/week. The whole training lasting for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Included 15 patients who are participating in an aerobic interval training exercise program with vitamin D supplementation (cholecalciferol 400 IU/day).
The aerobic interval training is conducted for one hour, three days per week on a total period of 12 weeks. Receives: Other: aerobic interval training and Vitamin D supplementation, |
| Group (B) | Experimental | Included 15 patients who are receiving vitamin D supplementation only . One capsule containing (cholecalciferol 400 IU) was taken every day for 12 weeks Receives: Drug: Vitamin D supplementation only |
| Group (c) | Experimental | Included 15 patients who are participating in an aerobic interval training exercise program only. The aerobic interval training is conducted for one hour, three days per week on a total period of 12 weeks. Receives: Other: aerobic interval training only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Plasma Serum vitamin D level (25OHD)
It is performed by Laboratory BioPlex® 2200 System
Measured: It is performed before and after the study(12 weeks interval) for all groups
Description of Functional capacity efficiency
Cooper 12-Minute Walk Test (12MWT)
Measured: It is performed before and after the study(12 weeks interval) for all groups
Intensity of non specific muscle pain (myalgia)
A 10-cm Visual Analogue Scale (VAS) was used to evaluate the patients' pain , with 0 representing no pain and 10 representing the worst pain imaginable
Measured: It is performed before and after the study(12 weeks interval) for all groups
Description of the improvement in Quality of life
The Short form health survey (SF-12)is often used to compare health status between groups of patients, to indentify predictors of health status
Measured: It is performed before and after the study(12 weeks interval) for all groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start12 Jan 2020
- Primary completion15 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ali Abdeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319289
- Sponsor's protocol ID
- 2020HAAE
- Status last verified
- May 2020
- First submitted
- 22 Mar 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Interval Training Combined With Vitamin D Supplement on Functional Capacity and Perceived Myalgia in Middle Aged Obese Women
- ClinicalTrials.gov ID
- NCT04319289
- Acronym / sponsor ID
- 2020HAAE
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 24 Mar 2020 (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.
This study aimed to investigate whether there will be an effect of adding a program of aerobic interval training in managing patients suffering from myalgia associated with vitamin D deficiency.
Detailed description
Forty five women complaining from myalgia with vitamin D deficiency participating in this study. Their ages are ranged from 30 to 40 years.
They are assigned randomly into three groups:
- Group (A): included 15 patients who are participating in an aerobic interval training exercise program with vitamin D supplementation (cholecalciferol 400 IU/day).
- Group (B): included 15 patients who are receiving vitamin D supplementation only (cholecalciferol 400 IU/day).
- Group (C): included 15 patients who are participating in an interval training exercise program only.
The intervention will last for 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Other: aerobic interval training and Vitamin D supplementation,Included 15 patients who are participating in an aerobic interval training exercise program with vitamin D supplementation (cholecalciferol 400 IU/day). The aerobic interval training is conducted for one hour, three days per week on a total period of 12 weeks. |
| Group (B) | Experimental | Drug: Vitamin D supplementation onlyIncluded 15 patients who are receiving vitamin D supplementation only . One capsule containing (cholecalciferol 400 IU) was taken every day for 12 weeks |
| Group (c) | Experimental | Other: aerobic interval training onlyIncluded 15 patients who are participating in an aerobic interval training exercise program only. The aerobic interval training is conducted for one hour, three days per week on a total period of 12 weeks. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Forty five sedentry women with non specific myalgia pain.
- The patients' ages ranged from 30 -40 years.
- All patients have non specific muscle pain for more than 2 months.
- They have vitamin D deficiency.
- All patients have BMI from 25 to 34.9 kg/m2.
Key exclusion criteria (4 listed)
- Unstable cardiovascular and chest problems.
- Patients with diseases which affect vitamin D level as a history of rheumatic or metabolic bone diseases and diabetes.
- Patients taking drugs which affect vitamin D level as steroids and anticonvulsants drugs .
- Musculoskeletal disorders which may affect their physical ability to do the exercises.
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 |
|---|---|---|
| aerobic interval training and Vitamin D supplementation,The participants in both groups A will be instructed to perform aerobic interval exercises at 70% maxHR for 5 minutes and then decrease activity to 50% for 5 minutes and repeat for the length of the activity (the training will be done by using bicycle ergometer(Biodex LBC, Biodex Inc., New York).• Before starting training ; Maximum heart rate calculated from the following equation: maxHR= 220-age . * Duration: the first five to ten minutes of each session were dedicated to warming up exercise on the bicycle in the form of slow progression exercise (to decrease the risk of hypotension, musculoskeletal injury and cardiovascular complications), followed by the active phase of exercise for 40 min., and finally cooling down phase for ten minutes. with intensity and speed decreased gradually until reaching the resting HR * Frequency: 3 days/week., for 12 weeks Also all participants in this group are taking gne capsule containing (cholecalciferol 400 IU) every day . | Other | Group (A) |
| Vitamin D supplementation onlyOne capsule containing (cholecalciferol 400 IU) was taken every day . | Drug | Group (B) |
| aerobic interval training onlyThe participants in group C will be instructed to perform aerobic interval exercises at 70% maxHR for 5 minutes and then decrease activity to 50% for 5 minutes and repeat for the length of the activity (the training will be done by using bicycle ergometer(Biodex LBC, Biodex Inc., New York).• Before starting training ; Maximum heart rate calculated from the following equation: maxHR= 220-age (Gellish ,2007). * Duration: the first five to ten minutes of each session were dedicated to warming up exercise on the bicycle in the form of slow progression exercise (to decrease the risk of hypotension, musculoskeletal injury and cardiovascular complications), followed by the active phase of exercise for 40 min., and finally cooling down phase for ten minutes. with intensity and speed decreased gradually until reaching the resting heart rate (Broderick et al.,2014). * Frequency: 3 days/week. The whole training lasting for 12 weeks | Other | Group (c) |
Primary outcome
Concentration of Plasma Serum vitamin D level (25OHD)
Time frame: It is performed before and after the study(12 weeks interval) for all groups
It is performed by Laboratory BioPlex® 2200 System
Description of Functional capacity efficiency
Time frame: It is performed before and after the study(12 weeks interval) for all groups
Cooper 12-Minute Walk Test (12MWT)
Intensity of non specific muscle pain (myalgia)
Time frame: It is performed before and after the study(12 weeks interval) for all groups
A 10-cm Visual Analogue Scale (VAS) was used to evaluate the patients' pain , with 0 representing no pain and 10 representing the worst pain imaginable
Description of the improvement in Quality of life
Time frame: It is performed before and after the study(12 weeks interval) for all groups
The Short form health survey (SF-12)is often used to compare health status between groups of patients, to indentify predictors of health status
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 2 Jun 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic interval training and Vitamin D supplementation,, Vitamin D supplementation only and aerobic interval training only in people with Vitamin D Deficiency, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 4 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 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Concentration of Plasma Serum vitamin D level (25OHD) (time frame: It is performed before and after the study(12 weeks interval) for all groups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2020.