SpirometryPhase 4NCT04643600
The Effect of Orally Administered L- Arginine on Quadriceps Strenght in Healthy Smokers
A Phase 4 study testing L-Arginine, 500 Mg Oral Capsule in people with Spirometry and Qadriceps Muscle, run by Goranka Radmilović at 1 site in Croatia.
Trial summary
The study will investigate changes in certain locomotor parameters as early predictors of disease in smokers who are prone to develop chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spirometry, Qadriceps Muscle
- What is being tested?
- L-Arginine, 500 Mg Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Mar 2019to 17 Feb 2022
- Phase
- Phase 4
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 40-65
- smokers and non-smokers, All patients will make spirometry and the Tiffeneau-Pinelli index (ratio of forced expiratory volume in 1 second - FEV1 and forced vital capacity FVC)> 75% of the predictive value will be taken as an inclusion criteria.
Who cannot join
- FEV1 / FVC <75%,
- inflammatory rheumatic diseases,
- malignancies,
- acute and severe heart or lung disease,
- unregulated hypertension,
- patients who have undergone major surgery in the past year,
- patients with implanted hip, knee or ankle prosthesis, will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Daruvarske Toplice
Daruvar, Bjelovar-Bilogora County, 43500
Goranka Radmilović, physiatrist, 0981702778, grgoga@gmail.com
Dinko Kolarić, physiatrist, 043/423- 600, dinko.kolaric@gmail.com
About this study
The study will investigate changes in certain locomotor parameters as early predictors of disease in smokers who are prone to develop chronic obstructive pulmonary disease (COPD).
Read the detailed description
The research will include about 150 respondents aged 40-65, smokers and non-smokers, and will be conducted at the Special Hospital for Medical Rehabilitation 'Daruvarske toplice'. All patients will make spirometry and the Tiffeneau-Pinelli index (ratio of forced expiratory volume in 1 second - FEV1 and forced vital capacity FVC).
All patients will be maesured: body weight, height, BMI (body mass index), waist circumference, pulse (cp), saturation (SpO2), blood pressure, respiratory index and thoracic spine mobility index measured. The thickness of the skin fold will be measured on the abdomen with a caliper and on the measuring device for the analysis of body mass composition - Gaia, the percentage of muscle and fat tissue will be determined for each patient, as well as the analysis of body mass composition. All patients will do a 6-minute walk test and the patient's cardiorespiratory and muscular ability will be tested on a bicycle erogometer, the values of maximal oxygen uptake (VO2 max) and pulse (cp) will be recorded and the patient's fitness status determined. Each patient will estimate dyspnea intensity from 1 -10 before and after a 6-minute walk test and before and after a bicycle ergometer according to the Borg's dyspnea scale. The strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength. All patients who are smokers will have recorded : the age of onset of smoking, the year of smoking experience and the average number of cigarettes smoked per day. All patients will complete the CAT, IPAQ and DASS-21 questionnaire.
- Conditions
- Spirometry, Qadriceps Muscle
- Being tested
- L-Arginine, 500 Mg Oral Capsule
- Keywords
- COPD, L-arginine, locomotor parameters, smokers, quadriceps muscle
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Arginine, 500 Mg Oral CapsuleDrug
The strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Active comparator | The strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength. All patients who are smokers will have recorded : the age of onset of smoking, the year of smoking experience and the average number of cigarettes smoked per day. All patients will complete the CAT, IPAQ and DASS-21 questionnaire. Receives: Drug: L-Arginine, 500 Mg Oral Capsule |
| Non - smokers | Active comparator | All patients will be maesured: body weight, height, BMI (body mass index), waist circumference, pulse (cp), saturation (SpO2), blood pressure, respiratory index and thoracic spine mobility index measured. All patients will do a 6-minute walk test and test on a bicycle erogometer. The strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength. All patients will complete the CAT, IPAQ and DASS-21 questionnaire. Receives: Drug: L-Arginine, 500 Mg Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps strenght
Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible change in quadriceps strength.
Measured: 1 day between two tests, 90min after taking L- Arginine a 500mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Mar 2019
- Primary completion15 Feb 2022 (estimated)
- Study completion17 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpirometryStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The research will be organized as a cross-sectional study that will include patients, smokers and non-smokers, who are undergoing medical rehabilitation or medically programmed vacation in the Special Hospital for Medical Rehabilitation Daruvarske toplice
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goranka Radmilović
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Goranka Radmilović, Daruvarske Toplice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643600
- Sponsor's protocol ID
- 2156-61-07-20-170
- Status last verified
- Aug 2021
- First submitted
- 19 Nov 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orally Administered L- Arginine on Quadriceps Strenght in Healthy Smokers
- ClinicalTrials.gov ID
- NCT04643600
- Acronym / sponsor ID
- 2156-61-07-20-170
- Conditions
- Spirometry, Qadriceps Muscle
- Keywords
- COPD, L-arginine, locomotor parameters, smokers, quadriceps muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Goranka RadmilovićUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 17 Feb 2022 (estimated)
- First posted
- 25 Nov 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.
The study will investigate changes in certain locomotor parameters as early predictors of disease in smokers who are prone to develop chronic obstructive pulmonary disease (COPD).
Detailed description
The research will include about 150 respondents aged 40-65, smokers and non-smokers, and will be conducted at the Special Hospital for Medical Rehabilitation 'Daruvarske toplice'. All patients will make spirometry and the Tiffeneau-Pinelli index (ratio of forced expiratory volume in 1 second - FEV1 and forced vital capacity FVC).
All patients will be maesured: body weight, height, BMI (body mass index), waist circumference, pulse (cp), saturation (SpO2), blood pressure, respiratory index and thoracic spine mobility index measured. The thickness of the skin fold will be measured on the abdomen with a caliper and on the measuring device for the analysis of body mass composition - Gaia, the percentage of muscle and fat tissue will be determined for each patient, as well as the analysis of body mass composition. All patients will do a 6-minute walk test and the patient's cardiorespiratory and muscular ability will be tested on a bicycle erogometer, the values of maximal oxygen uptake (VO2 max) and pulse (cp) will be recorded and the patient's fitness status determined. Each patient will estimate dyspnea intensity from 1 -10 before and after a 6-minute walk test and before and after a bicycle ergometer according to the Borg's dyspnea scale. The strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength. All patients who are smokers will have recorded : the age of onset of smoking, the year of smoking experience and the average number of cigarettes smoked per day. All patients will complete the CAT, IPAQ and DASS-21 questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The research will be organized as a cross-sectional study that will include patients, smokers and non-smokers, who are undergoing medical rehabilitation or medically programmed vacation in the Special Hospital for Medical Rehabilitation Daruvarske toplice
| Arm | Type | Receives |
|---|---|---|
| Smokers | Active comparator | Drug: L-Arginine, 500 Mg Oral CapsuleThe strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength. All patients who are smokers will have recorded : the age of onset of smoking, the year of smoking experience and the average number of cigarettes smoked per day. All patients will complete the CAT, IPAQ and DASS-21 questionnaire. |
| Non - smokers | Active comparator | Drug: L-Arginine, 500 Mg Oral CapsuleAll patients will be maesured: body weight, height, BMI (body mass index), waist circumference, pulse (cp), saturation (SpO2), blood pressure, respiratory index and thoracic spine mobility index measured. All patients will do a 6-minute walk test and test on a bicycle erogometer. The strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength. All patients will complete the CAT, IPAQ and DASS-21 questionnaire. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 40-65
- smokers and non-smokers, All patients will make spirometry and the Tiffeneau-Pinelli index (ratio of forced expiratory volume in 1 second - FEV1 and forced vital capacity FVC)> 75% of the predictive value will be taken as an inclusion criteria.
Key exclusion criteria (7 listed)
- FEV1 / FVC <75%,
- inflammatory rheumatic diseases,
- malignancies,
- acute and severe heart or lung disease,
- unregulated hypertension,
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 |
|---|---|---|
| L-Arginine, 500 Mg Oral CapsuleThe strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength. | Drug | Non - smokers, Smokers |
Primary outcome
Quadriceps strenght
Time frame: 1 day between two tests, 90min after taking L- Arginine a 500mg
Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible change in quadriceps strength.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-Arginine, 500 Mg Oral Capsule in people with Spirometry and Qadriceps Muscle, run by Goranka Radmilović at 1 site in Croatia.
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 7 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. 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 Croatia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Goranka Radmilović, doctor, physiatrist (0981702778, grgoga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps strenght (time frame: 1 day between two tests, 90min after taking L- Arginine a 500mg). 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 23 Aug 2021.