The Effect of Orally Administered L- Arginine on Quadriceps Strenght in Healthy Smokers

NCT ID: NCT04643600

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-02-17

Brief Summary

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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

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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

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Spirometry Qadriceps Muscle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Smokers

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.

Group Type ACTIVE_COMPARATOR

L-Arginine, 500 Mg Oral Capsule

Intervention Type DRUG

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.

Non - smokers

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.

Group Type ACTIVE_COMPARATOR

L-Arginine, 500 Mg Oral Capsule

Intervention Type DRUG

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.

Interventions

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L-Arginine, 500 Mg Oral Capsule

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* aged 40-65

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Goranka Radmilović

OTHER

Sponsor Role lead

Responsible Party

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Goranka Radmilović

physiatrist, principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Daruvarske Toplice

Daruvar, Bjelovar-Bilogora County, Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Goranka Radmilović, doctor, physiatrist

Role: CONTACT

0981702778

Facility Contacts

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Goranka Radmilović, physiatrist

Role: primary

0981702778

Dinko Kolarić, physiatrist

Role: backup

043/423- 600

Other Identifiers

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2156-61-07-20-170

Identifier Type: -

Identifier Source: org_study_id

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