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

NCT04643600 | Unknown Phase 4 DMC

• 1 other identifier: 2156-61-07-20-170
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Spirometry; Qadriceps Muscle

Keywords

COPD; L-arginine; locomotor parameters; smokers; quadriceps muscle

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day between two tests, 90min after taking L- Arginine a 500mg

Study Arms (2)

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.

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.

Drug: L-Arginine, 500 Mg Oral Capsule

Interventions

L-Arginine, 500 Mg Oral Capsule 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; Smokers

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 40-65

You may not qualify if:

• 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.

Sponsors & Collaborators

• Goranka Radmilović: lead

Study Sites (1)

Daruvarske Toplice

Daruvar, Bjelovar-Bilogora County, 43500, Croatia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Arginine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Central Study Contacts

Goranka Radmilović, doctor, physiatrist

CONTACT

0981702778; grgoga@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physiatrist, principal investigator

Model Details: 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

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: March 1, 2019
• Primary Completion: February 15, 2022
• Study Completion: February 17, 2022
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)