Primary Immune DeficiencyNCT06014463
Evaluation of Adult Patients With Immunodeficiency Within the Scope of the ICF
An observational study of Primary Immune Deficiency and Exercise Capacity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Primary immunodeficiency is a clinically, immunologically, and genetically heterogeneous group of diseases that occur as a result of quantitative and/or qualitative deficiency of one or more cellular and molecular components belonging to the immune system. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Immune Deficiency, Exercise Capacity, Physical Activity
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 Jan 2024
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the ages of 18-65 who have been diagnosed with immunodeficiency at Başkent University Hospital Immunology Department and Gülhane Hospital Immunology Department and who are willing to participate in the research and 18-65 patients who are diagnosed with immunodeficiency will be accepted for the study. The snowball sampling method will be used for our control group. We plan to contact the patient's relatives and then contact someone else in the same way. At the same time, we plan to prepare a text explaining each method and reach people through social media.
Criteria for Inclusion in the Adult Immunodeficiency Group
- to be between the ages of 18-65 years old.
- to be volunteer to participate in research
- to have been diagnosed with Primary Immunodeficiency
- to be taking immunoglobulin replacement therapy
- to have no problems in reading and/or understanding scales and being able to cooperate with tests
Criteria for exclusion of the Adult Immunodeficiency Group:
- The presence of active infection
- Musculoskeletal and neurological disease that may affect exercise performance symptomatic heart disease
- To have a neurological disease or other clinical diagnosis that may affect cognitive status
Criteria for inclusion in the control group:
- to be between the ages of 18-65 years old
- to give informed consent
- to have no problems in reading and/or understanding scales and being able to cooperate with tests
Criteria for exclusion of the Control Group:
- to have any orthopedic or neuromuscular disorder that will interfere with walking or exercise performance,
- to have any chronic disease or to have psychiatric disorders or mental influences that may prevent cooperation or compliance with exercise tests.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ebru Çalık Kutukcu
Ankara, Hacettepe Unıversity, 06100
About this study
Official title: Evaluation of Adult Patients With Immunodeficiency Within the Scope of the International Classification of Functionality, Ability and Health
Primary immunodeficiency is a clinically, immunologically, and genetically heterogeneous group of diseases that occur as a result of quantitative and/or qualitative deficiency of one or more cellular and molecular components belonging to the immune system. This classification, called the International Classification of Functioning, Disability and Health ( ICF), constitutes a common language and perspective for the definition of health and health-related conditions. This study aimed to evaluate the body structure function, activity and participation limitations of adult immunodeficiency patients within the scope of ICF and to compare body structure function, activity and participation limitations and compare with healthy people.
Read the detailed description
Primary immunodeficiency is a clinically, immunologically and genetically heterogeneous group of diseases that occur as a result of quantitative and/or qualitative deficiency of one or more cellular and molecular components belonging to the immune system. The overall prevalence of PID in the world is stated as 1/2,000-1/10,000 per live birth. In our country, the national PID registration system has just been established. It is estimated that this rate is higher in developing countries such as Turkey, where there is a lot of inbreeding. The clinical appearance of PID is highly variable; however, most often it is characterized by an increased predisposition to infection. Therefore, the disease manifests itself with infections that are "recurrent and difficult to respond to treatment". PID, which mostly starts to give symptoms in childhood, are in the category of rare diseases. For this reason, the probability of receiving a diagnosis in primary and second-line healthcare institutions is very low. Since the course of the disease is poor in a significant part of PID, early diagnosis and timely treatment are very important for reducing mortality, morbidity and economic burden. This is possible with the level of social awareness and the high index of suspicion of medical personnel. For the successful management of the disease, the patient should be quickly referred to a clinical immunologist experienced in immunodeficiencies and further tests should be performed. Fifteen years ago, the Jeffrey Modell Foundation (JMF) identified clinical signs that arouse suspicion of PID in children and adults. This document is a useful basis, but revision is required because it does not take into account the autoimmune, inflammatory or malignant manifestations of PID, which may be the cause of the main clinical presentation in some of the PID. Pulmonary complications are common in PID and contribute significantly to the morbidity and mortality of patients. Recurrent respiratory infections (more than 2 per year for children and within 3 years for adults) are one of the 10 warning signs of PİY recommended by the Jeffrey Modell Foundation and are often the cause of death in adults with PID. Especially in PID, which is characterized by antibody deficiency, frequent recurrent upper and lower respiratory tract infections lead to chronic complications in tissues and organs. Bronchiectasis is the prominent one among these. According to the European Society of Immunodeficiencies, bronchiectasis develops in ~23% of patients with NDI (one-third of all PID patients) . It has been shown that the general state of health, psychosocial well-being level and quality of life are low in patients with PI who have developed chronic lung disease, and it has been found that their daily activities are significantly limited.
This classification, called the International Classification of Functioning, Disability and Health (ICF), was developed in 2000 to create a common language and perspective for the definition of health and health-related conditions. Objectives of the ICF classification:
- To create a scientifically based approach to determine health and health-related conditions
- To facilitate and increase communication between all health professionals and individuals in different professional groups and to ensure the formation of a common language Dec
- To ensure the determination of health-related applications
- Coding health-related factors with a specific system ICF provides the functional status of individuals and the identification of problems that they may encounter in daily life from a biopsychosocial point of view.
ICF-CY evaluates health-related situations with a total of 1685 items in 4 sections. The fact that it has so much substance constitutes a disadvantage in terms of its use. For this reason, with the ICF Core Sets Project study in 2003, disease-specific core sets were created by selecting categories that are specific to diseases and can fully identify the patient. Core sets, just like ICF, treat the patient holistically. Each set has 2 separate forms in the form of short form and long form. There are 5 core sets that can evaluate cardiopulmonary system disorders. Cardiopulmonary disorders, obesity, diabetes mellitus, COPD, chronic ischemic heart problems are the core sets. In a study conducted on 40 pediatric patients with and without cystic fibrosis, it was shown that the ICF model is applicable and useful in evaluating body function and structure disorders such as November muscle weakness, postural anomalies, and limitations in activity and participation in daily life, and in creating a treatment plan. a study conducted on 24 lung transplant patients showed that the ICF model is practical and applicable in the clinic for evaluating activity and participation restrictions such as decreased exercise capacity, body structure and function disorders such as postural disorders, physical activity in daily life, balance disorder, decreased quality of life.
However, there are no studies evaluating the body structure, function, activity and participation of immunodeficiency patients within the scope of ICF. Our study has the feature of being the first study in which immunodeficiency patients were evaluated within the scope of ICF. With this study, the investigators believe that a holistic assessment conducted within the framework of ICF in immunodeficiency patients will have a positive impact on the clinical decision-making process of cardiopulmonary rehabilitation professionals. This study aims; to evaluate the body structure function, activity and participation limitations of adult immunodeficiency patients within the scope of ICF and to compare with healthy people. A second goal is to evaluate the relationships between body structure, function, activity and participation limitations in adult immune deficiency patients.
- Keywords
- Primary Immune Deficiency, ICF, Functional Performance
- Medical subject headings
- Primary Immunodeficiency Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Primary Immune Deficiency | Patients between the ages of 18-65 years who have been diagnosed with primary immunodeficiency | |
| Healthy Controls | Age and sex matched healthy controls between the ages of 18-65 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of hand grip strength
The participants will be measured in an unsupported sitting position with his back upright, while the elbow is in flexion (the person's arm is adjacent to the torso, in a neutral position, and the elbow is in a 90° flexion, with the wrist neutral). The measurements for the dominant and non-dominant sides will be repeated three times. The average of the three measurements for each side will be taken and recorded in Newton (N).
Measured: 1 day
Secondary outcomes (10)
Evaluation of body composition:
The bioelectric impedance analysis (XIAOMI MI 2 Body Analysis Scale)
Measured: 1 day
Comorbidity Assessment
The Charlson Comorbidity Index developed by Charlson et al. will be used to determine the short-term mortality risk of patients with concomitant disease conditions. DM 1 point without myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disorder, peptic ulcer disease, mild liver disease and end-organ damage on the scale; hemiplegia, moderate and severe kidney disease, DM with end-organ damage, non-metastatic tumor, leukemia, lymphoma and myeloma are 2 points; 3 points for moderate or severe liver disease; and metastatic solid tumor or Acquired Immune Deficiency Syndrome (Acquired Immune Deficiency Syndrome -AIDS) is 6 points. The total score, on the other hand, will be calculated by adding up the equivalent scores of diseases.
Measured: 1 day
Evaluation of Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI), which has Turkish validity and reliability and evaluates an individual's sleep quality for the last one month, contains a total of 24 questions. 19 Of these questions are answered by the patient himself, he participates in the scoring. 5 questions are answered by the patient's spouse or roommate and are used only for clinical information and do not participate in scoring. Each question is evaluated with a score between 0-3.Dec. The total PSQI score takes a value between 0-21.Dec. In the end, 7 components are calculated. These; subjective sleep quality is sleep latency, sleep duration, habitual sleep efficiency, sleep disorder, sleeping medication use, daytime dysfunction. The total PSQI score is obtained by summing the scores of all these components. Those with a total score of 5 and below 5 are rated as having "good" sleep quality, and those with a total score of over 5 are rated as "poor" sleep quality.
Measured: 1 day
Fatigue Assessment
The severity of fatigue in the daily life of the patients was evaluated with the Fatigue Severity Scale (FSS), which has validity and reliability in Turkish. Patients can apply this scale, which has nine items, on their own. The patient is informed about how to fill out the scale, but patients are not guided for questions and statements that they have difficulty understanding. Patients are asked to choose a score from 1 to 7, which indicates how much they agree with each statement on the scale. Statements related to scoring; 1. I Strongly Disagree, 2. Disagree, 3. I Tend to Disagree, 4: I am Undecided, 5: I Tend to Agree, 6: I Agree, 7: I Strongly Agree. Scores of 4 and above given to the statements indicate that fatigue is severe.
Measured: 1 day
Posture Evaluation
The posture analysis form developed by Corbin and his colleagues was used to determine the postural disorders of the patients. The analysis will be evaluated in two different ways, posterior and lateral. According to the scoring of the results of the posture analyses according to their severity, they will be rated as 0: none, 1: light, 2: moderate and 3: severe. According to the total lateral and posterior posture score, the total score varies between 0-12. Dec.
Measured: 1 day
Evaluation of Quality of Life
To evaluate the quality of life, Koçyiğit et al. the SF-36 quality of life scale, which has been validated by our country, will be applied. SF-36 Quality of Life consists of eight subgroups: physical function, physical role restriction, emotional role restriction, body pain, social function, mental health, vitality, general health and contains a total of 36 questions. Scoring is made between 0-100 for each group. The lowest score indicates the worst state of health. The last four weeks of the patients' conditions will be taken into account in the evaluation.
Measured: 1 day
Evaluation of Daily Living Activities
To evaluate daily living activities, Işık et al. The Lawton Instrumental Daily Living Activities (IADL) scale, which has been made a validity study for our country, will be applied. The Lawton Instrumental Daily Living Activities (IADL) scale consists of eight categories: the ability to use a phone, shopping, food preparation, household chores, laundry, transportation method, responsibility for using one's medicines and the ability to manage financial affairs. The responses given to each of the eight categories on the scale are coded as 0 (can't or partially can) or 1 (can), and the responses are summed. The total score varies between 0 (low-functioning, dependent) and 8 December (high-functioning, independent).
Measured: 1 day
Evaluation of Physical Activity
The International Physical Activity Questionnaire (IPAQ) long form, which has validity and reliability in Turkish, will be used to determine the level of physical activity by questioning the activities within the last 7 days. It includes the sum of the duration (how many minutes per day) and frequency (how many days in the last 7 days) to calculate the total score. The total score can be calculated with two different evaluations. The first includes special scoring (work, transportation, home gardening, leisure time), and the second includes activity-specific scoring (walking, moderate-intensity activity, vigorous activity). In activity-specific scoring, walking, moderate violent activity and violent activity under their heading of the sections are Decoupled by the sum between them. With these calculations, a value is found in MET-minutes. A MET-minute is calculated by multiplying the MET score by the minute of the activity performed.
Measured: 7 day
Exercise Capacity Assessment
It is a simple, applicable alternative test to 6 DYT that evaluates exercise capacity, whose reliability has been proven in various lung diseases such as Cystic Fibrosis and COPD. The patient, whose height is 44 cm, who is sitting in a chair without armbands and has a place to recline, is asked to cross his arms to chest level. The patient, who is standing upright with his hips and knees coming to full flexion, sits down again. the number of repetitions of the patient who does sit-up for 1 minute will be recorded. In the interpretation of the test, the reference values determined by age will be taken as a basis and expressed as a percentage of the expected values. In addition, heart rate, oxygen saturation, dyspnea and leg fatigue values will be recorded before and after the test.
Measured: 1 day
Evaluation of ICF Parameters
ICF belongs to the international classification "family" developed by the World Health Organization (WHO) for application in many areas of health. It uses a standard, common language that enables worldwide communication related to health and medical care in various disciplines and scientific fields. In order to evaluate disorders, activity limitations and limitations in participation, the subparagraphs of area b (body functions), area s (body structures), area d (activity and participation level) and area e (environmental and personal factors) will be comprehensively scanned to select items related to the classification area. Scoring is done separately for each item in the body structures (s), body functions (b), activity and participation (d), environmental and personal factors section. In this study, a Decrement between 0-4 will be made for each item in all sections. Items or sections with a higher score indicate more affect/disorder.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start15 Mar 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ebru Calik-Kutukcu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014463
- Sponsor's protocol ID
- GO 23/16
- Status last verified
- Feb 2024
- First submitted
- 18 Aug 2023
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adult Patients With Immunodeficiency Within the Scope of the International Classification of Functionality, Ability and Health
- ClinicalTrials.gov ID
- NCT06014463
- Acronym / sponsor ID
- GO 23/16
- Keywords
- Primary Immune Deficiency, ICF, Functional Performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 28 Aug 2023 (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.
Primary immunodeficiency is a clinically, immunologically, and genetically heterogeneous group of diseases that occur as a result of quantitative and/or qualitative deficiency of one or more cellular and molecular components belonging to the immune system. This classification, called the International Classification of Functioning, Disability and Health ( ICF), constitutes a common language and perspective for the definition of health and health-related conditions. This study aimed to evaluate the body structure function, activity and participation limitations of adult immunodeficiency patients within the scope of ICF and to compare body structure function, activity and participation limitations and compare with healthy people.
Detailed description
Primary immunodeficiency is a clinically, immunologically and genetically heterogeneous group of diseases that occur as a result of quantitative and/or qualitative deficiency of one or more cellular and molecular components belonging to the immune system. The overall prevalence of PID in the world is stated as 1/2,000-1/10,000 per live birth. In our country, the national PID registration system has just been established. It is estimated that this rate is higher in developing countries such as Turkey, where there is a lot of inbreeding. The clinical appearance of PID is highly variable; however, most often it is characterized by an increased predisposition to infection. Therefore, the disease manifests itself with infections that are "recurrent and difficult to respond to treatment". PID, which mostly starts to give symptoms in childhood, are in the category of rare diseases. For this reason, the probability of receiving a diagnosis in primary and second-line healthcare institutions is very low. Since the course of the disease is poor in a significant part of PID, early diagnosis and timely treatment are very important for reducing mortality, morbidity and economic burden. This is possible with the level of social awareness and the high index of suspicion of medical personnel. For the successful management of the disease, the patient should be quickly referred to a clinical immunologist experienced in immunodeficiencies and further tests should be performed. Fifteen years ago, the Jeffrey Modell Foundation (JMF) identified clinical signs that arouse suspicion of PID in children and adults. This document is a useful basis, but revision is required because it does not take into account the autoimmune, inflammatory or malignant manifestations of PID, which may be the cause of the main clinical presentation in some of the PID. Pulmonary complications are common in PID and contribute significantly to the morbidity and mortality of patients. Recurrent respiratory infections (more than 2 per year for children and within 3 years for adults) are one of the 10 warning signs of PİY recommended by the Jeffrey Modell Foundation and are often the cause of death in adults with PID. Especially in PID, which is characterized by antibody deficiency, frequent recurrent upper and lower respiratory tract infections lead to chronic complications in tissues and organs. Bronchiectasis is the prominent one among these. According to the European Society of Immunodeficiencies, bronchiectasis develops in ~23% of patients with NDI (one-third of all PID patients) . It has been shown that the general state of health, psychosocial well-being level and quality of life are low in patients with PI who have developed chronic lung disease, and it has been found that their daily activities are significantly limited.
This classification, called the International Classification of Functioning, Disability and Health (ICF), was developed in 2000 to create a common language and perspective for the definition of health and health-related conditions. Objectives of the ICF classification:
- To create a scientifically based approach to determine health and health-related conditions
- To facilitate and increase communication between all health professionals and individuals in different professional groups and to ensure the formation of a common language Dec
- To ensure the determination of health-related applications
- Coding health-related factors with a specific system ICF provides the functional status of individuals and the identification of problems that they may encounter in daily life from a biopsychosocial point of view.
ICF-CY evaluates health-related situations with a total of 1685 items in 4 sections. The fact that it has so much substance constitutes a disadvantage in terms of its use. For this reason, with the ICF Core Sets Project study in 2003, disease-specific core sets were created by selecting categories that are specific to diseases and can fully identify the patient. Core sets, just like ICF, treat the patient holistically. Each set has 2 separate forms in the form of short form and long form. There are 5 core sets that can evaluate cardiopulmonary system disorders. Cardiopulmonary disorders, obesity, diabetes mellitus, COPD, chronic ischemic heart problems are the core sets. In a study conducted on 40 pediatric patients with and without cystic fibrosis, it was shown that the ICF model is applicable and useful in evaluating body function and structure disorders such as November muscle weakness, postural anomalies, and limitations in activity and participation in daily life, and in creating a treatment plan. a study conducted on 24 lung transplant patients showed that the ICF model is practical and applicable in the clinic for evaluating activity and participation restrictions such as decreased exercise capacity, body structure and function disorders such as postural disorders, physical activity in daily life, balance disorder, decreased quality of life.
However, there are no studies evaluating the body structure, function, activity and participation of immunodeficiency patients within the scope of ICF. Our study has the feature of being the first study in which immunodeficiency patients were evaluated within the scope of ICF. With this study, the investigators believe that a holistic assessment conducted within the framework of ICF in immunodeficiency patients will have a positive impact on the clinical decision-making process of cardiopulmonary rehabilitation professionals. This study aims; to evaluate the body structure function, activity and participation limitations of adult immunodeficiency patients within the scope of ICF and to compare with healthy people. A second goal is to evaluate the relationships between body structure, function, activity and participation limitations in adult immune deficiency patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Primary Immune Deficiency | – | –Patients between the ages of 18-65 years who have been diagnosed with primary immunodeficiency |
| Healthy Controls | – | –Age and sex matched healthy controls between the ages of 18-65 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-65 who have been diagnosed with immunodeficiency at Başkent University Hospital Immunology Department and Gülhane Hospital Immunology Department and who are willing to participate in the research and 18-65 patients who are diagnosed with immunodeficiency will be accepted for the study. The snowball sampling method will be used for our control group. We plan to contact the patient's relatives and then contact someone else in the same way. At the same time, we plan to prepare a text explaining each method and reach people through social media.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of hand grip strength
Time frame: 1 day
The participants will be measured in an unsupported sitting position with his back upright, while the elbow is in flexion (the person's arm is adjacent to the torso, in a neutral position, and the elbow is in a 90° flexion, with the wrist neutral). The measurements for the dominant and non-dominant sides will be repeated three times. The average of the three measurements for each side will be taken and recorded in Newton (N).
10 secondary outcomes
Evaluation of body composition:
Time frame: 1 day
Comorbidity Assessment
Time frame: 1 day
Evaluation of Sleep Quality
Time frame: 1 day
Fatigue Assessment
Time frame: 1 day
Posture Evaluation
Time frame: 1 day
Evaluation of Quality of Life
Time frame: 1 day
Evaluation of Daily Living Activities
Time frame: 1 day
Evaluation of Physical Activity
Time frame: 7 day
Exercise Capacity Assessment
Time frame: 1 day
Evaluation of ICF Parameters
Time frame: 1 day
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 28 Feb 2024.
- 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.
Ebru Calik-Kutukcu, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immune Deficiency and Exercise Capacity, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Feb 2024. 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 Turkey (Türkiye). 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?
Evaluation of hand grip strength (time frame: 1 day). 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 28 Feb 2024.