The Effect of Exercise Training and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure

August 6, 2025 updated by: Evangelia Kouidi, Aristotle University Of Thessaloniki

The Effect of Exercise Training Intervention and Detraining on Frailty and Fall Risk in Patients With Chronic Heart Failure.

Chronic Heart Failure (CHF) is the endpoint for some cardiac and respiratory conditions as well as ageing affecting 1-2% of the global adult population. CHF requires a costly treatment, frequent hospitalizations due its severe complications leading CHF eventually to a frequent cause of morbidity and mortality worldwide. Another common complication of CHF is frailty. Frailty is a complex clinical syndrome associated with CHF, resulting from multiple organ impairment; physiological reserves decrease and vulnerability to stressors increase. Up to 79% of PwCHF are frail leading to reduced functional capacity, quality of life (QoL), and psychological well-being in CHF, and it is an independent predictor of mortality in cardiovascular disease.

The role of cardiac rehabilitation (CR) programs for PwCHF in preventing frailty has recently draw the attention of the scientific world. Exercise constitutes a unique effective and feasible non-pharmacological treatment for frailty in CHF as it offers such benefits that are irreplaceable by medical treatment, with no side effects, and cost-effective treatment. However, there are no studies examining the effect of training and detraining on muscle strength and balance, fall prevention and fear of falling in PwCHF.

The aim of this randomized controlled trial is to examine whether a 6-month combined aerobic, strengthening and flexibility-mobility CR program and a 3-month de-training period will affect frailty and fall risk in PwCHF. One hundred participants will be randomly allocated into two groups: Group A (Exercise Group) will receive 3 sessions per week for 6 months and Group B(Control Group) will continue their usual physical activity, without participating in organized exercise programs.After the intervention for Group A' will follow a 3- month de-training period and Group B' will continue their normal physical activity. Prior to the group random allocation, part of our assessments at baseline and after 6 (Evaluation A') and 10 months (Evaluation B'), will include demographics and clinical history, physical examination, ECG and echocardiogram, patients' ability to perform daily activities, functional tests, static balance tests, body composition analysis and 24-h heart rhythm holter monitoring. Moreover, we will use questionnaires assessing the QoL of people with CHF, depression, anxiety, sleep quality, cognitive function, fear of falling, physical activity, and sedentary behaviour.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Greece
    • Thermi
      • Thessaloniki, Thermi, Greece, 57001
        • Recruiting
        • Sports Medicine Laboratory, Aristotle University of Thessaloniki
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18 yrs. of either gender
  • Confirmed diagnosis (by echocardiography) of HF reduced or preserved left ventricular ejection fraction (HFrEF/ΗFpEF)
  • Symptomatic New York Heart Association (NYHA) class II-III

Exclusion Criteria:

  • Acute Myocardial Infarction (<4 weeks)
  • Severe valvular diseases
  • Potentially malignant arrhythmias
  • Νeurological, or orthopedic limitations/non- ambulant status
  • Cognitive disorders
  • Poor regulation of comorbidities
  • Already participating in organized exercise programs
  • Current pregnancy
  • NYHA function class IV
  • Inability/unwillingness to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Group B
Control Group, 10- month normal physical activity, without participating in organized sports activities, no intervention
Experimental: Group A
Exercise Group, 6- month combined aerobic, strengthening, mobility- flexibility exercise intervention, 3- month de-training period
Other: Exercise Intervention
Patients that will be randomly assigned to this group will be invited to attend up to 72 exercise sessions (3 sessions per week) for 24 weeks (6 months) following a combined aerobic, strengthening and mobility-flexibility exercise program. After the exercise intervention, the will follow a 3-month de-training period, continuing their normal physical activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Left Ventricular Systolic Function
Time Frame: Baseline
Evaluation of Left Ventricular Ejection Fraction
Baseline
Left Ventricular Systolic Function
Time Frame: Evaluation A', 6- months
Evaluation of Left Ventricular Ejection Fraction
Evaluation A', 6- months
Cardiac Autonomic Nervous System Function
Time Frame: Baseline
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Baseline
Cardiac Autonomic Nervous System Function
Time Frame: Evaluation A', 6- months
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Evaluation A', 6- months
Body Composition Analysis
Time Frame: Baseline
Evaluation of Body Composition Analysis
Baseline
Six- Minute Walking Test
Time Frame: Baseline
Estimation of aerobic capacity through six minutes walking test
Baseline
Six- Minute Walking Test
Time Frame: Evaluation A', 6- months
Estimation of aerobic capacity through six minutes walking test
Evaluation A', 6- months
Timed- Up-and-Go Test
Time Frame: Baseline
Evaluation of functional capacity using Timed- Up-and-Go Test
Baseline
Timed- Up-and-Go Test
Time Frame: Evaluation A', 6- months
Evaluation of functional capacity using Timed- Up-and-Go Test
Evaluation A', 6- months
Handgrip Strength
Time Frame: Baseline
Evaluation of Handgrip Strength
Baseline
Handgrip Strength
Time Frame: Evaluation A', 6- months
Evaluation of Handgrip Strength
Evaluation A', 6- months
Isometric Pulling in a Semi-Squat Position
Time Frame: Baseline
Evaluation of Isometric Pulling in a Semi-Squat Position
Baseline
Isometric Pulling in a Semi-Squat Position
Time Frame: Evaluation A', 6- months
Evaluation of Isometric Pulling in a Semi-Squat Position
Evaluation A', 6- months
30- second Arm Curl Test
Time Frame: Baseline
Evaluation using Arm Curl Test
Baseline
30- second Arm Curl Test
Time Frame: Evaluation A', 6- months
Evaluation using Arm Curl Test
Evaluation A', 6- months
Sit-and-Reach Test
Time Frame: Baseline
Evaluation of mobility-flexibility using Sit-and-Reach Test
Baseline
Sit-and-Reach Test
Time Frame: Evaluation A', 6- months
Evaluation of mobility-flexibility using Sit-and-Reach Test
Evaluation A', 6- months
Back Scratch Test
Time Frame: Baseline
Evaluation of mobility using Back Scratch Test
Baseline
Back Scratch Test
Time Frame: Evaluation A', 6- months
Evaluation of mobility using Back Scratch Test
Evaluation A', 6- months
Falls Efficacy Scale (FES-I)
Time Frame: Evaluation A', 6- months
Evaluation of fear of falling using Falls Efficacy Scale
Evaluation A', 6- months
Evaluation of Physical Activity and Sleep Quality using a wearable device
Time Frame: Baseline
Evaluation of Physical Activity and Sleep Quality using a wearable device
Baseline
Evaluation of Physical Activity and Sleep Quality using a wearable device
Time Frame: Evaluation A', 6- months
Evaluation of Physical Activity and Sleep Quality using a wearable device
Evaluation A', 6- months
4m-Walking Test
Time Frame: Baseline
Evaluation of functional capacity and mobility using 4m-Walking Test
Baseline
4m-Walking Test
Time Frame: Evaluation A', 6- months
Evaluation of functional capacity and mobility using 4m-Walking Test
Evaluation A', 6- months
30-second Sit-to-Stand (STS)Test
Time Frame: Baseline
Evaluation of functional capacity and mobility using 30-second STS
Baseline
30-second Sit-to-Stand (STS)Test
Time Frame: Evaluation A', 6- months
Evaluation of functional capacity and mobility using 30-second STS
Evaluation A', 6- months
5 Sit-to-Stand (5-STS)Test
Time Frame: Baseline
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Baseline
5 Sit-to-Stand (5-STS)Test
Time Frame: Evaluation A', 6- months
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Evaluation A', 6- months
mini-BEST Balance Test
Time Frame: Baseline
Evaluation of balance using mini-BEST Balance Test
Baseline
mini-BEST Balance Test
Time Frame: Evaluation A', 6- months
Evaluation of balance using mini-BEST Balance Test
Evaluation A', 6- months
Berg Balance Scale Test
Time Frame: Baseline
Evaluation of balance using Berg Balance Scale Test
Baseline
Berg Balance Scale Test
Time Frame: Evaluation A', 6- months
Evaluation of balance using Berg Balance Scale Test
Evaluation A', 6- months
Functional Gait Assessment Test
Time Frame: Baseline
Evaluation of Functional Gait using Functional Gait Assessement Test
Baseline
Functional Gait Assessment Test
Time Frame: Evaluation A', 6- months
Evaluation of Functional Gait using Functional Gait Assessement Test
Evaluation A', 6- months
Static Balance Test using 3D Balance Force Plate
Time Frame: Baseline
Evaluation of Static Balance Test using 3D Balance Force Plate
Baseline
Static Balance Test using 3D Balance Force Plate
Time Frame: Evaluation A', 6- months
Evaluation of Static Balance Test using 3D Balance Force Plate
Evaluation A', 6- months
Strength of Upper and Lower Extremities
Time Frame: Baseline
Evaluation of Strength of Upper and Lower Extremities
Baseline
Strength of Upper and Lower Extremities
Time Frame: Evaluation A', 6- months
Evaluation of Strength of Upper and Lower Extremities
Evaluation A', 6- months
Fear of Falling and Activity Restriction (SAFE)
Time Frame: Baseline
Assessement of Fear of Falling and Activity Restriction (SAFE)
Baseline
Left Ventricular Systolic Function
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of Left Ventricular Ejection Fraction
Evaluation B', 3 months after evaluation A'
Cardiac Autonomic Nervous System Function
Time Frame: Evaluation B', 3 months
Evaluation of Cardiac Autonomic Nervous System Function through 24-h Heart Rhythm Holter Monitor measurement
Evaluation B', 3 months
Body Composition Analysis
Time Frame: Evaluation A', 3- months
Evaluation of Body Composition Analysis
Evaluation A', 3- months
Body Composition Analysis
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of Body Composition Analysis
Evaluation B', 3 months after evaluation A'
Six- Minute Walking Test
Time Frame: Evaluation B', 3 months after evaluation A'
Estimation of aerobic capacity through six minutes walking test
Evaluation B', 3 months after evaluation A'
Timed- Up-and-Go Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using Timed- Up-and-Go Test
Evaluation B', 3 months after evaluation A'
4m-Walking Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 4m-Walking Test
Evaluation B', 3 months after evaluation A'
30-second Sit-to-Stand (STS)Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 30-second STS
Evaluation B', 3 months after evaluation A'
5 Sit-to-Stand (5-STS)Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of functional capacity and mobility using 5 Sit-to-Stand
Evaluation B', 3 months after evaluation A'
mini-BEST Balance Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of balance using mini-BEST Balance Test
Evaluation B', 3 months after evaluation A'
Berg Balance Scale Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of balance using Berg Balance Scale Test
Evaluation B', 3 months after evaluation A'
Functional Gait Assessment Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of Functional Gait using Functional Gait Assessement Test
Evaluation B', 3 months after evaluation A'
Static Balance Test using 3D Balance Force Plate
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of Static Balance Test using 3D Balance Force Plate
Evaluation B', 3 months after evaluation A'
Handgrip Strength
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of Handgrip Strength
Evaluation B', 3 months after evaluation A'
Strength of Upper and Lower Extremities
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of Strength of Upper and Lower Extremities
Evaluation B', 3 months after evaluation A'
Isometric Pulling in a Semi-Squat Position
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of Isometric Pulling in a Semi-Squat Position
Evaluation B', 3 months after evaluation A'
30- second Arm Curl Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation using Arm Curl Test
Evaluation B', 3 months after evaluation A'
Sit-and-Reach Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of mobility-flexibility using Sit-and-Reach Test
Evaluation B', 3 months after evaluation A'
Back Scratch Test
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of mobility using Back Scratch Test
Evaluation B', 3 months after evaluation A'
Evaluation of Physical Activity and Sleep Quality using a wearable device
Time Frame: Evaluation B', 3 months after evaluation A'
Evaluation of Physical Activity and Sleep Quality using a wearable device
Evaluation B', 3 months after evaluation A'
SF-36
Time Frame: Baseline
Assessment of Quality of Life using SF-36
Baseline
SF-36
Time Frame: Evaluation A', 6- months
Assessment of Quality of Life using SF-36
Evaluation A', 6- months
SF-36
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Quality of Life using SF-36
Evaluation B', 3 months after evaluation A'
I-PAQ
Time Frame: Baseline
Assessment of Physical Activity using I-PAQ
Baseline
I-PAQ
Time Frame: Evaluation A', 6- months
Assessment of Physical Activity using I-PAQ
Evaluation A', 6- months
I-PAQ
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Physical Activity using I-PAQ
Evaluation B', 3 months after evaluation A'
Beck Depression Inventory
Time Frame: Baseline
Assessment of Depression using Beck Depression Inventory
Baseline
Beck Depression Inventory
Time Frame: Evaluation A', 6- months
Assessment of Depression using Beck Depression Inventory
Evaluation A', 6- months
Beck Depression Inventory
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Depression using Beck Depression Inventory
Evaluation B', 3 months after evaluation A'
Falls Efficacy Scale (FES-I)
Time Frame: Baseline
Assessment of fear of falling using Falls Efficacy Scale
Baseline
Falls Efficacy Scale (FES-I)
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of fear of falling using Falls Efficacy Scale
Evaluation B', 3 months after evaluation A'
Activities-specific Balance Confidence (ABC) Scale
Time Frame: Baseline
Assessment of Balance Confidence using ABC
Baseline
Activities-specific Balance Confidence (ABC) Scale
Time Frame: Evaluation A', 6- months
Assessment of Balance Confidence using ABC
Evaluation A', 6- months
Activities-specific Balance Confidence (ABC) Scale
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Balance Confidence using ABC
Evaluation B', 3 months after evaluation A'
Minnesota Living with Heart Failure (MLHFQ)
Time Frame: Baseline
Assessment of health-related quality of life using MLHFQ
Baseline
Minnesota Living with Heart Failure (MLHFQ)
Time Frame: Evaluation A', 6- months
Assessment of health-related quality of life using MLHFQ
Evaluation A', 6- months
Minnesota Living with Heart Failure (MLHFQ)
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of health-related quality of life using MLHFQ
Evaluation B', 3 months after evaluation A'
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline
Assessment of Sleep Quality using PSQI
Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Evaluation A', 6- months
Assessment of Sleep Quality using PSQI
Evaluation A', 6- months
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Sleep Quality using PSQI
Evaluation B', 3 months after evaluation A'
Intrinsic Motivation Inventory (IMI)
Time Frame: Baseline
Assessment of Intrinsic Motivation using IMI
Baseline
Intrinsic Motivation Inventory (IMI)
Time Frame: Evaluation A', 6- months
Assessment of Intrinsic Motivation using IMI
Evaluation A', 6- months
Intrinsic Motivation Inventory (IMI)
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Intrinsic Motivation using IMI
Evaluation B', 3 months after evaluation A'
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Time Frame: Baseline
Assessment of Depression and Anxiety using HRSD and HARS
Baseline
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Time Frame: Evaluation A', 6- months
Assessment of Depression and Anxiety using HRSD and HARS
Evaluation A', 6- months
Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale (HARS)
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Depression and Anxiety using HRSD and HARS
Evaluation B', 3 months after evaluation A'
Montreal Cognitive Assessment Test (MOCA)
Time Frame: Baseline
Assessment of cognitive function using MOCA
Baseline
Montreal Cognitive Assessment Test (MOCA)
Time Frame: Evaluation A', 6- months
Assessment of cognitive function using MOCA
Evaluation A', 6- months
Montreal Cognitive Assessment Test (MOCA)
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of cognitive function using MOCA
Evaluation B', 3 months after evaluation A'
Falls
Time Frame: Baseline
Assessment of the number of weekly falls
Baseline
Falls
Time Frame: Evaluation A', 6- months
Assessment of the number of weekly falls
Evaluation A', 6- months
Falls
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of the number of weekly falls
Evaluation B', 3 months after evaluation A'
Foot Preference Questionnaire (FPQ)
Time Frame: Baseline
Assessment of Foot Preference during static balance or activities using FPQ
Baseline
Foot Preference Questionnaire (FPQ)
Time Frame: Evaluation A', 6- months
Assessment of Foot Preference during static balance or activities using FPQ
Evaluation A', 6- months
Foot Preference Questionnaire (FPQ)
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Foot Preference during static balance or activities using FPQ
Evaluation B', 3 months after evaluation A'
Fear of Falling and Activity Restriction (SAFE)
Time Frame: Evaluation A', 6- months
Assessment of Fear of Falling and Activity Restriction (SAFE)
Evaluation A', 6- months
Fear of Falling and Activity Restriction (SAFE)
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of Fear of Falling and Activity Restriction (SAFE)
Evaluation B', 3 months after evaluation A'
Trail Making Test
Time Frame: Baseline
Assessment of visual attention and task switching using Trail Making Test
Baseline
Trail Making Test
Time Frame: Evaluation A', 6- months
Assessment of visual attention and task switching using Trail Making Test
Evaluation A', 6- months
Trail Making Test
Time Frame: Evaluation B', 3 months after evaluation A'
Assessment of visual attention and task switching using Trail Making Test
Evaluation B', 3 months after evaluation A'

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Evangelia Kouidi, Professor, Director of Sports Medicine Laboratory, Aristotle University of Thessaloniki, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 110/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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