Chronic Heart FailureNCT05230927
Cognitive Impairment, Frailty and Rehabilitative Outcome in Older Patients Affected by Cardiorespiratory Disease
An observational study of Chronic Heart Failure and Chronic Obstructive Pulmonary Disease, run by Antonia Pierobon at 1 site in Italy.
Trial summary
A consistent number of studies in the last few years highlighted that the functional and clinical worsening in patients with cardiac and/or respiratory disease/s increase the risk of cognitive decline. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Multidisciplinary Rehabilitation
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2020to 23 Dec 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: CHF was defined as: I) signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral edema) and symptoms of HF [New York Heart Association (NYHA) functional class II-IV] in the presence of reduced ejection fraction (LVEF <40%); or II) signs and symptoms of HF (e.g. elevated brain natriuretic peptides and significant structural heart disease/diastolic dysfunction) with mid-range ejection fraction (LVEF 40-49%) or preserved (LVEF ≥50%). Patients were diagnosed according to Global initiative for chronic Obstructive Lung Disease (GOLD) criteria (Stage II-IV, C-D); they were in clinically stable condition (no exacerbations in the last 3 months) with optimized stable pharmacological therapy (inhalation therapy with long-acting anticholinergic and/or β2-agonists, inhaled corticosteroids when needed).
Who may be able to join
- All inpatients admitted to the Cardiac Rehabilitation Department and the Pulmonary Rehabilitation Department of ICS Maugeri - Tradate (Varese) and Montescano (Pavia) affected by CHF or COPD.
Who cannot join
- severe clinical conditions (chronic inflammatory diseases, neoplasia)
- psychiatric and neurological conditions(at anamnestic or actual clinical evaluation),
- no Italian education, illiteracy or relapse into illiteracy,
- severe visuo-perceptive deficits,
- lack of motivation or refusal to undergo the evaluation,
- severe cognitive deterioration (Mini-Mental State Examination - MMSE score <18.3)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Impairment, Frailty and Rehabilitative Outcome in Older Patients Affected by Cardiorespiratory Disease (DEC_FRAinRIAB)
A consistent number of studies in the last few years highlighted that the functional and clinical worsening in patients with cardiac and/or respiratory disease/s increase the risk of cognitive decline.
The literature reports a greater diffusion of screening procedures for cognitive deficits in patients with cardiac diseases compared to patients with respiratory diseases. However, in both populations, the interest for cognitive impairment is justified by multiple reasons: the numerous exacerbations of the disease and re-hospitalizations, the difficulty in following complex therapeutic regimens and recognizing worsening of symptoms, the reduced functional autonomy and the rehabilitation outcome . Although recently the Italian Society of Geriatrics and Gerontology has raised the threshold for the definition of the 'elderly' patient from 65 to 75 years to better adapt to the current physical and mental performance of men and women living in economically developed countries and to the demographic situation of the Italian population. Therefore the three classes of 'elderly' patients that we will enroll will be defined as follows: "young old" (65-74 years), "old" (75-84 years), and "old-old" (≥85 years). In general, the age of the eligible sample is defined as ≥ 65 years.
Read more
Furthermore, in chronic diseases, emotional factors, such as anxiety and depression, also play an important role in disease adaptation and in the rehabilitation outcome in both cardiac and respiratory diseases.
Alongside the problems relating to emotional aspects and cognitive decline, the frailty syndrome is noteworthy, particularly in the elderly and in the presence of cardiac/respiratory diseases. Frailty is associated with the loss of functionality that leads to greater vulnerability to adverse events such as the increased risk of falls, hospitalization, institutionalization, disability and mortality.
Frailty screening or assessment scales provide predictive information on the risk of death and institutionalization and they are a good predictor of acute hospital outcomes too. Instead, concerning what emerges from international literature, in rehabilitation cardiology, despite the increase in the presence of elderly patients, the clinical and prognostic relevance of frailty has not yet been well defined and measured. On the other hand, recent studies points out that frailty is present in 1/4 of outpatient COPD patients, it is an independent predictor of rehabilitation program interruption and it is also easily reversible in the short term after rehabilitation, thus frailty appears to be one of the relevant aspects in rehabilitative treatment.
In light of the data in the literature, the purposes of this prospective observational study are to evaluate the following objectives:
- At baseline, the presence of cognitive impairment, anxiety, depression, the assessment of self-reported adherence to therapeutic prescriptions and frailty in a sample of elderly patients (age ≥65) with chronic cardiorespiratory disease admitted for a cardiorespiratory rehabilitation cycle and the correlation with disease severity and functional aspects.
- In follow-up, the impact that these factors have on the rehabilitation outcome at the end of hospitalization and on the state of health at six months (telephone interview).
- Being tested
- Multidisciplinary Rehabilitation
- 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.
Multidisciplinary RehabilitationOther
All patients admitted to an inpatient rehabilitation program will undergo medical history collection, physical, clinical, and functional examination, exercise testing, educational sessions, exercise training (cycle ergometer/treadmill, arm ergometer, breathing, and strength exercises where indicated, calisthenics exercises), psychological counseling, and metabolic evaluation with a personalized diet when needed.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Heart Failure | Not described Receives: Other: Multidisciplinary Rehabilitation | |
| Chronic Obstructive Pulmonary Disease | Not described Receives: Other: Multidisciplinary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cognitive status
Addenbrooke's Cognitive Examination III (ACE III) is a 20 minutes screening test, designed for the early detection of cognitive deterioration. It provides a score from 0 to 100 and it analyzes the following five cognitive domains: Attention-Orientation (ACE III-AO = 0-18), Memory (ACE III-M 0 0-26), Verbal Fluency (ACE III-VF = 0-14), Language (ACE III-L = 0-26), and Visuospatial abilities (ACE III-VS = 0-16).
Frontal Assessment Battery (FAB) is a neuropsychological screening test used to assess executive functions. It is a quick and easy test to administer, its score ranges from 0 to 18, and it is divided into the following six sub-tests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental dependency.
Measured: evaluation performed at patient's admission and before discharge (approximately 20 days)
Changes in Health-related Quality of Life
The EQ-5D-5L is a generic quality of life measurement tool. It investigates the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has five levels: 1, no problem; 2, slight problem; 3 moderate problem; 4 severe problem; 5 extreme problem. The second section consists of a Visual Analogue Scale (VAS) from 0 (Worst imaginable health state) to 100 (Best imaginable health state), where the subject is asked to indicate the level of self-perceived wellness.
Measured: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
Changes in psychological characteristics
Patient Health Questionnaire-9 (PHQ-9) is a scale used to determine the diagnosis, severity, and subsequent monitoring of depressive illnesses of the patient. It is divided into nine sub-items, to identify depressive symptoms within the last two weeks (following DSM criteria). The final score has a range between 0-27 and it is divided into clinical variability ranges according to a continuum of symptom severity, where scores of 5, 10, 14, and 19 are considered cut-offs for subthreshold, mild major, moderate major, and severe major depression.
Generalized Anxiety Disorder-7 (GAD) is a questionnaire built to measure the severity of anxiety symptoms in the previous two weeks. The questionnaire consists of 7 items and it organizes the severity of the responses on a 4-point Likert scale. The range scores range from 0 to 21, where scores of 5, 10, and 15 are considered cut-offs for mild, moderate, and severe anxiety, respectively.
Measured: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
Changes in self-reported adherence
The Antecedents and Self-efficacy on Adherence Schedule (ASonA) is a self- report schedule aimed to evaluate cognitive, behavioral, and emotional determinants of pharmacological and non-pharmacological adherence. It is a 21-item schedule scored on a 5-point Likert scale (0=not at all, 4=very much). The schedule comprises 3 subscales: Antecedents (ASonA-A), which include health condition and health-related limitations acceptance, social support and knowledge about health condition; Self- efficacy (ASonA-SE), exploring patients' self-care strategies, and patients' ability to adhere to medication assumption and to non-pharmacological recommendations (i.e., physical activity, diet, alcohol consumption, and smoking avoidance); and Affectivity (ASonA-Aff) which measures patients' emotional aspects in relation to the health condition.
Measured: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
Frailty evaluation
Frailty Index (FI) is a frailty measurement tool created through a geriatric assessment study including non-institutionalized patients. The variables taken into consideration are mobility, muscle strength, comorbidities, cognitive deficits, mood, anthropometric indices, mini nutritional assessment, and social support. It is made up of 40 items and 17 additional items relating to the Social Support Scale.
Measured: evaluation performed at patient's admission
Changes in frailty status
Clinical Frailty Scale (CFS) is a scale developed in Canada, which is based on clinical judgment only with a score ranging from 1 to 9: 1) Very Fit; 2) Well; 3) Managing Well; 4) Vulnerable; 5) Mildly Frail; 6) Moderately; Frail; 7) Severely frail; 8) Very severely Frail; 9) Terminally Ill [34]. This scale considers clinical data on the subject's cognition, mobility, functional abilities, and comorbidity, which can be collected through the medical history obtained from the patient, the caregiver, and/or other healthcare providers.
Measured: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
Changes in functional performance of the lower extremities
Short Physical Performance Battery (SPPB) is used to investigate the association between the physical performance and a self-assessed disability by the subjects recruited at a 6-year follow-up. SPPB evaluates the functional capacity of the lower limbs and it consists of three different tests which have been assigned a partial score ranging from 0 to 4.
Measured: evaluation performed at patient's admission and before discharge (approximately 20 days)
Changes in mobility
Timed Up and Go Test (TUG), is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It measures the time it takes a person to get up from a chair, walk ten feet, turn around, come back to the chair and sit down again.
Measured: evaluation performed at patient's admission and before discharge (approximately 20 days)
Changes in functional capacity
6-minute walking test (6MWT) is a self-limited test used to measure functional exercise abilities in people with HF, Acute Coronary Syndrome, and COPD. It is a test in which the person is asked to walk as fast as possible compatible with his clinical condition for a time of 6 minutes, measuring the meters traveled.
Measured: evaluation performed at patient's admission and before discharge (approximately 20 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start21 Apr 2020
- Primary completion9 Jul 2020
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonia Pierobon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonia Pierobon, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230927
- Sponsor's protocol ID
- 2424
- Status last verified
- Feb 2023
- First submitted
- 31 Dec 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Granata N, Vigore M, Maestri R, Callegari G, Guazzotti G, Piaggi G, Cremonese G, Audifreddi S, Pierobon A. Frailty Over Time: A 6-MONTH FOLLOW-UP OF MULTIDISCIPLINARY CARDIAC AND PULMONARY REHABILITATION IN OLDER ADULTS WITH CARDIORESPIRATORY DISEASE. J Cardiopulm Rehabil Prev. 2026 Jun 10. doi: 10.1097/HCR.0000000000001041. Online ahead of print.
PubMed 42268578Vigore M, Granata N, Callegari G, Vaninetti R, Conti S, Maestri R, Piaggi G, Cremonese G, Pierobon A. Frailty and rehabilitation outcome in older patients with cardiorespiratory disease: preliminary multidimensional data. Monaldi Arch Chest Dis. 2022 Dec 1;93(4). doi: 10.4081/monaldi.2022.2447.
PubMed 36458416Vigore M, Granata N, Braga SS, Piaggi G, Audifreddi S, Ferrari M, La Rovere MT, Pierobon A. Cognitive impairment, frailty and rehabilitation outcome in older cardiorespiratory patients. DEC_FRAinRIAB: Study protocol. PLoS One. 2022 Aug 4;17(8):e0272132. doi: 10.1371/journal.pone.0272132. eCollection 2022.
PubMed 35925981
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment, Frailty and Rehabilitative Outcome in Older Patients Affected by Cardiorespiratory Disease (DEC_FRAinRIAB)
- ClinicalTrials.gov ID
- NCT05230927
- Acronym / sponsor ID
- 2424
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Antonia PierobonUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 9 Feb 2022 (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.
A consistent number of studies in the last few years highlighted that the functional and clinical worsening in patients with cardiac and/or respiratory disease/s increase the risk of cognitive decline.
The literature reports a greater diffusion of screening procedures for cognitive deficits in patients with cardiac diseases compared to patients with respiratory diseases. However, in both populations, the interest for cognitive impairment is justified by multiple reasons: the numerous exacerbations of the disease and re-hospitalizations, the difficulty in following complex therapeutic regimens and recognizing worsening of symptoms, the reduced functional autonomy and the rehabilitation outcome . Although recently the Italian Society of Geriatrics and Gerontology has raised the threshold for the definition of the 'elderly' patient from 65 to 75 years to better adapt to the current physical and mental performance of men and women living in economically developed countries and to the demographic situation of the Italian population. Therefore the three classes of 'elderly' patients that we will enroll will be defined as follows: "young old" (65-74 years), "old" (75-84 years), and "old-old" (≥85 years). In general, the age of the eligible sample is defined as ≥ 65 years.
Furthermore, in chronic diseases, emotional factors, such as anxiety and depression, also play an important role in disease adaptation and in the rehabilitation outcome in both cardiac and respiratory diseases.
Alongside the problems relating to emotional aspects and cognitive decline, the frailty syndrome is noteworthy, particularly in the elderly and in the presence of cardiac/respiratory diseases. Frailty is associated with the loss of functionality that leads to greater vulnerability to adverse events such as the increased risk of falls, hospitalization, institutionalization, disability and mortality.
Frailty screening or assessment scales provide predictive information on the risk of death and institutionalization and they are a good predictor of acute hospital outcomes too. Instead, concerning what emerges from international literature, in rehabilitation cardiology, despite the increase in the presence of elderly patients, the clinical and prognostic relevance of frailty has not yet been well defined and measured. On the other hand, recent studies points out that frailty is present in 1/4 of outpatient COPD patients, it is an independent predictor of rehabilitation program interruption and it is also easily reversible in the short term after rehabilitation, thus frailty appears to be one of the relevant aspects in rehabilitative treatment.
In light of the data in the literature, the purposes of this prospective observational study are to evaluate the following objectives:
- At baseline, the presence of cognitive impairment, anxiety, depression, the assessment of self-reported adherence to therapeutic prescriptions and frailty in a sample of elderly patients (age ≥65) with chronic cardiorespiratory disease admitted for a cardiorespiratory rehabilitation cycle and the correlation with disease severity and functional aspects.
- In follow-up, the impact that these factors have on the rehabilitation outcome at the end of hospitalization and on the state of health at six months (telephone interview).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Heart Failure | – | Other: Multidisciplinary Rehabilitation |
| Chronic Obstructive Pulmonary Disease | – | Other: Multidisciplinary Rehabilitation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- CHF was defined as: I) signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral edema) and symptoms of HF [New York Heart Association (NYHA) functional class II-IV] in the presence of reduced ejection fraction (LVEF <40%); or II) signs and symptoms of HF (e.g. elevated brain natriuretic peptides and significant structural heart disease/diastolic dysfunction) with mid-range ejection fraction (LVEF 40-49%) or preserved (LVEF ≥50%). Patients were diagnosed according to Global initiative for chronic Obstructive Lung Disease (GOLD) criteria (Stage II-IV, C-D); they were in clinically stable condition (no exacerbations in the last 3 months) with optimized stable pharmacological therapy (inhalation therapy with long-acting anticholinergic and/or β2-agonists, inhaled corticosteroids when needed).
Key inclusion criteria (1 listed)
- All inpatients admitted to the Cardiac Rehabilitation Department and the Pulmonary Rehabilitation Department of ICS Maugeri - Tradate (Varese) and Montescano (Pavia) affected by CHF or COPD.
Key exclusion criteria (6 listed)
- severe clinical conditions (chronic inflammatory diseases, neoplasia)
- psychiatric and neurological conditions(at anamnestic or actual clinical evaluation),
- no Italian education, illiteracy or relapse into illiteracy,
- severe visuo-perceptive deficits,
- lack of motivation or refusal to undergo the evaluation,
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 |
|---|---|---|
| Multidisciplinary RehabilitationAll patients admitted to an inpatient rehabilitation program will undergo medical history collection, physical, clinical, and functional examination, exercise testing, educational sessions, exercise training (cycle ergometer/treadmill, arm ergometer, breathing, and strength exercises where indicated, calisthenics exercises), psychological counseling, and metabolic evaluation with a personalized diet when needed. | Other | Chronic Heart Failure, Chronic Obstructive Pulmonary Disease |
Primary outcome
Changes in cognitive status
Time frame: evaluation performed at patient's admission and before discharge (approximately 20 days)
Addenbrooke's Cognitive Examination III (ACE III) is a 20 minutes screening test, designed for the early detection of cognitive deterioration. It provides a score from 0 to 100 and it analyzes the following five cognitive domains: Attention-Orientation (ACE III-AO = 0-18), Memory (ACE III-M 0 0-26), Verbal Fluency (ACE III-VF = 0-14), Language (ACE III-L = 0-26), and Visuospatial abilities (ACE III-VS = 0-16). Frontal Assessment Battery (FAB) is a neuropsychological screening test used to assess executive functions. It is a quick and easy test to administer, its score ranges from 0 to 18, and it is divided into the following six sub-tests: conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental dependency.
Changes in Health-related Quality of Life
Time frame: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
The EQ-5D-5L is a generic quality of life measurement tool. It investigates the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has five levels: 1, no problem; 2, slight problem; 3 moderate problem; 4 severe problem; 5 extreme problem. The second section consists of a Visual Analogue Scale (VAS) from 0 (Worst imaginable health state) to 100 (Best imaginable health state), where the subject is asked to indicate the level of self-perceived wellness.
Changes in psychological characteristics
Time frame: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
Patient Health Questionnaire-9 (PHQ-9) is a scale used to determine the diagnosis, severity, and subsequent monitoring of depressive illnesses of the patient. It is divided into nine sub-items, to identify depressive symptoms within the last two weeks (following DSM criteria). The final score has a range between 0-27 and it is divided into clinical variability ranges according to a continuum of symptom severity, where scores of 5, 10, 14, and 19 are considered cut-offs for subthreshold, mild major, moderate major, and severe major depression. Generalized Anxiety Disorder-7 (GAD) is a questionnaire built to measure the severity of anxiety symptoms in the previous two weeks. The questionnaire consists of 7 items and it organizes the severity of the responses on a 4-point Likert scale. The range scores range from 0 to 21, where scores of 5, 10, and 15 are considered cut-offs for mild, moderate, and severe anxiety, respectively.
Changes in self-reported adherence
Time frame: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
The Antecedents and Self-efficacy on Adherence Schedule (ASonA) is a self- report schedule aimed to evaluate cognitive, behavioral, and emotional determinants of pharmacological and non-pharmacological adherence. It is a 21-item schedule scored on a 5-point Likert scale (0=not at all, 4=very much). The schedule comprises 3 subscales: Antecedents (ASonA-A), which include health condition and health-related limitations acceptance, social support and knowledge about health condition; Self- efficacy (ASonA-SE), exploring patients' self-care strategies, and patients' ability to adhere to medication assumption and to non-pharmacological recommendations (i.e., physical activity, diet, alcohol consumption, and smoking avoidance); and Affectivity (ASonA-Aff) which measures patients' emotional aspects in relation to the health condition.
Frailty evaluation
Time frame: evaluation performed at patient's admission
Frailty Index (FI) is a frailty measurement tool created through a geriatric assessment study including non-institutionalized patients. The variables taken into consideration are mobility, muscle strength, comorbidities, cognitive deficits, mood, anthropometric indices, mini nutritional assessment, and social support. It is made up of 40 items and 17 additional items relating to the Social Support Scale.
Changes in frailty status
Time frame: evaluation performed at patient's admission, before discharge (approximately 20 days) and at 6 months telephone follow-up
Clinical Frailty Scale (CFS) is a scale developed in Canada, which is based on clinical judgment only with a score ranging from 1 to 9: 1) Very Fit; 2) Well; 3) Managing Well; 4) Vulnerable; 5) Mildly Frail; 6) Moderately; Frail; 7) Severely frail; 8) Very severely Frail; 9) Terminally Ill [34]. This scale considers clinical data on the subject's cognition, mobility, functional abilities, and comorbidity, which can be collected through the medical history obtained from the patient, the caregiver, and/or other healthcare providers.
Changes in functional performance of the lower extremities
Time frame: evaluation performed at patient's admission and before discharge (approximately 20 days)
Short Physical Performance Battery (SPPB) is used to investigate the association between the physical performance and a self-assessed disability by the subjects recruited at a 6-year follow-up. SPPB evaluates the functional capacity of the lower limbs and it consists of three different tests which have been assigned a partial score ranging from 0 to 4.
Changes in mobility
Time frame: evaluation performed at patient's admission and before discharge (approximately 20 days)
Timed Up and Go Test (TUG), is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It measures the time it takes a person to get up from a chair, walk ten feet, turn around, come back to the chair and sit down again.
Changes in functional capacity
Time frame: evaluation performed at patient's admission and before discharge (approximately 20 days)
6-minute walking test (6MWT) is a self-limited test used to measure functional exercise abilities in people with HF, Acute Coronary Syndrome, and COPD. It is a test in which the person is asked to walk as fast as possible compatible with his clinical condition for a time of 6 minutes, measuring the meters traveled.
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 2 Mar 2023.
- Derived from this study: PubMed 42268578Granata N, Vigore M, Maestri R, Callegari G, Guazzotti G, Piaggi G, Cremonese G, Audifreddi S, Pierobon A. Frailty Over Time: A 6-MONTH FOLLOW-UP OF MULTIDISCIPLINARY CARDIAC AND PULMONARY REHABILITATION IN OLDER ADULTS WITH CARDIORESPIRATORY DISEASE. J Cardiopulm Rehabil Prev. 2026 Jun 10. doi: 10.1097/HCR.0000000000001041. Online ahead of print.
- Derived from this study: PubMed 36458416Vigore M, Granata N, Callegari G, Vaninetti R, Conti S, Maestri R, Piaggi G, Cremonese G, Pierobon A. Frailty and rehabilitation outcome in older patients with cardiorespiratory disease: preliminary multidimensional data. Monaldi Arch Chest Dis. 2022 Dec 1;93(4). doi: 10.4081/monaldi.2022.2447.
- Derived from this study: PubMed 35925981Vigore M, Granata N, Braga SS, Piaggi G, Audifreddi S, Ferrari M, La Rovere MT, Pierobon A. Cognitive impairment, frailty and rehabilitation outcome in older cardiorespiratory patients. DEC_FRAinRIAB: Study protocol. PLoS One. 2022 Aug 4;17(8):e0272132. doi: 10.1371/journal.pone.0272132. eCollection 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Heart Failure and Chronic Obstructive Pulmonary Disease, run by Antonia Pierobon at 1 site in Italy.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 2 Mar 2023. 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 Italy. 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?
Changes in cognitive status (time frame: evaluation performed at patient's admission and before discharge (approximately 20 days)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05230927, which also lists 3 linked publications.
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 2 Mar 2023.