Chronic Kidney Disease Stage 3 and 4EXACT-CKDPADNCT06621264
Exercise Activity to Improve Mobility in Patients With CKD and PAD
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Chronic Kidney Disease Stage 3 and 4 and Peripheral Artery Disease (PAD), run by University Hospital of Ferrara at 3 sites in Italy.
Trial summary
People affected by chronic kidney disease and concomitant diagnosed peripheral artery disease at intermediate stages, without contraindications to exercise therapy will be invited to participate in the study. Whose providing informed consent, will be randomly assigned to one of two groups: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease Stage 3 and 4, Peripheral Artery Disease (PAD)
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic kidney disease at KDOQI stages III or IV and concomitant Peripheral artery disease at stages I, II, III;
- ability to walk independently;
- cognitive function to give informed consent identified by a Mini Mental Status Examination score greater or equal to 20/30
- absence of clinical conditions contraindicating exercise therapy (e.g., unstable angina, severe heart failure at NYHA class IV, anemia with lower than 10.0 g/dl).
Who cannot join
- major amputations;
- major surgery planned in the next 3 months;
- known comorbid conditions that may limit survival to less than 2 years;
- inability or unwillingness to comply with protocol requirements.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
University Hospital of Ferrara
Ferrara, Italy, 44124
Fabio Manfredini Prof. Fabio Manfredini, MD PhD, 00390532236187, fabio.manfredini@unife.it
Fabio Manfredini, MD PhD
- Recruiting
Ospedale Pederzoli Peschiera del Garda
Peschiera del Garda, Italy
Yuri Battaglia Prof. Yuri Battaglia, MD PhD, 0039+0456449111, yuri.battaglia@univr.it
Yuri Battaglia, MD PhD
- Recruiting
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
Vincenzo Panuccio Dr. Vincenzo Panuccio, MD, 0039+0965397111, enzopanuccio@gmail.com
Vincenzo Panuccio, MD
About this study
Official title: EXercise ACTivity to Improve Mobility, Active Behavior and Quality of Life of Chronic Kidney Disease Patients With Peripheral Artery Disease: the EXACTckd-pad Multicenter Randomized Controlled Trial
People affected by chronic kidney disease and concomitant diagnosed peripheral artery disease at intermediate stages, without contraindications to exercise therapy will be invited to participate in the study.
Whose providing informed consent, will be randomly assigned to one of two groups:
Read more
- Exercise program receiving two daily 10-minute interval walking sessions at a slow increasing speed.
- Control group: receiving usual care including optimal medical therapy and nutritional advice.
Patients of both groups will be measured at baseline, after the end of the exercise program (6-month) and at follow up (12-month). Outcome measures will include walking ability by the 6-minute walking test (primary outcome) and lower limbs perfusion, body composition, quality of life, laboratory outcomes and long-term hospitalizations.
Read the detailed description
People with chronic kidney disease (CKD) are exposed to a high risk of developing peripheral artery disease (PAD) and its related adverse health outcomes. This dangerous combination of pathological conditions increases overall cardiovascular risk, mortality and lower limbs amputations.
The scientific literature suggests a strategic co-management of CKD-PAD patients by multidisciplinary teams including specialists of different areas and expertise. Indeed, a common issue is that both these diseases are negatively associated with a sedentary behavior. Exercise therapy may enhance the physical functioning, the risk factors management, the lower limbs vascularization and reduce the cardiovascular risk that affects this population. Since the CKD-PAD population is less likely to be provided recommended optimal care, and considering that 2 out of 3 CKD patients have a completely sedentary behavior for several barriers to training participation, proper exercise programs should be developed. This multicenter randomized-controlled trial aims to test the effectiveness of a 6-month home-based structured walking program on physical functioning and laboratory and clinical outcomes. Purposely 100 CKD patients at KDOQI stages III or IV with concomitant PAD at Rutherford's stages I to III, aged > 18 years and without absolute contraindications to exercise training will be randomized to receive an exercise intervention (Ex) or usual care (Control, Co). The 6-month training intervention, previously tested in PAD and CKD patients, consist in two 10-minute daily interval walking sessions performed inside the home.
Patients will receive a detailed exercise prescription according to their baseline walking capacity, with the walking speed maintained at home through sound pacing by a digital metronome. The prescribed speed will be weekly increased from the 60 to the 100% of their baseline walking speed with a fixed working time throughout the program. Two serial visits during the program will be scheduled to reinforce adherence to exercise, maintained and verified by a digital application, and to control the blood pressure. Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices.
The primary outcome of the study will be the variations of mobility as assessed by the 6-minute walking test at the end of the program. Secondary outcomes will include lower limbs perfusion and strength, body composition and bone mineral density, quality of life, laboratory outcomes including rate of progression of CKD and the long-term hospitalizations and mortality.
Outcome measures will be assessed by blinded operators at baseline, at the end of the program for exercise group (6-month) and at 12 months follow up.
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION, Control (Standard treatment)
- Keywords
- Exercise therapy;, Mobility, Ageing, Chronic Kidney Disease, Peripheral artery disease
- Medical subject headings
- Renal Insufficiency, Chronic, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONBehavioural
Also called exercise, rehabilitation
Patients enrolled in this group will receive a detailed 6-month exercise prescription aimed at providing in-home low fatiguing walking training (at light-moderate intensity, or 2-3 out of 10 of the CR10 Borg\'s scale). The program consists of a two daily 10-minute interval walking sessions (1 minute walking : 1 minute resting) at a prescribed speed controlled by a digital metronome (https://www.youtube.com/watch?v=ki8YX_t-0jA). The training speed will be set up according to the patients baseline walking capacity (approximately 50% lower than the habitual gait speed) and will be weekly increased until reaching the habitual gait speed. The training time will be maintained constant throughout the entire program. Exercise prescription will be updated during two intermediate hospital visits at the 1st and 3rd months. Patients will be provided with a digital application properly developed to keep pacing and to record the correct training execution.
Control (Standard treatment)Other
Also called Usual care
Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Patients enrolled in this group will receive a detailed 6-month exercise prescription aimed at providing in-home low fatiguingwalking training (at light-moderate intensity, or 2-3 out of 10 of the CR10 Borg's scale). The program consists of a two daily 10-minute interval walking sessions (1 minute walking : 1 minute resting) at a prescribed speed controlled by a digital metronome (https://www.youtube.com/watch?v=ki8YX_t-0jA). The training speed will be set up according to the patients baseline walking capacity (approximately 50% lower than the habitual gait speed) and will be weekly increased until reaching the habitual gait speed. The training time will be maintained constant throughout the entire program.
Exercise prescription will be updated during two intermediate hospital visits at the 1st and 3rd months. Patients will be provided with a digital application properly developed to keep pacing and to record the correct training execution. Receives: Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
| Control group | Placebo comparator | Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking test
The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters
Measured: Baseline; End of program (6-month); Follow up (12-month)
Secondary outcomes (11)
Lower limbs perfusion
This measure will be performed according to the published standards with the patient laying by dividing the blood pressure at the ankle with the systolic blood pressure.
Measured: Baseline; end of the program (6-month); Follow up (12-month).
handgrip strength will be measured by a standard dynamometer
both hands, patients will be asked to perform three repetitions. The peak and mean values are collected
Measured: Baseline; end of the program (6-month); Follow up (12-month).
Quality of life will be assessed by the short-form 36 (SF-36) questionnaire
This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks
Measured: Baseline; end of the program (6-month); Follow up (12-month).
Bone mineral density
bone mineral density will be measured through phalangeal quantitative ultrasound with an ultrasound signal of 1.25 MHz frequency and a methodology devoid of X-rays. The results are consistent with those obtained by standard DEXA
Measured: Baseline; end of the program (6-month); Follow up (12-month).
lower limbs strength assessed by the 5-time sit-to-stand test
Patients will raise up from a standard height chair with their arms folded across the chest five times as quickly as possible. The total time elapsed for completing the five repetitions is recorded in seconds
Measured: Baseline; end of the program (6-month); Follow up (12-month).
Body mass index
Body composition will be assessed with direct measures of height and weight. Body mass index will be calculated as the ratio between weight (in kg) and the squared height (in meters)
Measured: Baseline, end of the program (6-month); follow up (12-month)
Circulating indexes of kidney function
Serum creatinine will be directly measured through standard laboratory methods. The estimated glomerular filtration rate will be calculated through the 2009 Chronic Kidney Disease Epidemiology Collaboration equation
Measured: Baseline, end of treatment (6-month); follow up (12-month)
Long-term survival rate
All-cause mortality of the enrolled patients will be checked from the regionals datasets. In case of positive findings, the days elapsed from enrollment to the event will be recorded for additional analyses, as well as the reasons and the diagnoses.
Measured: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
Long-term hospitalizations
All-cause hospitalization will be checked from the regionals datasets. In case of positive findings, the days elapsed from enrollment to the event will be recorded for additional analyses, as well as the reasons and the diagnoses.
Measured: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
Rate of admission to dialysis
Number of patients that will be admitted to dialysis will be recorded and the time from enrollment to the dialysis admission will calculated
Measured: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
Pain-free walking distance
During the 6-minute walking test, the distance at the onset of symptoms referred by the patient will be collected and reported
Measured: Baseline, end of treatment (6-month), follow up (12-month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024
- Primary completion20 Nov 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 3 and 4Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona, Reggio Calabria
- Responsible party
- Principal investigator, Fabio Manfredini, University Hospital of Ferrara
- Investigators
- Roberto Manfredini Prof. Roberto Manfredini, MD, PhD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621264
- Sponsor's protocol ID
- PNRR-MAD-2022-12376611
- Acronym
- EXACT-CKDPAD
- Status last verified
- May 2025
- First submitted
- 26 Sep 2024
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The database generated for the study with anonimyzed patients\' characteristics will be available on institution public repository
Publications
Manfredini F, Panuccio V, Battaglia Y, Storari A, Lamberti N, Piva G, Veronesi M, Tripepi R, Rinaldo N, Crepaldi A, Momente C, Piccinini A, Traina L, Fargion AT, Straudi S, Baroni A, De Giorgi A, Martinuzzi C, Monesi M, Capitanini A, Aucella F, Cupisti A, Mallamaci F, Zoccali C, Manfredini R. Exercise therapy to improve mobility, active behaviour and quality of life of chronic kidney disease patients with peripheral artery disease: study protocol for the EXACT-CKDPAD multicentre randomised controlled trial. BMJ Open Sport Exerc Med. 2025 Jul 15;11(3):e002740. doi: 10.1136/bmjsem-2025-002740. eCollection 2025.
PubMed 40672525
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXercise ACTivity to Improve Mobility, Active Behavior and Quality of Life of Chronic Kidney Disease Patients With Peripheral Artery Disease: the EXACTckd-pad Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06621264
- Acronym / sponsor ID
- EXACT-CKDPAD / PNRR-MAD-2022-12376611
- Keywords
- Exercise therapy;, Mobility, Ageing, Chronic Kidney Disease, Peripheral artery disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Universita di Verona, Reggio Calabria
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
People affected by chronic kidney disease and concomitant diagnosed peripheral artery disease at intermediate stages, without contraindications to exercise therapy will be invited to participate in the study.
Whose providing informed consent, will be randomly assigned to one of two groups:
- Exercise program receiving two daily 10-minute interval walking sessions at a slow increasing speed.
- Control group: receiving usual care including optimal medical therapy and nutritional advice.
Patients of both groups will be measured at baseline, after the end of the exercise program (6-month) and at follow up (12-month). Outcome measures will include walking ability by the 6-minute walking test (primary outcome) and lower limbs perfusion, body composition, quality of life, laboratory outcomes and long-term hospitalizations.
Detailed description
People with chronic kidney disease (CKD) are exposed to a high risk of developing peripheral artery disease (PAD) and its related adverse health outcomes. This dangerous combination of pathological conditions increases overall cardiovascular risk, mortality and lower limbs amputations.
The scientific literature suggests a strategic co-management of CKD-PAD patients by multidisciplinary teams including specialists of different areas and expertise. Indeed, a common issue is that both these diseases are negatively associated with a sedentary behavior. Exercise therapy may enhance the physical functioning, the risk factors management, the lower limbs vascularization and reduce the cardiovascular risk that affects this population. Since the CKD-PAD population is less likely to be provided recommended optimal care, and considering that 2 out of 3 CKD patients have a completely sedentary behavior for several barriers to training participation, proper exercise programs should be developed. This multicenter randomized-controlled trial aims to test the effectiveness of a 6-month home-based structured walking program on physical functioning and laboratory and clinical outcomes. Purposely 100 CKD patients at KDOQI stages III or IV with concomitant PAD at Rutherford's stages I to III, aged > 18 years and without absolute contraindications to exercise training will be randomized to receive an exercise intervention (Ex) or usual care (Control, Co). The 6-month training intervention, previously tested in PAD and CKD patients, consist in two 10-minute daily interval walking sessions performed inside the home.
Patients will receive a detailed exercise prescription according to their baseline walking capacity, with the walking speed maintained at home through sound pacing by a digital metronome. The prescribed speed will be weekly increased from the 60 to the 100% of their baseline walking speed with a fixed working time throughout the program. Two serial visits during the program will be scheduled to reinforce adherence to exercise, maintained and verified by a digital application, and to control the blood pressure. Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices.
The primary outcome of the study will be the variations of mobility as assessed by the 6-minute walking test at the end of the program. Secondary outcomes will include lower limbs perfusion and strength, body composition and bone mineral density, quality of life, laboratory outcomes including rate of progression of CKD and the long-term hospitalizations and mortality.
Outcome measures will be assessed by blinded operators at baseline, at the end of the program for exercise group (6-month) and at 12 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONPatients enrolled in this group will receive a detailed 6-month exercise prescription aimed at providing in-home low fatiguingwalking training (at light-moderate intensity, or 2-3 out of 10 of the CR10 Borg's scale). The program consists of a two daily 10-minute interval walking sessions (1 minute walking : 1 minute resting) at a prescribed speed controlled by a digital metronome (https://www.youtube.com/watch?v=ki8YX_t-0jA). The training speed will be set up according to the patients baseline walking capacity (approximately 50% lower than the habitual gait speed) and will be weekly increased until reaching the habitual gait speed. The training time will be maintained constant throughout the entire program. Exercise prescription will be updated during two intermediate hospital visits at the 1st and 3rd months. Patients will be provided with a digital application properly developed to keep pacing and to record the correct training execution. |
| Control group | Placebo comparator | Other: Control (Standard treatment)Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic kidney disease at KDOQI stages III or IV and concomitant Peripheral artery disease at stages I, II, III;
- ability to walk independently;
- cognitive function to give informed consent identified by a Mini Mental Status Examination score greater or equal to 20/30
- absence of clinical conditions contraindicating exercise therapy (e.g., unstable angina, severe heart failure at NYHA class IV, anemia with lower than 10.0 g/dl).
Key exclusion criteria (4 listed)
- major amputations;
- major surgery planned in the next 3 months;
- known comorbid conditions that may limit survival to less than 2 years;
- inability or unwillingness to comply with protocol requirements.
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 |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAlso: exercise, rehabilitationPatients enrolled in this group will receive a detailed 6-month exercise prescription aimed at providing in-home low fatiguing walking training (at light-moderate intensity, or 2-3 out of 10 of the CR10 Borg\'s scale). The program consists of a two daily 10-minute interval walking sessions (1 minute walking : 1 minute resting) at a prescribed speed controlled by a digital metronome (https://www.youtube.com/watch?v=ki8YX_t-0jA). The training speed will be set up according to the patients baseline walking capacity (approximately 50% lower than the habitual gait speed) and will be weekly increased until reaching the habitual gait speed. The training time will be maintained constant throughout the entire program. Exercise prescription will be updated during two intermediate hospital visits at the 1st and 3rd months. Patients will be provided with a digital application properly developed to keep pacing and to record the correct training execution. | Behavioural | Exercise group |
| Control (Standard treatment)Also: Usual carePatients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices | Other | Control group |
Primary outcome
6-minute walking test
Time frame: Baseline; End of program (6-month); Follow up (12-month)
The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters
11 secondary outcomes
Lower limbs perfusion
Time frame: Baseline; end of the program (6-month); Follow up (12-month).
handgrip strength will be measured by a standard dynamometer
Time frame: Baseline; end of the program (6-month); Follow up (12-month).
Quality of life will be assessed by the short-form 36 (SF-36) questionnaire
Time frame: Baseline; end of the program (6-month); Follow up (12-month).
Bone mineral density
Time frame: Baseline; end of the program (6-month); Follow up (12-month).
lower limbs strength assessed by the 5-time sit-to-stand test
Time frame: Baseline; end of the program (6-month); Follow up (12-month).
Body mass index
Time frame: Baseline, end of the program (6-month); follow up (12-month)
Circulating indexes of kidney function
Time frame: Baseline, end of treatment (6-month); follow up (12-month)
Long-term survival rate
Time frame: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
Long-term hospitalizations
Time frame: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
Rate of admission to dialysis
Time frame: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
Pain-free walking distance
Time frame: Baseline, end of treatment (6-month), follow up (12-month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 40672525Manfredini F, Panuccio V, Battaglia Y, Storari A, Lamberti N, Piva G, Veronesi M, Tripepi R, Rinaldo N, Crepaldi A, Momente C, Piccinini A, Traina L, Fargion AT, Straudi S, Baroni A, De Giorgi A, Martinuzzi C, Monesi M, Capitanini A, Aucella F, Cupisti A, Mallamaci F, Zoccali C, Manfredini R. Exercise therapy to improve mobility, active behaviour and quality of life of chronic kidney disease patients with peripheral artery disease: study protocol for the EXACT-CKDPAD multicentre randomised controlled trial. BMJ Open Sport Exerc Med. 2025 Jul 15;11(3):e002740. doi: 10.1136/bmjsem-2025-002740. eCollection 2025.
- Individual participant dataSharing planned: Yes. The database generated for the study with anonimyzed patients\' characteristics will be available on institution public repository
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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.
Roberto Manfredini Prof. Roberto Manfredini, MD, PhD principal investigator
Università degli Studi di Ferrara
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Chronic Kidney Disease Stage 3 and 4 and Peripheral Artery Disease (PAD), run by University Hospital of Ferrara at 3 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Manfredini Prof. Fabio Manfredini, MD, PhD (+390532236187, fabio.manfredini@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walking test (time frame: Baseline; End of program (6-month); Follow up (12-month)). 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 NCT06621264, which also lists 1 linked publication.
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 31 May 2025.