Patients on Dialysis (Hemodialysis, Peritoneal Dialysis)Phase 4EXCITENCT01255969
EXerCise Introduction To Enhance Performance in Dialysis(EXCITE)
A Phase 4 study testing Exercise in people with Patients on Dialysis (Hemodialysis, Peritoneal Dialysis), run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 1 site in Italy.
Trial summary
To evaluate if a model of intervention based on a low-grade physical program prescribed in the dialysis centre and performed at home can modify the functional capacity and quality of life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular events and vascular access failure in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients on Dialysis (Hemodialysis, Peritoneal Dialysis)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Jul 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on dialysis
- Dialysis vintage>6 mo.
- Age>18 aa.
- Signed informed consent
- Stable clinical conditions
Who cannot join
- -any physical or clinical limitations to deambulation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dialysis Units participating to the EXCITE study in Italy
Reggio Calabria
About this study
Official title: EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study
To evaluate if a model of intervention based on a low-grade physical program prescribed in the dialysis centre and performed at home can modify the functional capacity and quality of life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular events and vascular access failure in dialysis patients.
Read the detailed description
Background Dialysis patients show an exceedingly higher risk of death and cardiovascular complications (1). These patients are also characterized by poor physical performance and reduced quality of life. Observational findings in the United States Renal Data System (USRDS) indicated that physical rehabilitation programs after coronary artery bypass are associated with better clinical outcomes in this population (2). However, the hypothesis that physical training in dialysis patients may translate into better physical performance and clinical outcomes has never been tested in large randomized clinical trials. In studies performed so far, physical exercise was proposed during the dialysis session or between two dialysis sessions. These programs imply compliance, organization and cost problems, mainly related with intensification of visit to the dialysis centre. To limit these difficulties, a single easy-to-implement program of physical exercise for dialysis patients, prescribed in the dialysis centre but performed at home, has been recently elaborated and a pilot study has shown that this program improves physical performance in medium term (3).
Purpose This clinical trial tests whether a physical program prescribed in the dialysis centre but performed at home improves the degree of fitness and the quality of life in dialysis patients.
Study population
- Inclusion Criteria:
- 500 Patients on dialysis
- Dialysis vintage>6 months
- Age>18 years
- Signed informed consent
- Stable clinical conditions
- Exclusion Criteria:
- physical or clinical limitations to deambulation
Outcomes:
- Functional capacity : Evaluation of the variation in the distance covered in a pre-determined time with a validated walking test (six minute walking test); Evaluation of the variation in the time needed to complete 5 cycles of the "sit-to-stand-to sit" test.
- Quality of Life : Score obtained by a validated questionnaire for dialysis patients (Kidney Disease Quality of Life instrument o KDQOL).
- Fatal and non-fatal events (cardiovascular and all-causes).
- All-cause hospitalizations.
- Vascular access survival. The power analysis was performed by calculating the sample size for each clinical outcome contemplated by the study protocol. The overall sample size of the trial is that portended by the calculation demanding the highest individuals numbers (that of the outcome "fatal and non fatal cardiovascular events" in our instance).
In a previous observational study by our group, the incident rate of fatal and non fatal cardiovascular events was at three years 25% (4). We hypothesised that the physical exercise will produce a 10% reduction in the hazard ratio of fatal cardiovascular events (hazard ratio: 0.70) as compared to that of the control group.
References:
- Mallamaci F, Tripepi G, Cutrupi S, Malatino LS, Zoccali C. Prognostic value of combined use of biomarkers of inflammation, endothelial dysfunction, and myocardiopathy in patients with ESRD. Kidney Int. 2005 Jun;67(6):2330-7. PMID: 15882276
- Kutner NG, Zhang R, Huang Y, Herzog CA. Cardiac rehabilitation and survival of dialysis patients after coronary bypass. J Am Soc Nephrol. 2006 Apr;17(4):1175-80. Epub 2006 Feb 15. PMID: 16481413
- Malagoni AM, Catizone L, Mandini S, Soffritti S, Manfredini R, Boari B, Russo G, Basaglia N, Zamboni P, Manfredini F. Acute and long-term effects of an exercise program for dialysis patients prescribed in hospital and performed at home. J Nephrol. 2008 Nov-Dec;21(6):871-8. PMID: 19034871
- Zoccali C, Tripepi G, Mallamaci F.Predictors of cardiovascular death in ESRD.Semin Nephrol. 2005 Nov;25(6):358-62
- Being tested
- Exercise
- Keywords
- Dialysis, Physical exercise, Clinical Trial, Quality of Life, Performance, Fitness, Cardiovascular Mortality, Vascular access
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Personalized exercise program
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Exercise | Experimental | Patients in this arm will undergo to personalized exercise program. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Measured: 6 months
Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Measured: 6 months
Secondary outcomes (2)
Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival.
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Measured: 6 months
All - causes and cardiovascular hospitalizations
Hospitalizations will be characterized by ICD-9 codes. Six months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Patients on Dialysis (Hemodialysis, Peritoneal Dialysis)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Carmine Zoccali, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Investigators
- Carmine Zoccali, Prof., Study director, CNR-IBIM and Nephrology Unit, Reggio Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255969
- Sponsor's protocol ID
- EXCITE-001
- Acronym
- EXCITE
- Status last verified
- Aug 2016
- First submitted
- 7 Dec 2010
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mallamaci F, Tripepi G, Cutrupi S, Malatino LS, Zoccali C. Prognostic value of combined use of biomarkers of inflammation, endothelial dysfunction, and myocardiopathy in patients with ESRD. Kidney Int. 2005 Jun;67(6):2330-7. doi: 10.1111/j.1523-1755.2005.00338.x.
PubMed 15882276Kutner NG, Zhang R, Huang Y, Herzog CA. Cardiac rehabilitation and survival of dialysis patients after coronary bypass. J Am Soc Nephrol. 2006 Apr;17(4):1175-80. doi: 10.1681/ASN.2005101027. Epub 2006 Feb 15.
PubMed 16481413Malagoni AM, Catizone L, Mandini S, Soffritti S, Manfredini R, Boari B, Russo G, Basaglia N, Zamboni P, Manfredini F. Acute and long-term effects of an exercise program for dialysis patients prescribed in hospital and performed at home. J Nephrol. 2008 Nov-Dec;21(6):871-8.
PubMed 19034871Mallamaci F, Bratsiakou A, D'Arrigo G, Tripepi G, Lamberti N, Torino C, Manfredini F, Zoccali C. Sex Differences in the EXerCise Introduction to Enhance Performance in Dialysis Trial. Clin J Am Soc Nephrol. 2025 Jun 13;20(8):1072-1078. doi: 10.2215/CJN.0000000759.
PubMed 40512565Mallamaci F, D'Arrigo G, Tripepi G, Lamberti N, Torino C, Manfredini F, Zoccali C. Long-Term Effect of Physical Exercise on the Risk for Hospitalization and Death in Dialysis Patients: A Post-Trial Long-Term Observational Study. Clin J Am Soc Nephrol. 2022 Aug;17(8):1176-1182. doi: 10.2215/CJN.03160322. Epub 2022 Jul 25.
PubMed 35878932Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
PubMed 35018639Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.
PubMed 30342464Manfredini F, Lamberti N, Malagoni AM, Felisatti M, Zuccala A, Torino C, Tripepi G, Catizone L, Mallamaci F, Zoccali C. The role of deconditioning in the end-stage renal disease myopathy: physical exercise improves altered resting muscle oxygen consumption. Am J Nephrol. 2015;41(4-5):329-36. doi: 10.1159/000431339. Epub 2015 Jun 11.
PubMed 26067552Torino C, Manfredini F, Bolignano D, Aucella F, Baggetta R, Barilla A, Battaglia Y, Bertoli S, Bonanno G, Castellino P, Ciurlino D, Cupisti A, D'Arrigo G, De Paola L, Fabrizi F, Fatuzzo P, Fuiano G, Lombardi L, Lucisano G, Messa P, Rapana R, Rapisarda F, Rastelli S, Rocca-Rey L, Summaria C, Zuccala A, Tripepi G, Catizone L, Zoccali C, Mallamaci F; EXCITE Working Group. Physical performance and clinical outcomes in dialysis patients: a secondary analysis of the EXCITE trial. Kidney Blood Press Res. 2014;39(2-3):205-11. doi: 10.1159/000355798. Epub 2014 Jul 29.
PubMed 25118076
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study
- ClinicalTrials.gov ID
- NCT01255969
- Acronym / sponsor ID
- EXCITE / EXCITE-001
- Keywords
- Dialysis, Physical exercise, Clinical Trial, Quality of Life, Performance, Fitness, Cardiovascular Mortality, Vascular access
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, ItalyOther government
- Study start
- Apr 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Dec 2010 (estimated)
- 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.
To evaluate if a model of intervention based on a low-grade physical program prescribed in the dialysis centre and performed at home can modify the functional capacity and quality of life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular events and vascular access failure in dialysis patients.
Detailed description
Background Dialysis patients show an exceedingly higher risk of death and cardiovascular complications (1). These patients are also characterized by poor physical performance and reduced quality of life. Observational findings in the United States Renal Data System (USRDS) indicated that physical rehabilitation programs after coronary artery bypass are associated with better clinical outcomes in this population (2). However, the hypothesis that physical training in dialysis patients may translate into better physical performance and clinical outcomes has never been tested in large randomized clinical trials. In studies performed so far, physical exercise was proposed during the dialysis session or between two dialysis sessions. These programs imply compliance, organization and cost problems, mainly related with intensification of visit to the dialysis centre. To limit these difficulties, a single easy-to-implement program of physical exercise for dialysis patients, prescribed in the dialysis centre but performed at home, has been recently elaborated and a pilot study has shown that this program improves physical performance in medium term (3).
Purpose This clinical trial tests whether a physical program prescribed in the dialysis centre but performed at home improves the degree of fitness and the quality of life in dialysis patients.
Study population
- Inclusion Criteria:
- 500 Patients on dialysis
- Dialysis vintage>6 months
- Age>18 years
- Signed informed consent
- Stable clinical conditions
- Exclusion Criteria:
- physical or clinical limitations to deambulation
Outcomes:
- Functional capacity : Evaluation of the variation in the distance covered in a pre-determined time with a validated walking test (six minute walking test); Evaluation of the variation in the time needed to complete 5 cycles of the "sit-to-stand-to sit" test.
- Quality of Life : Score obtained by a validated questionnaire for dialysis patients (Kidney Disease Quality of Life instrument o KDQOL).
- Fatal and non-fatal events (cardiovascular and all-causes).
- All-cause hospitalizations.
- Vascular access survival. The power analysis was performed by calculating the sample size for each clinical outcome contemplated by the study protocol. The overall sample size of the trial is that portended by the calculation demanding the highest individuals numbers (that of the outcome "fatal and non fatal cardiovascular events" in our instance).
In a previous observational study by our group, the incident rate of fatal and non fatal cardiovascular events was at three years 25% (4). We hypothesised that the physical exercise will produce a 10% reduction in the hazard ratio of fatal cardiovascular events (hazard ratio: 0.70) as compared to that of the control group.
References:
- Mallamaci F, Tripepi G, Cutrupi S, Malatino LS, Zoccali C. Prognostic value of combined use of biomarkers of inflammation, endothelial dysfunction, and myocardiopathy in patients with ESRD. Kidney Int. 2005 Jun;67(6):2330-7. PMID: 15882276
- Kutner NG, Zhang R, Huang Y, Herzog CA. Cardiac rehabilitation and survival of dialysis patients after coronary bypass. J Am Soc Nephrol. 2006 Apr;17(4):1175-80. Epub 2006 Feb 15. PMID: 16481413
- Malagoni AM, Catizone L, Mandini S, Soffritti S, Manfredini R, Boari B, Russo G, Basaglia N, Zamboni P, Manfredini F. Acute and long-term effects of an exercise program for dialysis patients prescribed in hospital and performed at home. J Nephrol. 2008 Nov-Dec;21(6):871-8. PMID: 19034871
- Zoccali C, Tripepi G, Mallamaci F.Predictors of cardiovascular death in ESRD.Semin Nephrol. 2005 Nov;25(6):358-62
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Exercise | Experimental | Other: ExercisePatients in this arm will undergo to personalized exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients on dialysis
- Dialysis vintage>6 mo.
- Age>18 aa.
- Signed informed consent
- Stable clinical conditions
Key exclusion criteria (1 listed)
- -any physical or clinical limitations to deambulation
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 |
|---|---|---|
| ExercisePersonalized exercise program | Other | Exercise |
Primary outcome
Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary
Time frame: 6 months
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test
Time frame: 6 months
6 months is the time frame for the primary analysis but the follow-up will continue until 3 years.
2 secondary outcomes
Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival.
Time frame: 6 months
All - causes and cardiovascular hospitalizations
Time frame: 6 months
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 4 Aug 2016.
- Background: PubMed 15882276Mallamaci F, Tripepi G, Cutrupi S, Malatino LS, Zoccali C. Prognostic value of combined use of biomarkers of inflammation, endothelial dysfunction, and myocardiopathy in patients with ESRD. Kidney Int. 2005 Jun;67(6):2330-7. doi: 10.1111/j.1523-1755.2005.00338.x.
- Background: PubMed 16481413Kutner NG, Zhang R, Huang Y, Herzog CA. Cardiac rehabilitation and survival of dialysis patients after coronary bypass. J Am Soc Nephrol. 2006 Apr;17(4):1175-80. doi: 10.1681/ASN.2005101027. Epub 2006 Feb 15.
- Background: PubMed 19034871Malagoni AM, Catizone L, Mandini S, Soffritti S, Manfredini R, Boari B, Russo G, Basaglia N, Zamboni P, Manfredini F. Acute and long-term effects of an exercise program for dialysis patients prescribed in hospital and performed at home. J Nephrol. 2008 Nov-Dec;21(6):871-8.
- Derived from this study: PubMed 40512565Mallamaci F, Bratsiakou A, D'Arrigo G, Tripepi G, Lamberti N, Torino C, Manfredini F, Zoccali C. Sex Differences in the EXerCise Introduction to Enhance Performance in Dialysis Trial. Clin J Am Soc Nephrol. 2025 Jun 13;20(8):1072-1078. doi: 10.2215/CJN.0000000759.
- Derived from this study: PubMed 35878932Mallamaci F, D'Arrigo G, Tripepi G, Lamberti N, Torino C, Manfredini F, Zoccali C. Long-Term Effect of Physical Exercise on the Risk for Hospitalization and Death in Dialysis Patients: A Post-Trial Long-Term Observational Study. Clin J Am Soc Nephrol. 2022 Aug;17(8):1176-1182. doi: 10.2215/CJN.03160322. Epub 2022 Jul 25.
- Derived from this study: PubMed 35018639Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Derived from this study: PubMed 30342464Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.
- Derived from this study: PubMed 26067552Manfredini F, Lamberti N, Malagoni AM, Felisatti M, Zuccala A, Torino C, Tripepi G, Catizone L, Mallamaci F, Zoccali C. The role of deconditioning in the end-stage renal disease myopathy: physical exercise improves altered resting muscle oxygen consumption. Am J Nephrol. 2015;41(4-5):329-36. doi: 10.1159/000431339. Epub 2015 Jun 11.
- Derived from this study: PubMed 25118076Torino C, Manfredini F, Bolignano D, Aucella F, Baggetta R, Barilla A, Battaglia Y, Bertoli S, Bonanno G, Castellino P, Ciurlino D, Cupisti A, D'Arrigo G, De Paola L, Fabrizi F, Fatuzzo P, Fuiano G, Lombardi L, Lucisano G, Messa P, Rapana R, Rapisarda F, Rastelli S, Rocca-Rey L, Summaria C, Zuccala A, Tripepi G, Catizone L, Zoccali C, Mallamaci F; EXCITE Working Group. Physical performance and clinical outcomes in dialysis patients: a secondary analysis of the EXCITE trial. Kidney Blood Press Res. 2014;39(2-3):205-11. doi: 10.1159/000355798. Epub 2014 Jul 29.
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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.
Carmine Zoccali, Prof. study director
CNR-IBIM and Nephrology Unit, Reggio Calabria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exercise in people with Patients on Dialysis (Hemodialysis, Peritoneal Dialysis), run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy 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 5 inclusion and 1 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 4 Aug 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary (time frame: 6 months). The study lists 2 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 NCT01255969, which also lists 9 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 4 Aug 2016.