Clinical trial NCT01255969: EXerCise Introduction To Enhance Performance in Dialysis(EXCITE)
Official title: EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients on Dialysis (Hemodialysis, Peritoneal Dialysis)
Keywords: Dialysis
Physical exercise
Clinical Trial
Quality of Life
Performance
Fitness
Cardiovascular Mortality
Vascular access
Lead sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Sponsor class: OTHER_GOV
First posted: 2010-12-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

1. 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
2. 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
3. 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
4. Zoccali C, Tripepi G, Mallamaci F.Predictors of cardiovascular death in ESRD.Semin Nephrol. 2005 Nov;25(6):358-62

Eligibility criteria: Inclusion Criteria:

* Patients on dialysis
* Dialysis vintage\>6 mo.
* Age\>18 aa.
* Signed informed consent
* Stable clinical conditions

Exclusion Criteria:

-any physical or clinical limitations to deambulation

Primary outcomes:
measure: Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary
timeFrame: 6 months
measure: Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of mortality (all causes and cardiovascular only), non-fatal cardiovascular events, all-causes hospitalizations and dialysis access survival.
timeFrame: 6 months
measure: All - causes and cardiovascular hospitalizations
timeFrame: 6 months
Other outcomes:
Locations:
city: Reggio Calabria
country: Italy
facility: Dialysis Units participating to the EXCITE study in Italy
Study officials:
affiliation: CNR-IBIM and Nephrology Unit, Reggio Calabria
name: Carmine Zoccali, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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. doi: 10.1681/ASN.2005101027. Epub 2006 Feb 15.
citation: 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.
citation: Mallamaci 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.
citation: Bernier-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.
citation: Baggetta 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.
citation: Manfredini 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.
citation: Torino 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.