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| Name | Class |
|---|---|
| Satasairaala | OTHER |
| Vaasa Central Hospital, Vaasa, Finland | OTHER |
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The goal of this study is to learn if a simple home exercise program can benefit patients with advanced chronic kidney disease. There is also an observational part of the study without an exercise program.
The study will record patients' mortality, cardiovascular events, emergency department visits, hospital stays, need for dialysis and 6 minutes walking distance. Also maximal oxygen uptake, quality of life and bone fractures are recorded and blood tests and X-rays analyzed. The prospective observational part of the study will investigate the link between cardiovascular and kidney health as well as exercise capacity and adverse outcomes.
The prevalence of chronic kidney disease (CKD) and patients on maintenance dialysis is increasing, and affected patients are at elevated risk of premature death and adverse cardiovascular events.
Frailty is a term used to describe aging related attenuation of physical, mental, psychological and cognitive performance. Frailty is common in patients with CKD. Frailty is associated with increased mortality, hospitalization and falls in both the general population and in CKD.
Treatment of frailty is challenging due to its multidimensional nature and the old age and comorbidity of the affected patients. In spite these challenges, physical rehabilitation and training programs have been shown to successfully improve the prognosis of patients with CKD.
The investigators hypothesize that marked frailty is associated with a weak prognosis in spite renal replacement therapy and kidney transplantation. Because advanced predialysis stage CKD carries a high risk of adverse events and kidney transplants available are scarce, it is imperative to identify those elderly CKD stage 5 patients that benefit from initiating renal replacement therapy and those who are unlikely to benefit to avoid futile intensive treatment when it does not improve prognosis or quality of life. The investigators expect that the progression of frailty may up to a point be hindered using a simple physical exercise program that can be produced cost effectively to aid a large number of patients.
The trial aims to examine the benefits of an individual physical training education program in advanced CKD. In addition to the controlled trial setting the study examines the association between measures of frailty, physical and psychological capability assessed at study inclusion (baseline) and incident hospitalization, mortality, renal replacement therapy (RRT) and major adverse cardiovascular events during follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Program | Experimental |
| |
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | Behavioral | Single appointment with a registered physiotherapist educating the patient for rehabilitating physical training and exercise to be performed independently and regularly by the patient at home, minimum of three times a week, during the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalisations | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 | |
| Mortality | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 | |
| Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 | |
| Emergency Department Visits | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 | |
| 6-minute Walking Test Distance | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 | |
| Renal Replacement Therapy | start of dialysis or kidney transplantation | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 |
| Compliance to the home training program | Compliance of the intervention group assessed at every clinical control visit and tri-monthly by telephone. | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal oxygen uptake in the exercise stress test | Measured by spiroergometry (adjusted by body weight ml/kg/min) | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 |
| Change in Quality of life | Measured by RAND-36 questionnaire (8 domains and 2 composite scores, scale 0-100, higher score indicating better quality of life) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markus Hakamäki, MD, PhD | Contact | +35823130000 | markus.hakamaki@tyks.fi |
| Name | Affiliation | Role |
|---|---|---|
| Tapio Hellman, MD, PhD | Turku University Hospital and University of Turku | Principal Investigator |
| Mikko J Järvisalo, MD, PhD | Satasairaala Hospital, Wellbeing Services County of Satakunta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satasairaala Hospital | Not yet recruiting | Pori | 28500 | Finland | ||
| Turku University Hospital |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
|
| 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 |
| Bone fractures | Number of participants with incident fractures, total number of fractures | 1 year, 2 years, 3 years, 5 years, 31 Dec 2031 |
| Recruiting |
| Turku |
| 20520 |
| Finland |
| Vaasa Central Hospital | Recruiting | Vaasa | 65130 | Finland |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |