SEDentary Lifestyle, Mortality and Major Adverse Clinical Outcomes in Chronic KIDney Disease

NCT06935786 | Recruiting

• 1 other identifier: T1451/2023
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Chronic Kidney Disease; Cardiovascular Diseases; Frailty

Keywords

Chronic Kidney Disease; Cardiovascular Diseases; Renal Replacement Therapy; Frailty; Mortality; Hospitalisations; Exercise Program; Quality of Life; Emergency Department Visit; Major Adverse Cardiovascular and Cerebrovascular Events

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (3)

• Maximal oxygen uptake in the exercise stress test

  1 year, 2 years, 3 years, 5 years, 31 Dec 2031

• Change in Quality of life

  1 year, 2 years, 3 years, 5 years, 31 Dec 2031

• Bone fractures

  1 year, 2 years, 3 years, 5 years, 31 Dec 2031

Study Arms (2)

Exercise Program

EXPERIMENTAL

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Standard of Care

NO INTERVENTION

Interventions

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.

Also known as: physical training education program

Exercise Program

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>40 years
• Estimated glomerular filtration rate \< 20ml/min/1.73m2 (CKD stage 4-5)
• Informed consent from the patient is received

You may not qualify if:

• Pregnant women
• Patient's lack of commitment to follow-up
• Chronic or acute clinical condition with a prognosis less than 6 months
• Amputated lower limbs

Sponsors & Collaborators

• Turku University Hospital: lead
• Satasairaala: collaborator
• Vaasa Central Hospital, Vaasa, Finland: collaborator

Study Sites (3)

Satasairaala Hospital

Pori, 28500, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, 20520, Finland

RECRUITING

Vaasa Central Hospital

Vaasa, 65130, Finland

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases; Frailty

Interventions

Exercise; Dosage Forms

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• 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

Central Study Contacts

Markus Hakamäki, MD, PhD

CONTACT

+35823130000; markus.hakamaki@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: April 20, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

FI (3)