Effects of Different Exercise Training Programs in CKD 4-5

Chronic Kidney Disease Clinical Trial

— RENEXC  

Official title:

Long-term Effects of Basic Aerobic Training Combined With Either Resistance - or Balance Training in CKD Patients - a Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02041156
• Other study ID #: 2011:369
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2014
• Last updated: September 22, 2016
• Start date: October 2011
• Est. completion date: February 2017

Study information

• Verified date: September 2016
• Source: Region Skane
• Contact: Naomi Clyne, MD,PhD
• Phone: +4646 171682
• Email: Naomi.Clyne[@]med.lu.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The investigators' purpose is to study which exercise training modality: aerobic physical activity in conjunction with either resistance training or balance training, is most beneficial in patients with chronic kidney disease (CKD 4-5: GFR < 30 ml/min/1.73mUP[2]). Furthermore, our purpose is to evaluate the long-term effects of exercise training on functional status, cardiovascular morbidity, blood pressure control, heart rate variability, cardiac function, inflammation, body composition, nutritional status, progression of uraemia and health related quality of life. This interventional study is prospective, randomized and controlled comprising 150 prevalent and incident patients from our outpatient clinic. Patients are invited to participate in the study consecutively, irrespective of basic functional status. At start patients are randomised either to resistance or balance training and the programme is adapted and individualised to each patient's actual physical status and ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping the intensity constant at a level of "somewhat strenuous" to "strenuous" on the Borg scale rate of perceived exertion. The total observation period is 12 months with checks every four months. Although exercise training is a recommended therapy in CKD, there is a lack of medical and scientific evidence on optimal prescription. We hope that this study will provide evidence-based knowledge on exercise prescription and its effects on various risk factors in CKD patients. Finally, if patients achieve a higher degree of physical functional capacity they should be able to maintain an autonomous lifestyle, resulting in considerable reductions in societal costs for care and transportation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CKD 4 and 5

• over 18 years of age

• no neurological or orthopedic impairments

• stable cardiac status

Exclusion Criteria:

• not on renal replacement therapy

• no severe electrolyte disturbances

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• aerobic and resistance training

• aerobic combined with balance training

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance to exercise training protocol		4, 8 and 12 month	No
Primary	Physical function	6 minutes walking test, 30 seconds sit to stand, stair climbing, handgrip strength, Isometric quadriceps strength, functional reach, standing heel rise, toes lift, picking-up test, Berg balance scale	4, 8 and 12 months	No
Secondary	Cardiovascular morbidity		after 12 months	No
Secondary	Body composition		after 12 months	No
Secondary	Quality of Life		4,8 and 12 months	No
Secondary	Inflammatory activity		4, 8 and 12 months	No
Secondary	Bone density		12 months	No