Effects of Different Exercise Training Programs in CKD 4-5

Not Applicable

• Conditions: Chronic Kidney Disease
• Interventions: Other: aerobic and resistance training; Other: aerobic combined with balance training

• Registration Number: NCT02041156
• Lead Sponsor: Region Skane

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aerobic with resistance training	aerobic and resistance training	Regular aerobic activity combined with 3 sessions/week of resistance training totalling 150 minutes per week of physical activity
aerobic with balance training	aerobic combined with balance training	Regular aerobic activity combined with 3 sessions/week of balance training totalling 150 minutes per week of physical activity

Primary Outcome Measures

Name	Time	Method
Physical function	4, 8 and 12 months	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

Secondary Outcome Measures

Name	Time	Method
Body composition	after 12 months
Bone density	12 months
Cardiovascular morbidity	after 12 months
Inflammatory activity	4, 8 and 12 months
Quality of Life	4,8 and 12 months

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Lund, Sweden