Effect of Exercise on Renal Function in Predialysis

NCT ID: NCT02155036

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-06-30

Brief Summary

The proposed research aims to examine whether regular aerobic exercise can preserve renal function, improve aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life. Ultimately, the research aims to prove that exercise is a more cost-effective and a more efficient use or healthcare resources used in the treatment of patients with CKD. Exercise is a relatively cheap treatment option which is readily available and accessible for this patient population. establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients;

1. Preserves renal function.

2. Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise

exercise intervention

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

The intervention will include 2 sessions of gym-based exercise per week, both of which will be supervised for 3 months, supervision will then decrease to once-weekly until 6 months, and then be through phone support for the remaining 6 months. Warm up and cool down of minimum of five minutes on stationary exercise cycle, rate of perceived exertion (RPE) \~11, followed by gentle stretching. Progressive resistance training (PRT) will use eight PRT machines training large muscle groups (e.g. bench press, latissimus pulldown, bicep curl, triceps pull down, leg press, knee extension, hamstring curl, calf raises). Intensity will be 80% of one repetition maximum (1RM), building up to 3 sets of 8 repetitions. 1RM will be re-assessed monthly, and program adjusted accordingly.

Interventions

Exercise

The intervention will include 2 sessions of gym-based exercise per week, both of which will be supervised for 3 months, supervision will then decrease to once-weekly until 6 months, and then be through phone support for the remaining 6 months. Warm up and cool down of minimum of five minutes on stationary exercise cycle, rate of perceived exertion (RPE) \~11, followed by gentle stretching. Progressive resistance training (PRT) will use eight PRT machines training large muscle groups (e.g. bench press, latissimus pulldown, bicep curl, triceps pull down, leg press, knee extension, hamstring curl, calf raises). Intensity will be 80% of one repetition maximum (1RM), building up to 3 sets of 8 repetitions. 1RM will be re-assessed monthly, and program adjusted accordingly.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• - Stages 3-4 chronic kidney disease (CKD) patients (glomerular filtration rate (GFR) 20-60 mL/min)
• Male or female
• Aged >18 years
• Written informed consent

Exclusion Criteria

• Pregnancy

• Requiring support for ambulation less than 20m
• Vasculitis,
• Proliferative diabetic retinopathy,
• Severe osteodystrophy,
• Uncontrolled diabetes,
• Psychiatric illness, including anxiety, mood and untreated eating disorders
• Infection or course of antibiotics within the last month

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

sharlene greenwood, Bsc

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

Locations

King's College Hospital

London, London, United Kingdom

Countries

United Kingdom

Other Identifiers

KCH11-123

Identifier Type: -

Identifier Source: org_study_id