Effect of Exercise on Renal Function in Predialysis

NCT02155036 | Completed Phase 1 DMC

• 1 other identifier: KCH11-123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Kidney Disease

Keywords

exercise; rehabilitation; kidney function; cardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

• kidney function

  estimated glomerular filtration rate (egfr) creatinine

  up to 12 months

Secondary Outcomes (12)

• Cardio-respiratory fitness testing (VO2peak)

  Baseline, 6 and 12 months

• Pulse Wave Velocity (arterial stiffness)

  Baseline, 6 and 12 months

• Body mass index (BMI)

  Baseline, 6 and 12 months

• weight

  Baseline, 6 and 12 months

• Waist circumference

  Baseline, 6 and 12 months

Study Arms (2)

Usual care

NO INTERVENTION

Usual care

Exercise

ACTIVE COMPARATOR

exercise intervention

Other: Exercise

Interventions

Exercise 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.

Exercise

Eligibility Criteria

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

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Interventions

Exercise

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; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• sharlene greenwood, Bsc

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 4, 2014
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

GB (1)