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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 20 July 2020
Main ID:  ISRCTN69257140
Date of registration: 21/08/2015
Prospective Registration: No
Primary sponsor: University Hospitals of Leicester
Public title: Programmes to encourage exercise and active lifestyles in kidney disease
Scientific title: Programmes to encourage Exercise and Active Lifestyles in kidney disease: a single-centre, interventional study
Date of first enrolment: 01/07/2015
Target sample size: 12
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN69257140
Study type:  Interventional
Study design:  Single-centre interventional study (Quality of life)  
Phase:  Not Applicable
Countries of recruitment
United Kingdom
Contacts
Name: Heather    MacKinnon
Address:  Leicester Kidney Exercise Team University of Leicester Acdemic Unit Leicester General Hospital, LE5 4PW Leicester United Kingdom
Telephone: +44 116 2584346
Email: hjm24@le.ac.uk
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
Participants must:
1. Be >18 years of age
2. Have a diagnosis of Chronic Kidney Disease or have a kidney transplant
3. Be able to provide written consent, read the supported written material and engage in the motivational/educational session
4. Not be considered unfit by their own clinician due to physical impairment, co-morbidity or any other reason for any element of the protocol

Exclusion criteria:
Participants will be excluded if:
1. <18 years of age
2. Are unable to provide written consent, read the supported written material or engage in the motivational/educational session
3. Are considered unfit by their own clinician due to physical impairment, co-morbidity or any other reason for any element of the protocol


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic kidney disease
Urological and Genital Diseases
Chronic kidney disease
Intervention(s)
The intervention will investigate the use of both group and individual sessions to facilitate engagement in a self-directed physical activity (PA) programme. This project aims to test the intervention design; seek feedback, using semi-structured interviews; and update both the design and content based on the qualitative findings. The initial intervention design represents a 6-8 week PA programme, launched using a motivational education session, and supported by written educational material and follow-up phone calls by health care professionals.
Primary Outcome(s)
The primary aim of the trial is to demonstrate patient-acceptability, thus the recruitment, engagement and retention rates are the primary outcome measures.
Secondary Outcome(s)

Secondary outcome measures include a range measure of physical and functional assessments, including:
1. The Incremental and Endurance Shuttle Walk Tests,
2. Short Physical Performance Battery
3. Body composition
4. Cardiac bio-reactance

A range of questionnaires will be used to measure PA levels, quality of life and symptom burden. The appropriateness of the outcome measures will be evaluated as part of the trial and will vary as indicated based on the participant feedback.
Secondary ID(s)
version 1 17th March 2015
Source(s) of Monetary Support
Kidney Research UK
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Research Ethics Committee (NRES Committee East Midlands - Nottingham 2), 22/5/2015, ref: 15/EM/0208
Results
Results available:
Date Posted:
Date Completed: 01/07/2020
URL:
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