Chronic kidney disease Urological and Genital Diseases Chronic kidney disease
Conditions
Interventions
Study design overview
This study is divided into four parts (A, B, C, and D). The researchers aim to recruit a large number of people with kidney disease into Part A (survey) to provid
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A: 1. Patients with established kidney disease according to the National l Institute for Health and Care Excellence (NICE) guidelines (NICE, NICE CKD Guidelines) or identified using the IMPAKT tool [http://www.impakt.org.uk/HOME-459.html] 2. Aged > = 18 years Part B: 1. Patients with established kidney disease according to the National l Institute for Health and Care Excellence (NICE) guidelines (NICE, NICE CKD Guidelines) or identified using the IMPAKT tool [http://www.impakt.org.uk/HOME-459.html] 2. Aged > = 18 years Part C and D: 1. Patients with established kidney disease according to the National l Institute for Health and Care Excellence (NICE) guidelines (NICE, NICE CKD Guidelines) or identified using the IMPAKT tool [http://www.impakt.org.uk/HOME-459.html] 2. Aged > = 18 years
Exclusion criteria
Exclusion criteria: Part A: 1. On a current modality of dialysis 2. Insufficient command of English or any other precluding factors that prevent ability to give informed consent or comply with protocol Part B: 1. On a current modality of dialysis 2. Insufficient command of English or any other precluding factors that prevent ability to give informed consent or comply with protocol Part C and D: 1. On a current modality of dialysis 2. Insufficient command of English or any other precluding factors that prevent ability to give informed consent or comply with protocol 3. Pregnancy 4. Any element of protocol considered by own clinician or General Practitioner (GP) to be contradicted or/and patients unfit to exercise due to any physical impairment, significant co-morbidity or any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PART A Measured at baseline, mid-intervention (8 weeks), and post-intervention (16 weeks): 1. Perceptions of health measured using the 12-item Short Form Health Survey (SF-12) 2. Knowledge, skills and confidence in one’s ability to manage own health measured using the Patient Activation Measure (PAM) 3. Perceived kidney symptoms measured using the Kidney Symptom Questionnaire (KSQ) 4. Perceived strength and mobility measured using the SARC-F questionnaire 5. Muscle problems and its effect on everyday life measured by Sarcopenia and Quality of Life (SarQoL) 6. Subjective physical activity levels measured by the GP Physical Activity Questionnaire (GPPAQ) PART B Experience, understanding and attitudes towards strength and home-based exercise training and perceptions of the participant’s own health and strength, assessed using semi-structured interviews at a single timepoint PART C Participant feedback on the intervention collected via interviews after the end of the 2-week trial home-based exercise intervention PART D Primary feasibility outcome measures: 1. Recruitment rate and time taken to recruit, measured monthly. The number of eligible patients and the number of patients consented are recorded 2. Acceptability of randomisation and assessment procedure determined by comparison of final group characteristics. In addition, loss to follow up is measured and patients’ views from interviews are analysed 3. Adherence assessed by counting the number of exercise sessions completed per week. determined through completed exercise diaries 4. The number of participant dropouts (attrition rate) is recorded 5. Quantity of missing data (e.g., questionnaire return rate, outcome measures not com | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, mid-intervention (8 weeks), and post-intervention (16 weeks): 1. Anthropometry measured using standard measurement of height, weight and hip and waist circumferences at baseline, mid intervention and post-intervention 2. Body composition measured using bioelectrical impedance analysis at baseline, mid-intervention, immediately post-intervention 3. Clinical parameters (co-morbidities, medication, blood test results) taken from medical notes at baseline, mid-intervention, immediately post-intervention 4. Blood samples for markers of immune function and inflammation and cardiometabolic risk factors taken via venepuncture at baseline, mid-intervention, immediately post-intervention 5. Muscle thickness and cross-sectional area measured via ultrasound imaging at baseline, mid-intervention, and immediately post-intervention 6. Muscle elasticity measured via myotonometery at baseline, mid intervention and immediately post-intervention 7. Physical function measured by the gait speed test, the sit-to-stand test, and timed up and go test at baseline, mid-intervention and immediately post-intervention 8. Isometric and isokinetic quadriceps strength measured using a fixed dynamometer at baseline, mid-intervention and immediately post-intervention 9. Handgrip strength measured using a handheld dynamometer at baseline, mid intervention and immediately post-intervention 10. Postural stability measured over a 30-second period on a force plate at baseline, mid-intervention, and post-intervention 11. Habitual physical activity measured using an accelerometer for 7 days prior to the intervention 12. Dietary behaviours measured by the UK Diabetes and Diet Questionnaire at baseline, mid-intervention and post-intervention | — |
Countries
England, United Kingdom
Outcome results
None listed