Authors
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Smith, Alice, Wilkinson, Thomas J -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2020
INTERVENTION: 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 provide a diverse cross‐sectional sample of kidney disease patients and the prevalence and impact of sarcopenia using self‐reported measures. Using informal semi‐structured interviews, Part B will involve a greater in‐depth exploration of the experiences towards sarcopenia and the potential role of home‐based resistance training in patients with kidney disease. In Part C (intervention development), the researchers will recruit a small number of individuals with kidney disease to undergo some iterative testing of a home‐based resistance exercise intervention. This will primarily test and optimise the ‘exercise prescription’ session that will take place before the intervention itself. This will include testing of some potential exercises and how patients are able to complete them. This developmental aspect will continue until the intervention is ready for testing and will ensure the final intervention has the greatest chance of succeeding. In Part D (exercise intervention), we will test the feasibility of a home‐based progressive resistance exercise training in patients with kidney disease. Participants can complete any of the four parts of the study, or end their involvement after taking part in just one. Part A Part A will involve a cross‐sectional observational design. Participants will be asked to complete a brief survey that will assess self‐reported sarcopenia status in CKD. The researchers aim to recruit at least n=200 participants into Part A. This may be extended at a later stage if required. Patients will be recruited from CONDITION: Chronic kidney disease ; Urological and Genital Diseases ; Chronic kidney disease SECONDARY OUTCOME: ; 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; PRIMARY OUTCOME: ; 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 completed) monitored via the clinical research file; 6. Safety monitored by self‐reported injuries and adverse events throughout the trial; 7. Patient experience explored through qualitative interviews at variable timepoints before, during and after the intervention; 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
Epistemonikos ID: e279e107b48e7cef308e8899fae61e9d3cdd0e42
First added on: Dec 16, 2022