The EX-FRAIL CKD Trial

The EX-FRAIL CKD Trial: a pilot mixed methods randomised controlled trial of a home-based EXercise programme for pre-FRAIL and FRAIL, older adults with Chronic Kidney Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87708989

Enrollment

Registered

2018-08-30

Start date

2018-09-03

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty in people with chronic kidney disease Urological and Genital Diseases

Interventions

Interventions as of 31/10/2018: Eligible participants will initially have a Frailty Phenotype assessment performed. Only those meeting the definitions for pre-frailty and frailty when assessed by the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 28/03/2019: 1. Participants must be able to give informed consent 2. Participants must be =65 years of age 3. Participants must have CKD stage 3b, 4 or 5 (not receiving dialysis or received a kidney transplant). 4. Participants are assessed as vulnerable or frail using the Clinical Frailty Scale (score =4) Previous participant inclusion criteria: 1. Participants must be able to give informed consent 2. Participants must be =65 years of age 3. Participants must have CKD stage 4 or 5 (not receiving dialysis or received a kidney transplant) 4. Participants are assessed as vulnerable or frail using the Clinical Frailty Scale (score =4)

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 28/03/2019: 1. Unstable Angina or recent (within the last 3 months) myocardial infarction 2. Recent (within the last 3 months) stroke or transient ischaemic attacks 3. Uncontrolled arrhythmias 4. Persistent uncontrolled hypertension (systolic blood pressure >180 or diastolic blood pressure >110) 5. Registered blind 6. Unable to mobilise independently 7. Receiving palliative care for advanced terminal cancer 8. Recently (within the last 12 months) enrolled in a structured exercise programme (e.g. cardiac rehabilitation programme) prescribed by a health professional 9. Anticipated to commence dialysis or receive a renal transplant within the next 3 months 10. Insufficient understanding of English language to complete study questionnaires or follow advice within the EX-FRAIL CKD Trial Exercise Guidebook 11. Clinical and/or Research Team consider participation in the EX-FRAIL CKD Trial exercise programme unsafe. Previous participant exclusion criteria as of 31/10/2018: 1. Unstable Angina or recent (within the last 3 months) myocardial infarction 2. Recent (within the last 3 months) stroke or transient ischaemic attacks 3. Uncontrolled arrhythmias 4. Persistent uncontrolled hypertension (systolic blood pressure >180 or diastolic blood pressure >110) 5. Registered blind 6. Unable to mobilise independently 7. Receiving palliative care 8. Recently (within the last 12 months) enrolled in a structured exercise programme (e.g. cardiac rehabilitation programme) prescribed by a health professional 9. Anticipated to commence dialysis or receive a renal transplant within the next 3 months 10. Insufficient understanding of English language to complete study questionnaires or follow advice within the EX-FRAIL CKD Trial Exercise Guidebook 11. Clinical and/or Research Team consider participation in the EX-FRAIL CKD Trial exercise programme unsafe. Previous participant exclusion criteria: 1. Unstable Angina or recent (within the last 3 months) myocardial infarction 2. Recent (within the last 3 months) stroke or transient ischaemic attacks 3. Uncontrolled arrhythmias 4. Persistent uncontrolled hypertension (systolic blood pressure >180 or diastolic blood pressure >110) 5. Registered blind 6. Unable to mobilise independently 7. Receiving palliative care 8. Recently (within the last 12 months) enrolled in a structured exercise programme (e.g. cardiac rehabilitation programme) prescribed by a health professional 9. Anticipated to commence dialysis or receive a renal transplant within the next 3 months 10. Insufficient understanding of English language to complete study questionnaires or follow advice within the EX-FRAIL CKD Trial Exercise Guidebook

Design outcomes

Primary

Measure	Time frame
1. Proportion of patients attending General Nephrology Clinics eligible for Frailty Phenotype assessment 2. Proportion of participants randomised to the exercise programme who complete at least two exercise sessions per week during the 12-week exercise programme 3. Proportion of participants who adhere to the exercise programme that complete all outcome assessments 4. Semi-structured, individual interviews will be performed with a purposively selected group of participants from both groups. A representative sample (based on age, gender and frailty status) of participants will be asked a series of open-ended questions relating to their experience of the trial and, where applicable, the intervention	—

Measure

Time frame

1. Proportion of patients attending General Nephrology Clinics eligible for Frailty Phenotype assessment 2. Proportion of participants randomised to the exercise programme who complete at least two exercise sessions per week during the 12-week exercise programme 3. Proportion of participants who adhere to the exercise programme that complete all outcome assessments 4. Semi-structured, individual interviews will be performed with a purposively selected group of participants from both groups. A representative sample (based on age, gender and frailty status) of participants will be asked a series of open-ended questions relating to their experience of the trial and, where applicable, the intervention

—

Secondary

Measure	Time frame
There were no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026