Clinical trial NCT06621264: Exercise Activity to Improve Mobility in Patients With CKD and PAD
Official title: EXercise ACTivity to Improve Mobility, Active Behavior and Quality of Life of Chronic Kidney Disease Patients With Peripheral Artery Disease: the EXACTckd-pad Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Stage 3 and 4
Peripheral Artery Disease (PAD)
Keywords: Exercise therapy;
Mobility
Ageing
Chronic Kidney Disease
Peripheral artery disease
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: University of Verona, Italy
name: Reggio Calabria
First posted: 2024-10-01
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People affected by chronic kidney disease and concomitant diagnosed peripheral artery disease at intermediate stages, without contraindications to exercise therapy will be invited to participate in the study.

Whose providing informed consent, will be randomly assigned to one of two groups:

1. Exercise program receiving two daily 10-minute interval walking sessions at a slow increasing speed.
2. Control group: receiving usual care including optimal medical therapy and nutritional advice.

Patients of both groups will be measured at baseline, after the end of the exercise program (6-month) and at follow up (12-month). Outcome measures will include walking ability by the 6-minute walking test (primary outcome) and lower limbs perfusion, body composition, quality of life, laboratory outcomes and long-term hospitalizations.

Detailed description: People with chronic kidney disease (CKD) are exposed to a high risk of developing peripheral artery disease (PAD) and its related adverse health outcomes. This dangerous combination of pathological conditions increases overall cardiovascular risk, mortality and lower limbs amputations.

The scientific literature suggests a strategic co-management of CKD-PAD patients by multidisciplinary teams including specialists of different areas and expertise. Indeed, a common issue is that both these diseases are negatively associated with a sedentary behavior. Exercise therapy may enhance the physical functioning, the risk factors management, the lower limbs vascularization and reduce the cardiovascular risk that affects this population. Since the CKD-PAD population is less likely to be provided recommended optimal care, and considering that 2 out of 3 CKD patients have a completely sedentary behavior for several barriers to training participation, proper exercise programs should be developed. This multicenter randomized-controlled trial aims to test the effectiveness of a 6-month home-based structured walking program on physical functioning and laboratory and clinical outcomes. Purposely 100 CKD patients at KDOQI stages III or IV with concomitant PAD at Rutherford's stages I to III, aged \> 18 years and without absolute contraindications to exercise training will be randomized to receive an exercise intervention (Ex) or usual care (Control, Co). The 6-month training intervention, previously tested in PAD and CKD patients, consist in two 10-minute daily interval walking sessions performed inside the home.

Patients will receive a detailed exercise prescription according to their baseline walking capacity, with the walking speed maintained at home through sound pacing by a digital metronome. The prescribed speed will be weekly increased from the 60 to the 100% of their baseline walking speed with a fixed working time throughout the program. Two serial visits during the program will be scheduled to reinforce adherence to exercise, maintained and verified by a digital application, and to control the blood pressure. Patients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices.

The primary outcome of the study will be the variations of mobility as assessed by the 6-minute walking test at the end of the program. Secondary outcomes will include lower limbs perfusion and strength, body composition and bone mineral density, quality of life, laboratory outcomes including rate of progression of CKD and the long-term hospitalizations and mortality.

Outcome measures will be assessed by blinded operators at baseline, at the end of the program for exercise group (6-month) and at 12 months follow up.

Eligibility criteria: Inclusion Criteria:

* chronic kidney disease at KDOQI stages III or IV and concomitant Peripheral artery disease at stages I, II, III;
* ability to walk independently;
* cognitive function to give informed consent identified by a Mini Mental Status Examination score greater or equal to 20/30
* absence of clinical conditions contraindicating exercise therapy (e.g., unstable angina, severe heart failure at NYHA class IV, anemia with lower than 10.0 g/dl).

Exclusion Criteria:

* major amputations;
* major surgery planned in the next 3 months;
* known comorbid conditions that may limit survival to less than 2 years;
* inability or unwillingness to comply with protocol requirements.

Primary outcomes:
measure: 6-minute walking test
timeFrame: Baseline; End of program (6-month); Follow up (12-month)
Secondary outcomes:
measure: Lower limbs perfusion
timeFrame: Baseline; end of the program (6-month); Follow up (12-month).
measure: handgrip strength will be measured by a standard dynamometer
timeFrame: Baseline; end of the program (6-month); Follow up (12-month).
measure: Quality of life will be assessed by the short-form 36 (SF-36) questionnaire
timeFrame: Baseline; end of the program (6-month); Follow up (12-month).
measure: Bone mineral density
timeFrame: Baseline; end of the program (6-month); Follow up (12-month).
measure: lower limbs strength assessed by the 5-time sit-to-stand test
timeFrame: Baseline; end of the program (6-month); Follow up (12-month).
measure: Body mass index
timeFrame: Baseline, end of the program (6-month); follow up (12-month)
measure: Circulating indexes of kidney function
timeFrame: Baseline, end of treatment (6-month); follow up (12-month)
measure: Long-term survival rate
timeFrame: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
measure: Long-term hospitalizations
timeFrame: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
measure: Rate of admission to dialysis
timeFrame: Baseline, end of treatment (6-month); follow up (12-month); follow up (18-month); Follow up (24-month); FOllow up (36-month)
measure: Pain-free walking distance
timeFrame: Baseline, end of treatment (6-month), follow up (12-month)
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
city: Peschiera del Garda
country: Italy
facility: Ospedale Pederzoli Peschiera del Garda
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
Study officials:
affiliation: Università degli Studi di Ferrara
name: Roberto Manfredini Prof. Roberto Manfredini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: