Exercise Activity to Improve Mobility in Patients With CKD and PAD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital of Ferrara
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EXERCISE TRAINING WITH OR WITHOUT MEDICATION
BehavioralPatients enrolled in this group will receive a detailed 6-month exercise prescription aimed at providing in-home low fatiguing walking training (at light-moderate intensity, or 2-3 out of 10 of the CR10 Borg\'s scale). The program consists of a two daily 10-minute interval walking sessions (1 minute walking : 1 minute resting) at a prescribed speed controlled by a digital metronome (https://www.youtube.com/watch?v=ki8YX\_t-0jA). The training speed will be set up according to the patients baseline walking capacity (approximately 50% lower than the habitual gait speed) and will be weekly increased until reaching the habitual gait speed. The training time will be maintained constant throughout the entire program. Exercise prescription will be updated during two intermediate hospital visits at the 1st and 3rd months. Patients will be provided with a digital application properly developed to keep pacing and to record the correct training execution.
Control (Standard treatment)
Other interventionPatients enrolled in the Co group will receive standard CKD-PAD care, including optimal medical therapy and nutritional advices
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Exercise groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
6-minute walking test
The patients will be instructed to walk back and forth on a 20-meter corridor aiming at covering as much distance as possible. The total distance covered (6MWD) will be measured in meters
Time frame
Baseline; End of program (6-month); Follow up (12-month)Secondary outcomes
1
Lower limbs perfusion
This measure will be performed according to the published standards with the patient laying by dividing the blood pressure at the ankle with the systolic blood pressure.
Time frame
Baseline; end of the program (6-month); Follow up (12-month).2
handgrip strength will be measured by a standard dynamometer
both hands, patients will be asked to perform three repetitions. The peak and mean values are collected
Time frame
Baseline; end of the program (6-month); Follow up (12-month).3
Quality of life will be assessed by the short-form 36 (SF-36) questionnaire
This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks
Time frame
Baseline; end of the program (6-month); Follow up (12-month).4
Bone mineral density
bone mineral density will be measured through phalangeal quantitative ultrasound with an ultrasound signal of 1.25 MHz frequency and a methodology devoid of X-rays. The results are consistent with those obtained by standard DEXA
Time frame
Baseline; end of the program (6-month); Follow up (12-month).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of Ferrara
Lead sponsor
Universita di Verona
Collaborator
Reggio Calabria
Collaborator
Source ClinicalTrials.gov