None listed
Conditions
Brief summary
The goal of the study is to assess changes in claudication walking time measured on treadmill and in community setting outdoor walking after a 12-week supervised treadmill training in patients with claudication. Study participants will be patients with atherosclerosis of lower extremities evaluated according to the Fontaine's classification as degree IIA and IIB recruited from the Department of Internal Medicine, Medical College of the Jagiellonian University in Krakow. 60 patients will be randomised into 2 groups - the exercise group - patients will undergo the 12-week treadmill walking training 3 times a week, the control group will be instructed according to standard preventive recommendations. The treadmill training will be conducted according to TASC II guidelines. Before and after 12 weeks patients will undergo the following examinations: walking ability will be evaluated by a treadmill test and during outdoor walking in community setting; physical activity level. Statistical analysis will be performed with the use of Statistica 10 software. Study has been approved by the research Bioethics Comittee.
Interventions
Patients will participate in 12-week supervised treadmill training 3 times a week. During each exercise session, treadmill walking is performed at a speed 2 mph and individually matched grade that will induce moderate claudication within 3–5 minutes. The initial grade is based on the entry treadmill tests results. Patients should stop walking when claudication pain is considered moderate (moderate pain is a submaximal ischemic pain felt in lower extremity/extremities at level 4 on the 5-point pa
Patients will participate in 12-week supervised treadmill training 3 times a week. During each exercise session, treadmill walking is performed at a speed 2 mph and individually matched grade that will induce moderate claudication within 3–5 minutes. The initial grade is based on the entry treadmill tests results. Patients should stop walking when claudication pain is considered moderate (moderate pain is a submaximal ischemic pain felt in lower extremity/extremities at level 4 on the 5-point pain intensity scale, where 1 = no pain, 2 = onset of claudication, 3 = mild pain, 4 = moderate pain, and 5 = maximal pain). Therefore, the patient starts walking with no pain and after the onset of claudication pain walking is continued until the pain is considered moderate. After exercise, the patient is resting in sitting position until claudication is lessened and then treadmill walking is resumed. Each session of intermittent treadmill walking exercise will be applied for 35 minutes at the start of the program with progressive increase of session time by 5 minutes per 2 weeks. On following sessions the grade of the treadmill will increase when patient is able to walk for 8 minutes or longer on previous workload. Warm up and cool down are not planned. Physical therapist will administrate the intervention. It will be one-on-one face-to-face exercise session. There will be an attendance list to monitor patients adherence to intervention. Also, each walking time on each session will be noted.
Sponsors
Poznan University School of Physical Education, Gorzow Wielkopolski
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patients with atherosclerosis of lower extremities evaluated according to the Fontaine's classification a degree IIA and IIB - Ankle-brachial index < 0.9 - No systemic contraindications to undertake the proposed forms of exercise - Written consent to participate in a clinical trial
Exclusion criteria
Inability to walk on a treadmill at a speed of 2 mph, recently completed vascular treatments (less than 6 months), changes in pharmacological treatment (less than 6 months), symptomatic coronary artery disease, exertional dyspnea, resting blood pressure higher than 160/100 mmHg, resting tachycardia higher than 100 / min, thrombophlebitis, arterial embolism, active cancer, exercise induced asthma, cardio-respiratory failure (NYHA III ).
Outcome results
None listed