None listed
Conditions
Brief summary
The aim of a study is to evaluate changes in walking ability, the function of endothelium and the metabolic cost of walking in patients with intermittent claudication that undergo 12-week supervised treadmill walking training and 12-week supervised walking training with poles. 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. 90 patients will be randomised into 3 groups - 1-patients will undergo the 12-week treadmill walking training 3 times a week, 2- patients will undergo the 12-week walking with poles training 3 times a week and the control group will be instructed according to standard preventive recommendations. The treadmill training will be conducted according to TASC II guidelines. Walking training with poles will last approximately 1 hour. Before and after 12 weeks patients will undergo the following examinations: walking ability will be evaluated by a treadmill test, oxygen uptake and metabolic cost of walking will be measured during graded treadmill walking test with simultaneous breath-by-breath VO2 measurements. Vascular endothelial function will be assessed by using non-invasive method of determining the degree of dilatation of the brachial artery FMD. Statistical analysis will be performed with the use of Statistica 10 software. Study has been approved by the research Bioethics Comittee.
Interventions
Patients will undergo 12-week supervised treadmill walking training 3 times a week (group A) and 12-week supervised walking training with poles 3 times a week (group B).
Supervised walking training with poles will take place in a park. One session of walking with poles will last approximately 1 hour. GPS watches with compatible heart rate monitors will be used to track distance, time and pace of walking and monitor heart rate.
Supervised walking treadmill training will be conducted indoors ac
Patients will undergo 12-week supervised treadmill walking training 3 times a week (group A) and 12-week supervised walking training with poles 3 times a week (group B). Supervised walking training with poles will take place in a park. One session of walking with poles will last approximately 1 hour. GPS watches with compatible heart rate monitors will be used to track distance, time and pace of walking and monitor heart rate. Supervised walking treadmill training will be conducted indoors according to TASC II guidelines (beginning with 30 minutes of training but then increasing to approximately 1 hour per session - extending 5 minutes every 2 weeks). All the interventions are administered on an individual basis according to the entry treadmill tests results. During the exercise session, treadmill exercise is performed at a speed and grade that will induce claudication within 3–5 minutes. 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 developed by the American College of Sports Medicine ACSM). Level 2 in the scale: Start of claudication may be described as pain, ache, cramping, a sense of fatigue, or nonspecific discomfort felt in lower extremity/extremities that occurs with exercise. The patient will then rest until claudication has abated, after which the patient should resume walking until moderate claudication discomfort recurs. Target exercise intensity for each group: 65-75% maximal heart rate. Physical therapist will be administering the intervention.
Sponsors
University School of Physical Education in Krakow
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
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