Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000243415
Ethics application status
Approved
Date submitted
23/11/2015
Date registered
22/02/2016
Date last updated
9/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects of supervised treadmill walking training and supervised walking with poles on functional capabilities in patients with intermittent claudication
Scientific title
Comparison of the effects of supervised treadmill walking training and supervised walking with poles on the functional capabilities, the function of endothelium and the metabolic cost of walking in patients with intermittent claudication.
Secondary ID [1] 287958 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intermittent claudication 296835 0
atherosclerosis 296836 0
Condition category
Condition code
Cardiovascular 297066 297066 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293302 0
Rehabilitation
Intervention code [2] 293494 0
Treatment: Other
Comparator / control treatment
The control group will be instructed according to standard preventive recommendation and will not undergo walking training.
Control group
Active

Outcomes
Primary outcome [1] 296671 0
Maximal walking distance (Treadmill test, Gardner protocol)
Timepoint [1] 296671 0
baseline and after 12 weeks
Primary outcome [2] 296674 0
Vascular endothelial function - method of determining the degree of dilatation of the brachial artery - FMD flow mediated dilatation
Timepoint [2] 296674 0
baseline and after 12 weeks
Primary outcome [3] 296675 0
Metabolic cost of walking determined using oxygen consumption measure (Graded treadmill walking test with simultaneous breath-by-breath Vo2 measurements)
Timepoint [3] 296675 0
baseline and after 12 weeks
Secondary outcome [1] 319086 0
Pain-free walking distance' (Treadmill test, Gardner protocol)
Timepoint [1] 319086 0
baseline and after 12 weeks
Secondary outcome [2] 320649 0
Assessment of functional walking ability (WIQ - Walking Impairment Questionnaire)
Timepoint [2] 320649 0
baseline and after 12 weeks

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 ).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
20/03/2018
Actual
20/03/2018
Date of last data collection
Anticipated
Actual
20/06/2018
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 7351 0
Poland
State/province [1] 7351 0

Funding & Sponsors
Funding source category [1] 292433 0
University
Name [1] 292433 0
University School of Physical Education in Krakow
Country [1] 292433 0
Poland
Primary sponsor type
University
Name
University School of Physical Education in Krakow
Address
University School of Physical Education in Krakow, Aleja Jana Pawla II 78, 31-571 Krakow
Country
Poland
Secondary sponsor category [1] 291127 0
None
Name [1] 291127 0
Address [1] 291127 0
Country [1] 291127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293893 0
Bioethics committee - Regional Medical Chamber in Krakow
Ethics committee address [1] 293893 0
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Krakowie, ul. Krupnicza 11a, 31-123 Krakow
Ethics committee country [1] 293893 0
Poland
Date submitted for ethics approval [1] 293893 0
Approval date [1] 293893 0
10/04/2013
Ethics approval number [1] 293893 0
30/KBL/OIL/2013

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 643 643 0 0
/AnzctrAttachments/369663-zgoda komisji bioetycznej.pdf

Contacts
Principal investigator
Name 61710 0
Miss Ewelina Rosloniec
Address 61710 0
Akademia Wychowania Fizycznego w Krakowie
Zawodzie 1a/18, 31-232 Krakow
Country 61710 0
Poland
Phone 61710 0
+48 518494666
Fax 61710 0
Email 61710 0
[email protected]
Contact person for public queries
Name 61711 0
Miss Ewelina Rosloniec
Address 61711 0
Akademia Wychowania Fizycznego w Krakowie
Zawodzie 1a/18, 31-232 Krakow
Country 61711 0
Poland
Phone 61711 0
+48 518494666
Fax 61711 0
Email 61711 0
[email protected]
Contact person for scientific queries
Name 61712 0
Miss Ewelina Rosloniec
Address 61712 0
Akademia Wychowania Fizycznego w Krakowie
Zawodzie 1a/18, 31-232 Krakow
Country 61712 0
Poland
Phone 61712 0
+48 518494666
Fax 61712 0
Email 61712 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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