Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000499280
Ethics application status
Approved
Date submitted
11/02/2018
Date registered
6/04/2018
Date last updated
6/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in Walking Abilities Measured on Treadmill and in Community Setting Outdoor Walking After a 12-Week Supervised Treadmill Training in Patients with Claudication.
Scientific title
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.
Secondary ID [1] 294017 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atherosclerosis
306539 0
intermittent claudication 306540 0
Peripheral vascular disease 306914 0
Condition category
Condition code
Cardiovascular 305641 305641 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300288 0
Rehabilitation
Intervention code [2] 300289 0
Treatment: Other
Comparator / control treatment
The control group will be instructed according to standard preventive recommendation (based on TASC II guidelines for modification of risk factors for Peripheral Arterial Disease and ACSM guidelines for adult exercise) and will not undergo walking training.
Control group
Active

Outcomes
Primary outcome [1] 304750 0
Maximal walking distance (Treadmill test, Gardner protocol)
Timepoint [1] 304750 0
baseline and 12 weeks after commencement of intervention
Primary outcome [2] 304751 0
Highest measured walking distance (community settings outdoor test with GPS device, the HMD was determined as the highest distance between two stops induced by lower extremity pain)
Timepoint [2] 304751 0
baseline and 12 weeks after commencement of intervention
Secondary outcome [1] 343005 0
physical activity level (accelerometer-based physical activity monitoring; questionnaire - International Physical Activity Questionnaire (IPAQ) – Polish version)
Timepoint [1] 343005 0
baseline,
accelerometer will be worn on nondominant wrist during 7 consecutive days

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 9576 0
Poland
State/province [1] 9576 0

Funding & Sponsors
Funding source category [1] 298639 0
University
Name [1] 298639 0
Poznan University School of Physical Education, Gorzow Wielkopolski
Country [1] 298639 0
Poland
Primary sponsor type
University
Name
Poznan University School of Physical Education, Gorzow Wielkopolski
Address
Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski
Country
Poland
Secondary sponsor category [1] 297812 0
None
Name [1] 297812 0
Address [1] 297812 0
Country [1] 297812 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299599 0
Bioethics committee - Poznan University of Medical Sciences
Ethics committee address [1] 299599 0
Komisja Bioetyczna przy Uniwersytecie Medycznym im. Karola Marcinkowskiego w Poznaniu, ul. Bukowska 70, pok A204, 60-812 Poznan
Ethics committee country [1] 299599 0
Poland
Date submitted for ethics approval [1] 299599 0
Approval date [1] 299599 0
09/04/2015
Ethics approval number [1] 299599 0
387/15

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80978 0
Dr Anita Kulik
Address 80978 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6
66-400 Gorzow Wielkopolski
Country 80978 0
Poland
Phone 80978 0
+48957279222
Fax 80978 0
Email 80978 0
a.kulik@awf-gorzow.edu.pl
Contact person for public queries
Name 80979 0
Anita Kulik
Address 80979 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6
66-400 Gorzow Wielkopolski
Country 80979 0
Poland
Phone 80979 0
+48957279222
Fax 80979 0
Email 80979 0
a.kulik@awf-gorzow.edu.pl
Contact person for scientific queries
Name 80980 0
Anita Kulik
Address 80980 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6
66-400 Gorzow Wielkopolski
Country 80980 0
Poland
Phone 80980 0
+48957279222
Fax 80980 0
Email 80980 0
a.kulik@awf-gorzow.edu.pl

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No Supporting Document Provided



Results publications and other study-related documents

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