Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000780853
Ethics application status
Approved
Date submitted
4/03/2020
Date registered
22/06/2021
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Date results provided
22/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of physical rehabilitation on muscle function and gait parameters of patients with intermittent claudication.
Scientific title
Development of a rehabilitation program for patients with chronic lower limb ischemia based on the study of biomechanics of movement, muscle strength and other objective methods of assessing the improvement of their functioning.
Secondary ID [1] 300641 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
peripheral artery disease 316420 0
Intermittent claudication 316421 0
Condition category
Condition code
Physical Medicine / Rehabilitation 314681 314681 0 0
Physiotherapy
Cardiovascular 314682 314682 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients participated in 12 weeks of training under the supervision of a physiotherapist and physician. The subjects were assigned to one of three rehabilitation programs (3 times a week) using the pseudorandomisation method (consecutive patients were assigned to one group or the other: group I - standard walking training on a treadmill (TT); group II - Nordic walking (NW) training; group III - strength and endurance training comprised of NW combined with isokinetic strength training (NW + ISO).
The mode of administration: group I - one-on-one, group II - groups of 10, group III - groups of 10 and one-on-one (mixed).

Standard Treadmill Test, 6 Minute Walk Test (6MWT), isokinetic test with sEMG and biochemical parameters were repeated after 3 months of rehabilitation, which 80 people completed.
The degree of subjective level of fatigue was assessed according to Borg’s 10-degree scale.
To assess adherence to the intervention we used attendance checklists and monitor heart ratio. Final analysis excluded patients who attended fewer than <75% training sessions.

Intervention code [1] 316972 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Active

Outcomes
Primary outcome [1] 323005 0
Maximal walking distance (Standard Treadmill Test)
Timepoint [1] 323005 0
baseline and 12 weeks of intervention
Primary outcome [2] 323006 0
Assessment of lower limb strength (isokinetic): flexor and extensor muscles of the knee joint and dorsal and plantar flexor muscles of the ankle joint using a functional dynamometer (Biodex System 4 Pro).
Timepoint [2] 323006 0
baseline and 12 weeks of intervention
Primary outcome [3] 323007 0
Assessment of spatiotemporal gait parameters. In order to record kinematic and kinetic parameters of gait, an optoelectronic BTS Smart-E system for three-plane motion analysis (BTS Bioengineering Corp., Quincy, USA) was used, The set up was supplemented with two dynamometric Kistler 9286 platforms (Kistler Group, Winterthur, Switzerland). Prior to each test, 22 passive photo-reflective markers were attached to the patient’s body, corresponding to selected anthropometric points in accordance with the Davis protocol. A digitally processed image from the cameras enabled the measurement of mean gait velocity (velMEAN [m/s]), number of steps per minute (CADENCE [step/min]), stride length and stride width (length STRIDE [m] and width STRIDE [m]), stride and swing velocity (velSTRIDE [m/s] and velSWING [m/s]), stride time for the swing and stance phases (tSTRIDE [s], tSWING [s] and tSTANCE [s]) and double stride time (tdoubleSTRIDE R [s]). A three-plane measurement of ground reaction forces was used to analyse vertical loading during initial contact (VEmax1), loading response (VEmin) and toe-off (VEmax2), in addition to the anteroposterior (AP) load distribution (APmax and APmin) and mediolateral (ML) load distribution (MLmax and MLmin). For further analysis, ground force responses were also presented as a percentage of body weight [% BW].
Timepoint [3] 323007 0
baseline and 12 weeks of intervention
Secondary outcome [1] 380508 0
Assessment of physical function - 6 Minute Walk Test (6MWT)
Timepoint [1] 380508 0
baseline and 12 weeks of intervention
Secondary outcome [2] 380509 0
Assessment of muscle activity (sEMG). Muscles were assessed: vastus medialis, rectus femoris, gastrocnemius medialis, tibialis anterior.
Timepoint [2] 380509 0
baseline and 12 weeks of intervention
Secondary outcome [3] 380510 0
Assessment of neopterin level in the blood
Timepoint [3] 380510 0
baseline and 12 weeks of intervention
Secondary outcome [4] 380790 0
Assessment of homocystein level in the blood
Timepoint [4] 380790 0
baseline and 12 weeks of intervention
Secondary outcome [5] 380791 0
Assessment of CRP in the blood
Timepoint [5] 380791 0
baseline and 12 weeks of intervention
Secondary outcome [6] 380792 0
Assessment of TG mg/dL in the blood
Timepoint [6] 380792 0
baseline and 12 weeks of intervention
Secondary outcome [7] 380793 0
Assessment of TC mg/dL level in the blood
Timepoint [7] 380793 0
baseline and 12 weeks of intervention
Secondary outcome [8] 380794 0
Assessment of LDL mg/dL level in the blood
Timepoint [8] 380794 0
baseline and 12 weeks of intervention
Secondary outcome [9] 380795 0
Assessment of HDL mg/dL level in the blood
Timepoint [9] 380795 0
baseline and 12 weeks of intervention
Secondary outcome [10] 380796 0
Assessment of non-HDL mg/dL level in the blood
Timepoint [10] 380796 0
baseline and 12 weeks of intervention
Secondary outcome [11] 380797 0
Assessment of RC mg/dL level in the blood
Timepoint [11] 380797 0
baseline and 12 weeks of intervention

Eligibility
Key inclusion criteria
- over 50 years of age
- documented PAD and lower-limb ischaemia
- intermittent claudication distance of 30-400 meters (Fontaine’s classification IIa and IIb) stable for at least 3 months
- ABI<0.9
- sound clinical condition of the patient
- written consent of the patient to participate in the project
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- PAD Fontaine stage I (painless distance, no impairment of walking capacity)
- Fontaine stage III/IV (pain at rest / trophic ulcer)
- uncontrolled arterial hypertension and/or diabetes, decompensated congestive heart failure
- level of subjective fatigue above 7 points according to the 10-point Borg scale
- cardiovascular incidents (MI, stroke) in the last year prior to the rehabilitation program
- revascularization procedures performed during the last 3 months
- generally poor patient health, incapacity to perform functional tests in motor terms
- mental illness, and participation in another scientific research program

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
8/06/2015
Date of last data collection
Anticipated
Actual
20/10/2015
Sample size
Target
95
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 22378 0
Poland
State/province [1] 22378 0
Wroclaw

Funding & Sponsors
Funding source category [1] 305065 0
Government body
Name [1] 305065 0
The National Centre for Research and Development
Country [1] 305065 0
Poland
Primary sponsor type
Hospital
Name
WROVASC - Integrated Center for Cardiovascular Medicine
Address
Wojewódzki Szpital Specjalistyczny we Wroclawiu
Osrodek Badawczo-Rozwojowy
ul. H. M. Kamienskiego 73a
51-124 Wroclaw
Country
Poland
Secondary sponsor category [1] 305516 0
None
Name [1] 305516 0
Address [1] 305516 0
Country [1] 305516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305452 0
Ethics Committee of Wroclaw Medical University
Ethics committee address [1] 305452 0
Ethics committee country [1] 305452 0
Poland
Date submitted for ethics approval [1] 305452 0
Approval date [1] 305452 0
27/03/2008
Ethics approval number [1] 305452 0
KB-130/2008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100434 0
Prof Andrzej Szuba
Address 100434 0
University Clinical Hospital in Wroclaw ul.Borowska 213 50-556 Wroclaw
Country 100434 0
Poland
Phone 100434 0
+0048717332200
Fax 100434 0
Email 100434 0
[email protected]
Contact person for public queries
Name 100435 0
Katarzyna Bulinska
Address 100435 0
University School of Physical Education in Wroclaw al. Ignacego Jana Paderewskiego 35 51-612 Wroclaw
Country 100435 0
Poland
Phone 100435 0
+0048713473522
Fax 100435 0
Email 100435 0
[email protected]
Contact person for scientific queries
Name 100436 0
Wioletta Dziubek-Rogowska
Address 100436 0
University School of Physical Education in Wroclaw al. Ignacego Jana Paderewskiego 35 51-612 Wroclaw
Country 100436 0
Poland
Phone 100436 0
+0048713473522
Fax 100436 0
Email 100436 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Immediately after the publication of the material in the journal. End-date of availability: 6 months from publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• requirement to sign data access agreement; data will be made available by emailing the investigator: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7078Ethical approval    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.