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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01871779




Registration number
NCT01871779
Ethics application status
Date submitted
31/05/2013
Date registered
7/06/2013
Date last updated
7/06/2013

Titles & IDs
Public title
Effect of Exercise Training on Protein Expression in Skeletal Muscle Tissue After Exercise in Peripheral Arterial Disease
Scientific title
The Effect of Different Forms of Exercise on Both the Clinical, Systemic and Local Biological Responses in Intermittent Claudication
Secondary ID [1] 0 0
CALPAINCLAUD2011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Standard Treadmill Exercise
Other interventions - Intermittent treadmill & resistance training

Experimental: Standard Treadmill Exercise - The first group would undergo standard treadmill exercise to the point of pain and repeat these cycles for a total period of 35-45 minutes twice weekly for 12 weeks

Experimental: Intermittent Treadmill & Resistance Training - The second group would have a combination of intermittent treadmill and some resistance training with weights. They will undergo repeated cycles to a maximum of 35-45 minutes twice weekly for 12 weeks


Other interventions: Standard Treadmill Exercise
Standard treadmill exercise to the point of pain twice weekly for 35-45 minutes for 12 weeks

Other interventions: Intermittent treadmill & resistance training
Combination of standard treadmill training and resistance training with weights twice weekly for 12 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in Pain Free Walking Distance
Timepoint [1] 0 0
Change from baseline (pre intervention) to 12 weeks (post intervention)
Secondary outcome [1] 0 0
Skeletal muscle protein expression
Timepoint [1] 0 0
Change from baseline (pre intervention) to 12 weeks (post intervention)
Secondary outcome [2] 0 0
Inflammatory cytokines
Timepoint [2] 0 0
Change from baseline (pre intervention) to 12 weeks (post intervention)
Secondary outcome [3] 0 0
Endothelial function
Timepoint [3] 0 0
Change from baseline (pre intervention) to 12 weeks (post intervention)

Eligibility
Key inclusion criteria
1. All claudicants with a walking distance of 50 metres or more with a resting ankle
brachial index equal to or less than 0.9.

2. Claudicants meeting above criteria, who may have previously had a percutaneous
arterial intervention for symptom control more than 12 months ago.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with lower limb pain of other aetiologies - neurogenic claudication evidenced
by normal ankle brachial indices and duplex ultrasound.

2. Patients with lower limb ischaemic rest pain

3. Patients with current or previous tissue loss, such as ulcers or necrotic lesions.

4. Patients with recent (<12 months) history of peripheral vascular interventions for
symptoms.

5. Patients with pre-existing cardiac or respiratory problems limiting exercise.

6. Patients with previous disabling strokes which would restrict exercise regimes

7. Patients with anticoagulation or blood dyscrasias.

8. Women who are pre-menopausal,

9. Women receiving hormone-replacement therapy.

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Repatriation General Hospital - Daw Park
Recruitment postcode(s) [1] 0 0
5041 - Daw Park

Funding & Sponsors
Primary sponsor type
Other
Name
Flinders University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders Medical Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Adelaide Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Queen Elizabeth Hospital
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Cardiovascular disease remain one of the leading causes of death in Australia, accounting for
47637 (36%) of deaths in 2004.

Peripheral arterial disease (PAD) is a category of cardiovascular disease, characterised by
intermittent claudication. This is defined as walking induced pain, cramping, aching,
tiredness or heaviness in one or both legs that does not go away with continued walking and
is relieved with rest. It is estimated that between 5-10% of individuals aged over 50 years
suffer from claudication. The primary and most effective treatment for these patients is
focused on improving walking ability and functional status.

Current research has shown that approximately 30% of patients improve with exercise, while
30% continue to deteriorate and the rest show no change. The changes produced at a
biochemical and cellular level due to exercise are unknown. To help better understand this,
our study will assess the entire range of proteins expressed before and after exercise in the
skeletal muscle tissue of patients with intermittent claudication. This will help to
identifying key proteins that have a role in improving patient symptoms and outcome.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01871779
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher L Delaney, BMBS
Address 0 0
Flinders University and Flinders Medical Centre Department of Vascular Surgery
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01871779