Effect of Exercise Training on Protein Expression in Skeletal Muscle Tissue After Exercise in Peripheral Arterial Disease

NCT01871779 | Completed

• 1 other identifier: CALPAINCLAUD2011
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Improvement in Pain Free Walking Distance

  Patients will be exercised based on standard protocols and monitored for improvements in Maximal walking distance and Pain Free Walking distances.

  Change from baseline (pre intervention) to 12 weeks (post intervention)

Secondary Outcomes (3)

• Skeletal muscle protein expression

  Change from baseline (pre intervention) to 12 weeks (post intervention)

• Inflammatory cytokines

  Change from baseline (pre intervention) to 12 weeks (post intervention)

• Endothelial function

  Change from baseline (pre intervention) to 12 weeks (post intervention)

Study Arms (2)

Standard Treadmill Exercise

EXPERIMENTAL

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

Other: Standard Treadmill Exercise

Intermittent Treadmill & Resistance Training

EXPERIMENTAL

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: Intermittent treadmill & resistance training

Interventions

Standard Treadmill Exercise OTHER

Standard treadmill exercise to the point of pain twice weekly for 35-45 minutes for 12 weeks

Standard Treadmill Exercise

Intermittent treadmill & resistance training OTHER

Combination of standard treadmill training and resistance training with weights twice weekly for 12 weeks

Intermittent Treadmill & Resistance Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All claudicants with a walking distance of 50 metres or more with a resting ankle brachial index equal to or less than 0.9.
• Claudicants meeting above criteria, who may have previously had a percutaneous arterial intervention for symptom control more than 12 months ago.

You may not qualify if:

• Patients with lower limb pain of other aetiologies - neurogenic claudication evidenced by normal ankle brachial indices and duplex ultrasound.
• Patients with lower limb ischaemic rest pain
• Patients with current or previous tissue loss, such as ulcers or necrotic lesions.
• Patients with recent (\<12 months) history of peripheral vascular interventions for symptoms.
• Patients with pre-existing cardiac or respiratory problems limiting exercise.
• Patients with previous disabling strokes which would restrict exercise regimes
• Patients with anticoagulation or blood dyscrasias.
• Women who are pre-menopausal,
• Women receiving hormone-replacement therapy.

Sponsors & Collaborators

• Flinders University: lead
• Flinders Medical Centre: collaborator
• Royal Adelaide Hospital: collaborator
• The Queen Elizabeth Hospital: collaborator

Study Sites (1)

Repatriation General Hospital

Daw Park, South Australia, 5041, Australia

Location

Related Publications (1)

• Delaney CL, Miller MD, Dickinson KM, Spark JI. Change in dietary intake of adults with intermittent claudication undergoing a supervised exercise program and compared to matched controls. Nutr J. 2014 Oct 15;13:100. doi: 10.1186/1475-2891-13-100.

  PMID: 25316347 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christopher L Delaney, BMBS

  Flinders University and Flinders Medical Centre Department of Vascular Surgery

  PRINCIPAL INVESTIGATOR

• James I Spark, MBChB, MD,

  Flinders University and Flinders Medical Centre Department of Vascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 7, 2013
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

AU (1)