Does a supervised exercise program for claudication have an adverse effect on immune, muscle and endothelial function?

In patients with symptomatic lifestyle limiting intermittent claudication, does a 12 week treadmill based supervised exercise program result in changes in endothelial function, body composition and energy expenditure, monocyte subpopulations, apoptosis in muscles, lactadherin expression, and microRNA 92-a expression.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000674730

Enrollment

Registered

2013-06-20

Start date

2013-05-20

Completion date

2014-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with lifestyle limiting intermittent claudication will be offered, in addition to best medical therapy, participation in a 12-week supervised exercise program consisting of two 1 hour sessions per week. The exercise prescription will be based on current evidence of treadmill walking to near maximal pain. They will also undergo two key assessments at baseline (day 0) and at day 90. This will consist of measurement of walking performance (PFWD and 6MWD), body composition (DEXA), resting energy expenditure (calorimetry), endothelial function (FMD and EndoPAT), monocytes and subpopulations (flow cytometry), levels of apoptosis, lactadherin mRNA and protein expression and microRNA-92a expression in ischemic and non-ischemic muscles of the symptomatic leg.

Interventions

Study participants will be identified through the regional claudication clinic and referred to a 12 week exercise program if suitable. Participants will undertake 1 hour of supervised treadmill exercise, twice per week for 12 weeks. The exercise will consist of walking on a treadmill at a speed and incline to bring on leg pain caused by intermittent claudication within 3-5 min. Participants will walk until the point of near maximal pain as per current consensus guidelines. Participants will also be prescribed current best medical therapy and receive advice on smoking cessation. For the first six weeks of the program, six consecutive lectures (30min once per week) by a vascular nurse (Topic: Basics of PAD), physiotherapist (Topic: The benefits of exercise), pharmacist (Topic: Understanding your medications), dietitian (Topic: Eating for cardiovascular health), occupational therapist (Topic: Goal setting, work simplification), and podiatrist (Topic: The importance of foot care.) will be presented.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Symptomatic peripheral arterial disease, namely intermittent calf claudication caused by PAD defined by imaging and ankle-brachial pressure index. Informed consent

Exclusion criteria

No symptomatic peripheral artery disease (normal ABPI or imaging). Thigh and buttock claudication. Exercise tolerance limited by neurological, cardio-pulmonary or rheumatological disability. Therapeutic anticoagulation or blood dyscrasias. Post menopausal women on hormone replacement therapy. Premenopausal women Critical limb ischemia (rest pain or tissue loss) Inability to provide informed consent Patients with recent (<12 months) history of peripheral vascular interventions for symptoms

Outcome results