Exercise R01 Venous Ulcers

iHealth Exercise Intervention for Leg Ulcers: A Randomized Clinical Trial : 

iHealth Exercise Intervention for Leg Ulcers: A Randomized Clinical Trial Teresa J. Kelechi, PhD, RN Associate Professor College of Nursing

R01 : 

R01 To be submitted to National Institute of Nursing Research on February 5, 2010 New submission responding to: PA – 09 -125 or 07 (new announcement in December) Biobehavioral Methods to Improve Outcomes Research

What is known? : 

What is known? 8 out of 100 adults with chronic venous disorders (CVDs) develop a leg ulcer each year 72% re-ulcerate within 3 months to one year 7 – 10 leg ulcers in a lifetime $3 billion costs of care

Slide 4: 

CVD Pathology Venous hypertension Stages 4 & 5: -Eczema -Pigmentation -Lipodermatosclerosis -Atrophie Blanche -History of leg ulcers

Why bother? : 

Why bother? Need to improve treatments for leg ulcers Standard of care: Compression Elevation Exercise Skin care

Problem : 

Problem Chronic venous disorders (CVDs) contribute to venous leg ulcers (VLUs) Ineffective calf pump,  ankle range of motion = severe CVDs and VLUs Walking and toe lift exercises are ideal to pump calf Many people cannot walk due to reduce function, obesity, neuropathy, venous claudication, and environment barriers Adherence to lower extremity exercise is low

Purpose : 

Purpose Deliver a XXX week home-based structured exercise bundle via an iHealth (internet-interactive-telehealth) videoconferencing technology to improve adherence Live interactive coaching Online streaming exercise videos (different levels of difficulty) ?????? Online group support and education ????? Individuals can chose from multiple exercise options

Organizing hypotheses : 

Organizing hypotheses iHealth intervention will: H1: improved biophysical markers: calf muscle pump function, lower limb muscle strength, ankle range of motion, ulcer healing rates, physical function H2: reduced abnormal circulation markers: skin temperature, blood flow, swelling H3: improved quality of life, exercise adherence, and reduced pain

Goal : 

Goal To change biophysical markers: Group 1 – exercise intervention + usual care Group 2 – usual care Subjects: adults, 21 and above, open leg ulcers (could also include those with history) Setting: patients’ homes

Aims : 

Aims The primary aim is to test the efficacy of iHealth compared to usual care in XXX people with Stage 6 CVDs (open venous leg ulcers) randomized to the internet live coach or written instructions. Specifically: An internet live coach exercise intervention (iHealth) will be delivered over XX weeks intervention, XX weeks intense weekly follow-up, XX weeks monthly follow-up in the patient’s home compared to the guideline-guided UC intervention (handout on exercise instructions).

Intervention . . . . : 

Intervention . . . .

Methods : 

Methods Measures Chronic Venous Disorders (CVD) CEAP Stages C6: open leg ulcer Randomized to: iHealth exercise (n=XX) or usual exercise (n=XX) Biophysical Physical function, strength, calf function, swelling Adherence Demographic (Health history, QOL) Questionnaires: -VEINES-QOL/Sym -Activities of Living / Leg Pain -Pain Visual Analog Devices/instruments: -Air plethysmography -Digital goniometry -Laser Doppler flowmeter -XXX physical function Adherence questionnaire: Tracking logs Fidelity Safety Tolerability Physical function Quality of life and pain Adherence, safety, tolerability Leg ulcer healing rates Swelling, skin temperature, blood flow, calf function, ROM Data Sources Outcomes Inclusion criteria

Statistical analysis : 

Statistical analysis Sample size To be determined Analysis - unadjusted mean differences: ANOVA - adjusted mean differences: general linear models - longitudinal: mixed effects models

Visits : 

Visits Four visits: ????? Baseline Month 3 Month 6 Month 12

Investigative team : 

Investigative team Collaborators (Internal): Dr. Steve Blair Biostatistics: Dr. Martina Mueller, PhD Health Services Research: Dr. Jane Zapka, ScD Wound expert: Dr. Phyllis Bonham, PhD ??? Telehealth expert ??? Consultants (External): Telehealth expert Vascular expert

Previous study findings by PI : 

Previous study findings by PI #1 Skin temperature higher by 3.2°C #2 Skin temperature and blood flow higher, oxygen lower (R15 – NINR) #3 No hour-to-hour and day-to-day skin temperature variations #4 Gel wrap cryotherapy + leg elevation significantly reduced blood flow (R21 – NINR)

Challenges and potential problems : 

Challenges and potential problems Found use of the internet “skype” feasible but sample very small Adults with healed leg ulcers: Should this population also be included? What type of lower limb exercises are best? What type of equipment is needed? How to measure physical function (exercise science literature)

Innovation : 

Innovation Deliver the intervention where a coach can see and interact with the patient in “real-time” Provides access to exercise for chronically ill population with functional problems, access barriers, and limited resources If successful, could be used in clinical settings for example, when a patient comes for wound care Can be accessed ANYTIME and from ANYWHERE All exercises done while seated

Summary of innovation : 

Summary of innovation Apply existing technologies (internet) to individuals who would not traditionally participate in the health-promoting behavior of exercise: Need: to improve physical activity/exercise and promote health Unconventional: measure adherence and acceptability using technology Exceptionally innovative: use live coaching/support/education- can see and interact in real-time – progress can be observed and modifications made Match strategies with population demographics to tailor approaches

Significance : 

Significance Limited research on exercise to improve healing What is the literature on use of internet to exercise? Behavioral issues with adherence?

Significance : 

Significance Need to demonstrate efficacy of an internet delivered exercise intervention that speeds VLU healing, improves the quality of life, etc. Long-term goal is to reduce unnecessary health care utilization by thousands of afflicted people.

Conclusion : 

Conclusion The people in this study are poor candidates for surgical or pharmacologic intervention due the severity of the disease process or co-morbidities, or they have failed these therapies in the past. Because the monetary and human suffering costs are great, new methods to improve patient outcomes are critical.