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Impact of simulated weight reduction on pain in foot and ankle arthritis

Short Study Title:
Impact of simulated weight reduction on pain in foot and ankle arthritis

Protocol No.
v1 22.12.2015

Description:
Anti-gravity simulated weight reduction: a pilot study to assess the impact upon pain for foot and ankle arthritis.

REC reference:
16/WA/0030

Sponsor(s):
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

IRAS Project ID:
198374

Funder(s):
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Geographical Scope:
Single Centre

Disease Area:
Symptomatic end stage foot and ankle arthritis and raised BMI

Sample Size:
20

Study Type:
Observational

Study Design:
Non randomised

Estimated Closure Date:
31/07/2016

Current Status:
Open to recruitment

Inclusion Criteria:
≥18 years of age.
Able to provide informed consent.
Osteoarthritis affecting the midfoot, hindfoot or ankle.
BMI >30.
No significant cardiovascular disease or NYHA class 1.
Significant pain and/or loss of function requiring surgical intervention.
Able to walk on a treadmill.

Exclusion Criteria:
<18 years of age
Unable to give informed consent.
Cardiovascular disease or respiratory compromise limiting exercise tolerance (NYHA class 2 or above).
Symptomatic hip or knee arthritis.
Cardiovascular hypotension.
Pregnancy.
BMI < 30.
Non arthritic conditions.
Arthritis affecting only joints distal to the tarsometatarsal joint.
Any inclusion criteria not met.
Unable to walk on a treadmill.

Chief Investigator:
Mr Heath Taylor
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Key Co-Investigator(s):
Mr Daniel Marsland
Mr John Grice
Mr James Creasey

Location(s):
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust