ROCI
Research type
Research Study
Full title
Recovery in Open and Closed Tibial Shaft Fractures Innovative (ROCI) Physical Rehabilitation: A Feasibility Study Of Standardised Physical Rehabilitation In Previous Open and Closed Tibial Shaft Fracture Patients.
IRAS ID
318142
Contact name
Ian Pallister
Contact email
Sponsor organisation
Cardiff and Vale University Health Board
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Physical recovery after broken bones is the key to returning to normal activities, employment and independence. Even after a fracture of the tibia (broken shin bone) has been treated with surgery with a nail inserted into the middle of the bone to fix it, disability persists for over a year after this. This feasibility study will see whether two innovative approaches used together are tolerable and could be helpful. We will study blood flow restriction training (BFRT) and the use of a specialised exercise bike (Wattbike) in people recovering after a fracture tibia treated with a nail. By carefully restricting the blood flow to the affected leg using a band similar to a blood pressure cuff, the volunteers in the study can exercise very gently on a Wattbike. Experience in other areas of medicine and sports injuries has shown that BFRT is safe and builds muscle strength and endurance well. The Wattbike records the work done by each leg separately so this can be analysed. While exercising, the participant can see this represented on the Wattbike’s screen. This may help with motivation and performance. Participants who join the study will undergo a baseline assessment to see how well they are walking and to introduce them to BFRT and the Wattbike. Six weeks later, they will start a 6-week long programme of weekly BFRT sessions, plus questionnaires to record their health related quality of life, well-being and perceptions of their recovery. If participants find BFRT too uncomfortable to tolerate, they could remain in the study using the Wattbike alone.
By learning about the tolerability of BFRT, and its potential benefit along with the Wattbike, we hope to design a large-scale study. The ultimate goal is to develop an exercise programme suitable for people recovering from many other similar injuries.REC name
London - Fulham Research Ethics Committee
REC reference
22/PR/1338
Date of REC Opinion
22 Nov 2022
REC opinion
Further Information Favourable Opinion