Developing an exercise intervention to improve bone mineral density in traumatic amputees: protocol for a Delphi...

Lower limb amputation results in reduced bone mineral density (BMD) on the amputated side. Exercise interventions have proven effective in improving BMD. However, such interventions have not been attempted in an amputee population. Exercises designed for people with intact limbs may not be suitable for amputees, due to joint loss and the mechanical interface between the exercise equipment and the femoral neck being mediated through a socket. Therefore, prior to intervention implementation, it would be prudent to leverage biomechanical knowledge and clinical expertise, alongside scientific evidence in related fields, to assist in intervention development. The objective of this study is to elicit expert opinion and gain consensus to define specific exercise prescription parameters to minimise/recover BMD loss in amputees.

The Delphi technique will be used to obtain consensus among international experts; this will be conducted remotely as an e-Delphi process. 10-15 experts from ≥2 continents and ≥5 countries will be identified through published research or clinical expertise. Round 1 will consist of participants being asked to rate their level of agreement with statements related to exercise prescription to improve amputee BMD using a 5-point Likert Scale. Agreement will be deemed as ≥3 on the Likert Scale. Open feedback will be allowed in round 1 and any statement which less than 50% of the experts agree with will be excluded. Round 2 will repeat the remaining statements with the addition of any input from round 1 feedback. Round 3 will allow participants to reflect on their round 2 responses considering statistical representation of group opinion and whether they wish to alter any of their responses accordingly. Statements reaching agreement rates of 70% or above among the experts will be deemed to reach a consensus and will be implemented in a future exercise interventional trial.

Ethical approval was received from Imperial College Research Ethics Committee (reference: 6463766). Delphi participants will be asked to provide digital informed consent. The findings will be disseminated through peer-reviewed publications.