Determining the effectiveness of aquatic exercise in comparison to land-based exercise for Canadian military Veterans living with chronic lower extremity musculoskeletal pain A feasibility study protocol for a randomized clinical trial

Background Canadian Armed Forces (CAF) Veterans report living with chronic pain at nearly double the rate of comparable Canadians. Currently, little to no research focusses on CAF Veterans engaging in aquatic exercise as a physical activity-based rehabilitation program. To date, there have been eight randomized clinical trials comparing aquatic exercise to land-based exercise on function or disability for people with lower extremity musculoskeletal pain. While meta-analyses reveal no difference between these two groups in pain, function, and quality of life, this body of research is limited by small sample sizes and risks of bias, making it difficult to draw conclusions and apply the evidence of effectiveness in practice. There are opportunities to improve rigor by conducting a fully powered trial, however, there is need for a pilot study prior to a fully powered trial to determine the feasibility of carrying out the interventions and trial procedures. Methods A parallel group pilot randomized controlled trial (RCT) to determine the feasibility of conducting a future fully powered RCT to determine the effectiveness of aquatic exercise versus land-based exercise. Participants will be randomized in a 1:1 ratio to aquatic therapy or land therapy groups. In addition, semi-scripted participant interviews will be conducted in order to understand the acceptability of the interventions and trial methods, as well as barriers, facilitators and strategies for implementation through an interpretive description approach. Discussion While there is some existing evidence on the effectiveness of aquatic exercise for individuals living with pain, there is a need to conduct a more rigorous randomized controlled trial, particularly on CAF Veterans. A decision will be taken as to whether the study is recommended to progress to a full randomized controlled trial which includes the perspective of the organization and healthcare providers that are implementing the study protocol as well as the perspective of the participants. The purpose of a future RCT is to assess the effectiveness of aquatic exercise compared to traditional land-based exercise in order improve pain, physical function, and health-related quality of life for CAF Veterans living with pain. Trial registration: This protocol has been registered in ClinicalTrials.gov ID: NCT005869617 – May 16, 2023. https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000D733&selectaction=Edit&uid=U0006MPH&ts=2&cx=t4hlaw