Determining the Effectiveness of Aquatic Exercise in Comparison to Land-based Exercise for Canadian Military Veterans Experiencing Chronic Lower Extremity Musculoskeletal Pain: A Feasibility Study for a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Dr. Nicholas Held
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Retention rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This trial is to show the feasibility of administering a randomized clinical trial that determines the effectiveness of aquatic exercise compared to land-based exercise of military Veterans who have chronic pain.
Detailed Description
As of March 31, 2020, Veterans Affairs Canada estimated the total Veteran population in Canada to be 629,300. It has been reported that 41 percent of Veterans experience constant pain or discomfort, which is close to double the 22 percent reported by the Canadian population. Pain is a complex phenomenon that involves biological, psychological, and social determinants and impacts. Evidence suggests Veterans have unique pain management needs and evaluation of interventions is urgently needed to address the complex needs of Canadian Military Veterans living with chronic pain. Aquatic therapy is a possible treatment option that may improve outcomes in military Veterans with chronic pain. Aquatic therapy has previously been shown to decrease pain, improve function or disability, increase quality of life, and improve health-related fitness measures . Most of the research showing effectiveness of aquatic therapy for musculoskeletal pain conditions has involved comparing aquatic therapy to a control group; however, a control group does not accurately reflect current best practice for people with lower extremity musculoskeletal pain. Clinical practice guidelines suggest physical activity and exercise interventions as first-line treatment for people with lower extremity musculoskeletal pain, but do not provide direction on what type of exercise is most effective for people with lower extremity pain. Building on existing research by comparing aquatic therapy to a land-based exercise comparison will provide a more robust evaluation of the effectiveness to inform clinical practice guidelines. Additionally, given their unique health needs, there is a need for evidence specific to the military Veteran population. 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 reducing the risk of bias (e.g., most studies did not describe allocation concealment) and conducting a fully powered trial. Additionally, important differences between groups in satisfaction of participants and a gap in terms of understanding the experiences are emerging. Further research on the experiences and perspectives of participants is needed. Most importantly, there have been no studies on the effectiveness or experiences of aquatic therapy among Canadian Military Veterans living with pain. Given the unique needs of this population, evidence specific to this group is needed in order to inform service delivery. Prior to conducting a fully powered trial, there is a need for a pilot study to determine the feasibility of carrying out the interventions and trial procedures. Primarily, the ability to recruit Canadian Military Veterans who live with chronic pain into the study and to determine if participants have the opportunity to book and attend two sessions per week for eight weeks. Objectives: 1. Determine feasibility of trial methods, including patient recruitment rate, assessment procedures, and attrition. 2. Determine the feasibility of implementing the aquatic exercise and land-based exercise interventions as designed. 3. Explore the perspectives of patients and health professionals related to the acceptability of the interventions and trial methods, barriers, facilitators and strategies for implementation; and perceived impact on clinic processes and outcomes.
Investigators
Dr. Nicholas Held
Principal Investigator
Queen's University
Eligibility Criteria
Inclusion Criteria
- •Over the age of 18 years
- •Canadian Armed Forces Veteran
- •Living with lower-extremity musculoskeletal chronic pain (\>12 weeks)
Exclusion Criteria
- •Pain of \< 12 weeks duration
- •cancer-related pain and pain suspected to be associated with a degenerative neurological condition
- •surgery or fracture in the last 6 months
- •medical contraindications to exercise (e.g., recent myocardial infarction, acute heart failure)
Outcomes
Primary Outcomes
Retention rate
Time Frame: Through study completion, an average of 1 year
percentage of participants who complete the scheduled follow-up assessments at each time point.
Recruitment rate
Time Frame: Through study completion, an average of 1 year
participants recruited per week.
Outcome measure completion rate
Time Frame: Through study completion, an average of 1 year
percentage of items completed across all outcome measures at all time points.
Treatment fidelity
Time Frame: Through study completion, an average of 1 year
using a treatment fidelity checklist, as describe below, we will consider how often a practitioner adheres to the recommended exercises and if the participants complete all exercises in a session.
Treatment adherence
Time Frame: Through the length of the intervention, completed at 8 weeks
measured based on attendance through the treatment fidelity checklist. In an 8-week period, participants will be asked to attend 16 sessions which will be confirmed by the practitioner handing in the fidelity checklist to the study team after each session.
Secondary Outcomes
- Pain severity(Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).)
- Health-related quality of life(Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).)
- Sleep quality(Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).)
- Physical function(Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).)
- Pain interference(Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).)