Clinical trial NCT05869617: Aquatic Exercise for Veterans in Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Exercise
military Veterans
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Queen's University
First posted: 2023-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Recruitment rate
timeFrame: Through study completion, an average of 1 year
measure: Retention rate
timeFrame: Through study completion, an average of 1 year
measure: Outcome measure completion rate
timeFrame: Through study completion, an average of 1 year
measure: Treatment fidelity
timeFrame: Through study completion, an average of 1 year
measure: Treatment adherence
timeFrame: Through the length of the intervention, completed at 8 weeks
Secondary outcomes:
measure: Physical function
timeFrame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
measure: Pain severity
timeFrame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
measure: Pain interference
timeFrame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
measure: Health-related quality of life
timeFrame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
measure: Sleep quality
timeFrame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hydrathletics Inc.
state: Ontario
Study officials:
affiliation: Queen's University
name: Nicholas Held, PhD
role: PRINCIPAL_INVESTIGATOR
References: