Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-01-27
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Land-based exercise
Traditional active exercise in an land-based setting (i.e., gym) has been shown to be effective in improving chronic pain management.
Land-based Exercise
Traditional land-based training will take place the Hydrathletics gym with similar exercises provided to the aquatic therapy group.
The aerobic exercise for the land-based therapy group will be 20 minutes of treadmill walking. The intensity will be determined by the participant at self-selected intensities that are not perceived to cause a lasting increase in pain for one hour after the exercise session.
The 20 minutes of strengthening exercise will focus on similar movement patterns to the aquatic therapy group to simulate common daily functional activities. Initial intensity of exercises will be determined in collaboration between the health professional and patient by testing the intensity of the exercise that allows the participant to perform 8 repetitions without experiencing a lasting increased in pain. Exercise intensity will be increased weekly by either increasing the number of repetitions or the resistance used for the exercise.
Aquatic exercise
Exercise completed in a therapy pool with warm water that is matched to the active comparator.
Aquatic exercise
Participants in the aquatic therapy group will receive aquatic therapy in a HydroWorx aquatic therapy pool at Hydrathletics.
In the aquatic therapy group the 20 minutes of aerobic exercise at each visit will involve walking on an underwater treadmill. The intensity of the walking will be determined by the participant at self-selected intensities that are not perceived to cause a lasting increase in pain for one hour after the exercise session.
The 20 minutes of strengthening exercise will focus on movement patterns that simulate common daily functional activities. Initial intensity of exercises will be determined in collaboration between the health professional and patient by testing the intensity of the exercise that allows the participant to perform 8 repetitions without experiencing a lasting increased in pain. Exercise intensity will be increased weekly by either increasing the number of repetitions or increasing resistance.
Interventions
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Aquatic exercise
Participants in the aquatic therapy group will receive aquatic therapy in a HydroWorx aquatic therapy pool at Hydrathletics.
In the aquatic therapy group the 20 minutes of aerobic exercise at each visit will involve walking on an underwater treadmill. The intensity of the walking will be determined by the participant at self-selected intensities that are not perceived to cause a lasting increase in pain for one hour after the exercise session.
The 20 minutes of strengthening exercise will focus on movement patterns that simulate common daily functional activities. Initial intensity of exercises will be determined in collaboration between the health professional and patient by testing the intensity of the exercise that allows the participant to perform 8 repetitions without experiencing a lasting increased in pain. Exercise intensity will be increased weekly by either increasing the number of repetitions or increasing resistance.
Land-based Exercise
Traditional land-based training will take place the Hydrathletics gym with similar exercises provided to the aquatic therapy group.
The aerobic exercise for the land-based therapy group will be 20 minutes of treadmill walking. The intensity will be determined by the participant at self-selected intensities that are not perceived to cause a lasting increase in pain for one hour after the exercise session.
The 20 minutes of strengthening exercise will focus on similar movement patterns to the aquatic therapy group to simulate common daily functional activities. Initial intensity of exercises will be determined in collaboration between the health professional and patient by testing the intensity of the exercise that allows the participant to perform 8 repetitions without experiencing a lasting increased in pain. Exercise intensity will be increased weekly by either increasing the number of repetitions or the resistance used for the exercise.
Eligibility Criteria
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Inclusion Criteria
* Canadian Armed Forces Veteran
* Living with lower-extremity musculoskeletal chronic pain (\>12 weeks)
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
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Queen's University
OTHER
Dr. Nicholas Held
OTHER
Responsible Party
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Dr. Nicholas Held
Principal Investigator
Principal Investigators
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Nicholas Held, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Hydrathletics Inc.
Kingston, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Nicholas Held, PhD
Role: primary
Other Identifiers
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6036919
Identifier Type: -
Identifier Source: org_study_id