Chronic PainNCT05869617
Aquatic Exercise for Veterans in Pain
A study testing Aquatic exercise and Land-based Exercise in people with Chronic Pain, run by Dr. Nicholas Held at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Aquatic exercise and Land-based Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 18 years
- Canadian Armed Forces Veteran
- Living with lower-extremity musculoskeletal chronic pain (>12 weeks)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hydrathletics Inc.
Kingston, Ontario, K7P 2W5
Nicholas Held, PhD, 613-384-3111, njh1@queensu.ca
Nicholas Held, PhD
About this study
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
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.
Read the 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:
- Determine feasibility of trial methods, including patient recruitment rate, assessment procedures, and attrition.
- Determine the feasibility of implementing the aquatic exercise and land-based exercise interventions as designed.
- 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
- Chronic Pain
- Being tested
- Aquatic exercise, Land-based Exercise
- Keywords
- Exercise, military Veterans
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic exerciseOther
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 ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Land-based exercise | Active comparator | Traditional active exercise in an land-based setting (i.e., gym) has been shown to be effective in improving chronic pain management. Receives: Other: Land-based Exercise |
| Aquatic exercise | Experimental | Exercise completed in a therapy pool with warm water that is matched to the active comparator. Receives: Other: Aquatic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
participants recruited per week.
Measured: Through study completion, an average of 1 year
Retention rate
percentage of participants who complete the scheduled follow-up assessments at each time point.
Measured: Through study completion, an average of 1 year
Outcome measure completion rate
percentage of items completed across all outcome measures at all time points.
Measured: Through study completion, an average of 1 year
Treatment fidelity
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.
Measured: Through study completion, an average of 1 year
Treatment adherence
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.
Measured: Through the length of the intervention, completed at 8 weeks
Secondary outcomes (5)
Physical function
Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS has previously been shown to be reliable, and construct validity has been supported by comparison with the SF-36. A score is provided for each of the 20 activities from 0 (extreme difficulty or unable to perform activity) to 4 (no difficulty). LEFS is scored by summating all points for all activities to equate a minimum score of zero and a maximum score of 80. The lower the score, the greater the associated disability. A minimal detectable change of 9 points has been reported for LEFS.
Measured: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Pain severity
Brief Pain Inventory (BPI) is a questionnaire developed to assess the severity of pain and pain interference. The severity index will be used to determine pain levels at the three time points of interest. The BPI has been validated previously for the assessment of pain severity, including musculoskeletal pain. Mean pain severity is scored by self-reporting the average pain on a 10-point scale from "no pain" to "pain as bad as you can imagine".
Measured: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Pain interference
the Brief Pain Inventory (BPI) interference index will be used to assess pain interference. The BPI -Pain interference index measures how much pain interferes with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations to others, and sleep. Each of the seven questions is scored on a scale from 0-10 with higher scores representing more interference. Pain interference is scored as the mean of the seven interference items. Scores in these seven areas can be categorized as affective interference (enjoyment with life, mood, and relations to others) and activity interference (general activity, walking, work, and sleep) subscales.
Measured: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Health-related quality of life
The EuroQol EQ-5D-5L is a validated, self-reporting tool used to assess quality of life based on five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Under each dimension, participants check a box that best indicates the level of problems they have within that dimension. Each box is coded from 1 (no problem) to 5 (severe problems). Additionally, participants complete a 100-point visual analog scale on their overall health for the day.
Measured: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality and disturbance retrospectively over a 1-month period using self-reports. PSQI scores are moderately to highly correlated with measures of sleep quality and sleep problems, and poorly correlated with unrelated constructs. Individuals with sleep problems, poor sleep quality, and sleep restlessness score significantly higher PSQI scores in comparison to individuals without such problems. The PSQI includes 19 self-rated questions that are combined to form seven "component" scores, each with a range of 0-3 points. In all cases, a score of "0" indicates no difficulty and a score of "3" indicates severe difficulty. These seven component scores are then added to yield on "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
Measured: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start27 Jan 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Nicholas Held
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Sponsor-investigator, Dr. Nicholas Held, Queen's University
- Investigators
- Nicholas Held, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869617
- Sponsor's protocol ID
- 6036919
- Status last verified
- Dec 2023
- First submitted
- 21 Apr 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual IPD among other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05869617
- Acronym / sponsor ID
- 6036919
- Conditions
- Chronic Pain
- Keywords
- Exercise, military Veterans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dr. Nicholas HeldUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine feasibility of trial methods, including patient recruitment rate, assessment procedures, and attrition.
- Determine the feasibility of implementing the aquatic exercise and land-based exercise interventions as designed.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Land-based exercise | Active comparator | Other: Land-based ExerciseTraditional active exercise in an land-based setting (i.e., gym) has been shown to be effective in improving chronic pain management. |
| Aquatic exercise | Experimental | Other: Aquatic exerciseExercise completed in a therapy pool with warm water that is matched to the active comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over the age of 18 years
- Canadian Armed Forces Veteran
- Living with lower-extremity musculoskeletal chronic pain (>12 weeks)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic exerciseParticipants 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. | Other | Aquatic exercise |
| Land-based ExerciseTraditional 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. | Other | Land-based exercise |
Primary outcome
Recruitment rate
Time frame: Through study completion, an average of 1 year
participants recruited per week.
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.
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.
5 secondary outcomes
Physical function
Time frame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Pain severity
Time frame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Pain interference
Time frame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Health-related quality of life
Time frame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Sleep quality
Time frame: Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No. There is no plan to share individual IPD among other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Held, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic exercise and Land-based Exercise in people with Chronic Pain, run by Dr. Nicholas Held at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas Held, PhD (604-362-0061, njh1@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.