Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869617
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-04-21
Brief Title:
Aquatic Exercise for Veterans in Pain
Sponsor:
Dr Nicholas Held
Organization:
Queens University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 629300 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None