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临床试验/NCT05869617
NCT05869617招募中不适用

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

Dr. Nicholas Held1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Retention rate

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome questionnaires are completed prior to participants being allocated to treatment groups. Unable to blind participants as it is obvious that they will be exercise on land or in water.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Over the age of 18 years
  • •Canadian Armed Forces Veteran
  • •Living with lower-extremity musculoskeletal chronic pain (>12 weeks)

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Land-based Exercise (Other)

Aquatic exercise

Experimental

Exercise completed in a therapy pool with warm water that is matched to the active comparator.

干预措施: Aquatic exercise (Other)

结局指标

主要结局

Retention rate

时间窗: Through study completion, an average of 1 year

percentage of participants who complete the scheduled follow-up assessments at each time point.

Treatment adherence

时间窗: 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.

Recruitment rate

时间窗: Through study completion, an average of 1 year

participants recruited per week.

Outcome measure completion rate

时间窗: Through study completion, an average of 1 year

percentage of items completed across all outcome measures at all time points.

Treatment fidelity

时间窗: 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.

次要结局

  • 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).)

研究者

发起方
Dr. Nicholas Held
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Nicholas Held

Principal Investigator

Queen's University

研究点 (1)

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