Aquatic Exercise for Veterans in Pain

NCT05869617 | Unknown

• 1 other identifier: 6036919
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Exercise; military Veterans

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  participants recruited per week.

  Through study completion, an average of 1 year

• Retention rate

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

  Through study completion, an average of 1 year

• Outcome measure completion rate

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

  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.

  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.

  Through the length of the intervention, completed at 8 weeks

Secondary Outcomes (5)

• Physical function

  Pre-intervention (0 weeks), post-intervention (8 weeks) and follow-up (20 weeks).

• Pain severity

  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).

• 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).

Study Arms (2)

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.

Other: Land-based Exercise

Aquatic exercise

EXPERIMENTAL

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

Other: Aquatic exercise

Interventions

Aquatic exercise OTHER

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.

Aquatic exercise

Land-based Exercise OTHER

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.

Land-based exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Nicholas Held: lead
• Queen's University: collaborator

Study Sites (1)

Hydrathletics Inc.

Kingston, Ontario, K7P 2W5, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Nicholas Held, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas Held, PhD

CONTACT

604-362-0061; njh1@queensu.ca

Jordan Miller, PhD

CONTACT

905-872-9938; jordan.miller@queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 22, 2023
• Study Start: January 27, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)