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Not Yet RecruitingNCT07377214

Effect of Aquatic Therapy and Subsequent Training on Veterans With PTSD

AquaTherapy and Subsequent Training for 50 Veterans With PTSD - A Feasibility Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
AquaTerapi · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This project investigates the effect of Aquatic Therapy followed by group training for 50 veterans diagnosed with PTSD. Around 40% of Danish veterans experience insufficient benefit from current standard treatments, especially regarding sleep and quality of life. The study is a single-group, pre-post feasibility study, where participants receive 16 weeks of individual aquatic therapy (twice weekly) in a 34 °C pool, followed by 16 weeks of group-based aquatic exercise (once weekly). Participants are recruited through military psychiatric clinics and veteran organizations. The primary outcome is change in PTSD symptoms measured by the PCL-M questionnaire. Secondary outcomes include sleep quality (PSQI), quality of life (WHO-5), anxiety and depression (HSCL-25), and social participation. Data are collected before, after, and at one-year follow-up. The study also evaluates feasibility in terms of recruitment, adherence, acceptability, and follow-up rates. The aim is to achieve clinically relevant reductions in PTSD symptoms, improved sleep, and enhanced quality of life. The project is conducted in collaboration with military psychiatric services, and veteran organizations, and is managed by Gentofte Hospital. The intervention is considered safe and non-invasive, and all ethical and data protection regulations are followed. The project will provide rapid access to new treatment, generate knowledge for national implementation. Previous studies indicate marked and lasting improvements in sleep, symptoms, and quality of life, supporting reintegration into work and social life.

Detailed description

Post-traumatic stress disorder (PTSD) is prevalent among military veterans and is commonly associated with persistent hyperarousal, sleep disturbances, and reduced quality of life. Although trauma-focused psychotherapy and pharmacological treatment are considered first-line interventions, a substantial proportion of veterans continue to experience residual symptoms, particularly related to sleep, physiological stress regulation, and daily functioning. This highlights the need for complementary, non-pharmacological interventions that address both psychological and somatic aspects of PTSD. Aquatic therapy delivered in warm water represents a body-based intervention with potential relevance for trauma-exposed populations. The physical properties of warm water, including buoyancy, hydrostatic pressure, and thermal effects, may facilitate relaxation, reduce muscle tension, and support autonomic nervous system regulation. Trauma-informed aquatic therapy further emphasizes safety, predictability, and bodily awareness, which are considered central mechanisms in reducing hyperarousal and improving sleep and well-being in individuals with PTSD. Preliminary Danish and international studies suggest that aquatic therapy is safe and may lead to clinically meaningful improvements in PTSD-related symptoms, sleep quality, and quality of life among veterans with chronic PTSD. The present study evaluates a structured, two-phase aquatic intervention consisting of an initial individual therapy phase followed by group-based aquatic exercise. The individual phase is designed to establish a sense of safety, promote relaxation, and enhance body awareness through one-to-one sessions with a physiotherapist in a warm water environment. This phase aims to reduce physiological stress responses and prepare participants for more active and socially oriented exercise. The subsequent group-based phase focuses on gradual reintroduction of physical activity and social participation through supervised aquatic exercise, with the intention of consolidating treatment gains and supporting longer-term maintenance. The study is conducted as a single-group, pre-post feasibility study. The primary objective is to assess the feasibility of delivering the intervention to veterans with PTSD, including recruitment procedures, adherence to the intervention, acceptability of the treatment model, and the practicality of follow-up assessments. As a feasibility study, the trial is not powered to test efficacy, but to inform the design, procedures, and outcome selection for a future randomized controlled trial. Secondary objectives include exploring changes in PTSD-related symptoms, sleep quality, and quality of life to support planning of subsequent controlled studies. Data are collected at baseline, immediately after completion of the intervention, and at one-year follow-up using validated self-report instruments. In addition, qualitative feedback is collected to capture participant experiences, perceived benefits, and potential barriers to participation. These data will be used to refine the intervention protocol and study procedures prior to potential scaling or evaluation in a controlled trial. The intervention is non-invasive and delivered by experienced physiotherapists trained in aquatic therapy for trauma-exposed populations. All study procedures are conducted in accordance with applicable ethical guidelines and data protection regulations

Conditions

Interventions

TypeNameDescription
OTHERAquaTherapyThe intervention consists of a 32-week program for veterans diagnosed with PTSD, delivered in two consecutive phases. The first phase comprises 16 weeks of individual Aquatic Therapy where each participant receives one-on-one aquatic physiotherapy sessions with a trained physiotherapist in a warm water pool (34-36°C), twice weekly. These sessions focus on relaxation, gentle movement, and body awareness, aiming to reduce stress and establish a sense of safety and calm. Following the individual phase, participants transition to a 16-week group-based aquatic training program. This second phase involves weekly sessions in small groups (up to six participants per group) and emphasizes cardiovascular fitness, strength, mobility, and relaxation, all conducted in the same warm water environment. The group format is designed to reinforce physical gains, promote social engagement, and support the maintenance of improved activity levels.

Timeline

Start date
2026-01-01
Primary completion
2027-12-31
Completion
2027-12-31
First posted
2026-01-29
Last updated
2026-02-02

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT07377214. Inclusion in this directory is not an endorsement.