Clinical trial NCT05992649: The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject
Official title: The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: vandfys
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
First posted: 2023-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group study
Primary purpose: TREATMENT

Brief summary: Aquatic physiotherapy in warm water pool (AP) is thought to be a helpful treatment for veterans suffering from post-traumatic stress disorder (PTSD). A 40-week program can provide an opportunity to achieve positive results.

Potentiel effects of AP for veterans with PTSD:

Relaxation and stress reduction, anxiety and mood regulation, body awareness and grounding, strength and flexibility and social interactions and camaraderie.

Detailed description: It is estimated that 5% of all veterans who have been deployed have PTSD. In Denmark the total number of deployments are about 27.000 from 1992 - 2012.

The purpose of the project is to investigate the effect of aquatic physiotherapy treatment and physical training in 34-35 degree centigrade warm water in a 40-week program consisting of:

1. st 8 weeks: 30 minutes treatment once a week.
2. nd 8 weeks: 30 minutes treatment once a week +

60 minutes of combined training and relaxation once a week.

3rd 8 weeks: 60 minutes of combined training and relaxation once a week + an activity of own choice once a week.

4th period 16 weeks: 30 minutes treatment once a week + 60 minutes of combined training and relaxation once a week.

Hypothesis:

Veterans with PTSD will experience a reduction in levels of PTSD symptoms.

Methodical approach:

Design: pilot project with an intervention group of 12 receiving treatment and physical training.

Recruitment:

The participants are recruited from Copenhagen Veteran Home, Høvelte Barracks Veteran Home and Military Psychiatric Outpatient Clinic, Rigshospitalet.

cf. inclusion and exclusion criteria.

No of participants to be recruited: 12

Primary effect measures:

Change of PTSD level from baseline using validated questionnaire PCL-M

Secondary effect measures:

1. Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep Quality Index (PSQI).
2. Change of self-perceived levels of depression and anxiety by questionnaire (Hopkins symptoms checklist)
3. Change in self-perceived quality of wellbeing measured by questionnaire (WHO-5) Measurements to be taken before and after 24-weeks intervention

Explorative measures:

Change in functionality/ability with everyday life measured by questionnaire (The questionnaire method for assessing functionality/ability

Ethical considerations:

Participation in warm water treatment is considered without side effects or risks.

Using exercise in warm water is part of general physiotherapeutic practice. The treatment is handled by experienced physiotherapists. The project complies with the Helsinki Declaration.

Eligibility criteria: Inclusion Criteria:

* Veteran and have been diagnosed with PTSD.
* Enjoy being in water.
* Have a desire for treatment and training in warm water.
* Will fill out questionnaires and respond to SMS messages related to treatment.
* Speak, read, and understand Danish fluently.
* Will set goals for future participation in local community activities.
* Have practical means to participate (Wednesday and Friday afternoons).
* Can attend treatment or receive assistance with transportation to treatment at Tuborgvej, 2400 Copenhagen NV.
* Any substance abuse should be under control (self-medication, alcohol, and drugs)

Exclusion Criteria:

* fear of water
* physical condition that hinders movement in water
* Fear of getting water in the ears

Primary outcomes:
measure: Level of symptoms of PTSD
timeFrame: 40-weeks
Secondary outcomes:
measure: Quality of sleep
timeFrame: 40-weeks
measure: Levels of symptoms of depression and anxiety
timeFrame: 40-weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Lions kollegiets varmtvandsbassin
Study officials:
affiliation: Herlev & Gentofte Hospital
name: Carsten Bogh Juhl, Professor
role: STUDY_CHAIR
References: