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The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 24-week Pilotproject

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
physical therapy
Sponsored by
vandfys
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lions kollegiets varmtvandsbassinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aquatic physiotherapy treatment in warm water

Arm Description

The participant is placed supine in the water, supported by the physiotherapist as well as aqua noodles. The physiotherapist supports and moves the participant in the water and adapts to the participant's reaction.

Outcomes

Primary Outcome Measures

Level of symptoms of PTSD
Measured by self reported questionnaire PTSD Checklist for military (PCL-M). The self-report rating scale is 0-4 for each symptom (0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items. A score between 17-29 suggests little to no severity. A score between 28-29 suggests some PTSD symptoms.

Secondary Outcome Measures

Quality of sleep
Measured by self reported questionnaire Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Levels of symptoms of depression and anxiety
Measured by self reported questionnaire Hopkins symptoms checklist. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items, while the depression score is the average of the 15 depression items, and the anxiety score is the average of the 10 anxiety items. Higher scores indicate worse level of depression and/or anxiety

Full Information

First Posted
August 7, 2023
Last Updated
September 4, 2023
Sponsor
vandfys
Collaborators
Herlev and Gentofte Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05992649
Brief Title
The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 24-week Pilotproject
Official Title
The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 24-week Pilotproject
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2023 (Anticipated)
Primary Completion Date
February 23, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
vandfys
Collaborators
Herlev and Gentofte Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 24-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 24-week program consisting of: st 8 weeks: 30 minutes treatment once a week. 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. 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: Change of sleep disorders from baseline using validated questionnaire Pittsburgh Sleep Quality Index (PSQI). Change of self-perceived levels of depression and anxiety by questionnaire (Hopkins symptoms checklist) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group study
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aquatic physiotherapy treatment in warm water
Arm Type
Experimental
Arm Description
The participant is placed supine in the water, supported by the physiotherapist as well as aqua noodles. The physiotherapist supports and moves the participant in the water and adapts to the participant's reaction.
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
Aquatic physiotherapy in warm water
Primary Outcome Measure Information:
Title
Level of symptoms of PTSD
Description
Measured by self reported questionnaire PTSD Checklist for military (PCL-M). The self-report rating scale is 0-4 for each symptom (0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items. A score between 17-29 suggests little to no severity. A score between 28-29 suggests some PTSD symptoms.
Time Frame
24-weeks
Secondary Outcome Measure Information:
Title
Quality of sleep
Description
Measured by self reported questionnaire Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time Frame
24-weeks
Title
Levels of symptoms of depression and anxiety
Description
Measured by self reported questionnaire Hopkins symptoms checklist. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items, while the depression score is the average of the 15 depression items, and the anxiety score is the average of the 10 anxiety items. Higher scores indicate worse level of depression and/or anxiety
Time Frame
24-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lone Nedergaard, bsc
Phone
+45 24288777
Email
lone@vandfys.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Nielsen, Master
Email
christina@vandfys.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carsten Bogh Juhl, Professor
Organizational Affiliation
Herlev & Gentofte Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Lions kollegiets varmtvandsbassin
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lone Nedergaard, bsc
Phone
+45 24288777
Email
lone@vandfys.dk
First Name & Middle Initial & Last Name & Degree
Christina Nielsen, master
Email
christina@vandfys.dk

12. IPD Sharing Statement

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