Post Traumatic Stress DisorderNCT05992649
The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject
A study testing physical therapy in people with Post Traumatic Stress Disorder, run by vandfys at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Sep 2023to 4 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- fear of water
- physical condition that hinders movement in water
- Fear of getting water in the ears
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
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:
- 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- physical therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
Aquatic physiotherapy in warm water
| Study group | Role | What they receive |
|---|---|---|
| Aquatic physiotherapy treatment in warm water | Experimental | 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. Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40-weeks
Secondary outcomes (2)
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.
Measured: 40-weeks
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
Measured: 40-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start23 Sep 2023
- Primary completion4 Jul 2024 (estimated)
- Study completion4 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- vandfys
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Lone Nedergaard, vandfys
- Investigators
- Carsten Bogh Juhl, Professor, Study chair, Herlev & Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992649
- Sponsor's protocol ID
- V24
- Status last verified
- Mar 2024
- First submitted
- 7 Aug 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject
- ClinicalTrials.gov ID
- NCT05992649
- Acronym / sponsor ID
- V24
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- vandfysUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 4 Jul 2024 (estimated)
- Study completion
- 4 Jul 2024 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group study
| Arm | Type | Receives |
|---|---|---|
| Aquatic physiotherapy treatment in warm water | Experimental | Other: physical therapyThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- fear of water
- physical condition that hinders movement in water
- Fear of getting water in the ears
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapyAquatic physiotherapy in warm water | Other | Aquatic physiotherapy treatment in warm water |
Primary outcome
Level of symptoms of PTSD
Time frame: 40-weeks
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.
2 secondary outcomes
Quality of sleep
Time frame: 40-weeks
Levels of symptoms of depression and anxiety
Time frame: 40-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Bogh Juhl, Professor study chair
Herlev & Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy in people with Post Traumatic Stress Disorder, run by vandfys at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of symptoms of PTSD (time frame: 40-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.