NCT05992649

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 23, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

August 7, 2023

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    40-weeks

Secondary Outcomes (2)

  • Quality of sleep

    40-weeks

  • Levels of symptoms of depression and anxiety

    40-weeks

Study Arms (1)

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.

Other: physical therapy

Interventions

Aquatic physiotherapy in warm water

Aquatic physiotherapy treatment in warm water

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lions kollegiets varmtvandsbassin

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Carsten Bogh Juhl, Professor

    Herlev & Gentofte Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator physiotherapist

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

September 23, 2023

Primary Completion

July 4, 2024

Study Completion

July 4, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations