Effect of Aquatic Physiotherapy for People With Stress

NCT05223855 | Completed DMC

• 1 other identifier: 0221
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Brief summary: Effect of aquatic physiotherapy for people with stress; a randomized controlled trial (RCT) The purpose of the project is to investigate the effect of aquatic physiotherapy treatment in 34-36 degrees warm water. The study is a randomized controlled trial, and participants are recruited from GPs in Lyngby-Taarbæk as well as Gentofte Kommune. The participants are randomized using numbered, opaque and sealed envelopes. Method: The intervention Aquatic physiotherapy 1: 1 treatment in 34-36 degrees centigrade warm water. 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 Group: The intervention group is treated twice a week. Duration of each treatment is 30 minutes. Period of treatment is 8 weeks. Control Group: The control group receives usual care through their GP for 8 weeks. Then they are offered participation in a de-stress class in 34-36 degrees centigrade warm water, twice a week. Duration of each treatment is 30 minutes. Period of treatment is 8 weeks. EFFECT MEASURES:

1. 1.Primary effect measures:
2. 2.Secondary effect measures:

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• Level of stress

  Cohens 10-item Perceived Stress Scale. A self-reported questionnaire of 10 questions that measures to which extent the respondent experiences that life is unpredictable, uncontrollable and overwhelming. Each question yields a score ranging from 0 to 4, with 4 indicating the highest level. The scores are summed to yield a total score ranging from 0 to 40 Minimum value is 0 Maximum value is 40 The aim of the evaluation is therefore to assess whether the respondent experiences a reduction in the degree of stress.

  8 weeks

Secondary Outcomes (1)

• Sleep disorder

  8 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The intervention group receives intervention for 8 weeks

Other: Physiotherapeutic hydrotherapy treatment

control group

NO INTERVENTION

The control group receives usual care for 8 weeks and is then offered participation in a de-stress class for 8 weeks.

Interventions

Physiotherapeutic hydrotherapy treatment OTHER

Physiotherapeutic hydrotherapy treatment The intervention consists of physiotherapeutic one-on-one treatment in a 34-36 degrees centigrade hot water, where the participants are placed supine in the water supported by the physiotherapist as well as buoyant aqua noodles. The physiotherapist supports and moves the participants in the water and adapts to the participant's reaction. The combination of heat, water, movement and touch affects the musculoskeletal and neuromuscular systems and thus has a depth-relaxing effect (Schoedinger, 2010).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has been reported sick by GP within the last four weeks, and is now on sick leave with stress.
• Is 18 years or older.
• Is on sick leave from work or school
• Speaks, reads and understands Danish fluently.
• Has had symptoms of stress during the last month
• Is willing to fill out questionnaires before, during and after treatment/treatment period.
• Has the possibility to participate
• Would like treatment in hot water
• Has given informed consent

You may not qualify if:

• Previously been on sick leave with stress.
• Long-term / unresolved cases with authorities or former partners / spouses.
• Is taking sleep medication.
• Known with bipolar disorder.
• Fear of water.
• Fear of getting ears under water
• Physical state that prevents movement in water

Sponsors & Collaborators

• Herlev and Gentofte Hospital: collaborator
• vandfys: lead

Study Sites (1)

Lions Kollegiets varmtvandsbassin

Copenhagen, Copenhagen, 2400, Denmark

Location

Study Officials

• Carsten Bogh Juul, phD

  Herlev & Gentofte Hospitalers Forskningsenhed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant is presented a numbered, opaque, sealed envelope. The outcomes assessor will be presented with data masked from group participations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: Intervention group receives intervention twice a week for 8 weeks. Control group receives usual care through GP for 8 weeks, and are then offered participation in de-stress class twice a week for 8 weeks.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: February 4, 2022
• Study Start: January 27, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 5, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)