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Rheumatic DiseasesAquaHighNCT05209802

High-intensity Aquatic Exercise for Adults with Rheumatic Diseases

A study testing Group A: High intensity exercise training and Group B: moderate intensity exercise training in people with Rheumatic Diseases, run by Oslo Metropolitan University at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare aquatic high intensity interval training with moderate intensity exercise training on exercise capacity in a population with rheumatic diseases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatic Diseases
What is being tested?
Group A: High intensity exercise training and Group B: moderate intensity exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteNorway
Study dates
1 Feb 2022to 12 May 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who
  • are 18 years or older,
  • have a diagnosis of any kind of RDs,
  • can walk with or without a walking aid and
  • understand Norwegian.

Who cannot join

  • medical contraindications to high intensity exercise,
  • life expectancy below 1 year and
  • currently participating or have participated in aquatic high intensity exercise programs or trials during the last 3 months.

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Oslo Metroplitan University

    Oslo, 0130

Other trials in Norway

About this study

Official title: High-intensity Aquatic Exercise for Adults with Rheumatic Diseases (AquaHigh)

The purpose of this study is to compare aquatic high intensity interval training with moderate intensity exercise training on exercise capacity in a population with rheumatic diseases.

Read the detailed description

Exercise is important to manage rheumatic diseases (RDs). In 2007, the American College of Sports Medicine (ACSM) launched a global initiative to advocate the use of exercise not only to prevent illness but to serve as a key element in the management and treatment of multiple chronic diseases. Their "Exercise is Medicine" initiative promotes exercise as a highly potent free medicine with few side effects. Despite catchphrases such as "best drug ever," few adhere to the global recommendations for weekly physical activities. Exercise is one of the therapeutic strategies that helps minimise deleterious effects on the musculoskeletal system generated by aging while preserving independence, promoting weight control, and maintaining or improving quality of life, functional capacity, and emotional well-being. However, exercises performed on the ground can aggravate joint pain and increase the risk of falls among those with RDs. Aquatic exercises are a popular adjunct treatment modality for patients with inflammatory RDs. Aquatic exercises are highly preferred by people with RDs, who are more likely to report feeling better than those treated with similar exercises on land. A preference for a water-based rehabilitation or environment may enable greater exercise compliance.

A systematic review and meta-analysis from 2011 concluded that the effects of aquatic exercise for adults with arthritis appears comparable to land-based exercise. When people are unable to exercise on land or find it difficult, aquatic programs provide an enabling alternative strategy.

Aquatic exercise programmes have been criticised for being non-progressive or low-intensive. One possible advantage of the aquatic environment is that the people with chronic diseases may be able to train at higher intensities than on land.

The effectiveness of aquatic exercise needs further comprehensive investigation, particularly related to the link between load, types of exercise, and degree of changes in physical functioning and physical fitness.

Method:

  • Design: The study will be a randomized clinical trial. Patients will be recruited from different municipalities in Norway with possibilities of pool training in temperate water (between 30-34°C to be optimal).
  • Intervention group: The intervention group will receive aquatic high intensity interval exercise training twice a week for 12 weeks.
  • Control group: The control group will receive aquatic moderate intensity exercise training twice a week for 12 weeks.
  • Sample Size Estimation: Sample size is calculated on the basis of the primary outcome variable, where a between-group difference in VO2peak of 15% or 3.5 mL∙kg-1∙min-1 is considered to be of clinical relevance. Both groups are receiving an exercise intervention, therefore we estimate a smaller between group difference to be 2.0 mL∙kg-1∙min-1. Using a reported standard deviation of change in VO2peak of 3 and 80% power to detect this difference, approximately 35 participants are required in each group. To allow for a possible 20% drop-out rate, we plan to randomise 84 patients in total (i.e. 42 per group).
  • Statistical analyzes: Descriptive data are reported for variables of interest and will be analysed following the intention-to-treat principle. Prospective differences in primary and secondary outcomes and baseline characteristics between the intervention group and the control group will be assessed by t-tests for continuous and normal distributed variables and non-parametric tests for categorical variables. Multiple linear regression modelling is used to control for confounding differences between study groups.

The study will provide evidence-based knowledge for performing high-Intensity water workout in municipalities and investigates the factors that determine successful effects on physical fitness, disease activity and pain and tests the programme's utility for municipal health care services.

Being tested
Group A: High intensity exercise training, Group B: moderate intensity exercise training
Keywords
Rheumatic Diseases, Aquatic exercise, High-intensity
Medical subject headings
Rheumatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A: High intensity exercise trainingOther

    Both group will receive aquatic exercise training twice a week for 12 weeks at different intensities

  • Group B: moderate intensity exercise trainingOther

    Both group will receive aquatic exercise training twice a week for 12 weeks at different intensities

Study groups in NCT05209802
Study groupRoleWhat they receive
A: ExerciseExperimentalHigh intensity interval exercise training (4 x 4 minutes of intensity above 17 on the Borg Rating of Perceived Exertion)
Receives: Other: Group A: High intensity exercise training
B: ExerciseActive comparatorModerate intensity exercise training
Receives: Other: Group B: moderate intensity exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in peak oxygen consumption

    Physical capacity will be assessed with a maximal walking treadmill test for estimation of peak oxygen consumption. A modified Balke protocol on a treadmill will be used.

    Measured: Change from baseline at 3 and 6 months

Secondary outcomes (10)
  1. Change in 30 STS

    The 30 sec sit-to-stand test (30STS) will be used is a measure of lower extremity strength

    Measured: Change from baseline at 3 and 6 months

  2. Change in Patients Global Assessment score

    Change in Patients Global Assessment score (PGA) is a self-reported measure in which the patient's overall disease activity is measured. The phrasing of PGA is not standardized, but the PGA of the American College of Rheumatology (ACR) and EULAR is based on the question "In all the ways in which your RDs affect you, how would you rate the way you felt over the past week?" PGA is reported on a 100-mm Visual Analogue Scale (VAS). Higher scores represent a high level of disease activity. PGA is reliable for the assessment of both joint and skin disease and a PGA score < 20 is defined as low disease activity.

    Measured: Change from baseline at 3 and 6 months

  3. Change in the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) physical function form (PF-8a).

    The 8-item Patient-Reported Outcomes Measurement Information System, (PROMIS) physical function form (PF-8a) is a brief patient-reported measure of physical function, Scale 5 (best) to 1 (worst)

    Measured: Change from baseline at 3 and 6 months

  4. Change in Quality of Life

    Euro Quality of life questionnaire (EQ5D-5L), Scale 1 (best) to 5 (worst) and Scale 0 (worst) to 100 (best)

    Measured: Change from baseline at 3 and 6 months

  5. Change in patients' level of physical activity

    The University of California, Los Angeles (UCLA) Activity Scale measures the patients' level of physical activity on a 10-point scale based on 10 descriptive activity levels ranging from wholly inactive and dependent to regular participation in impact sports. Scale 1 (worst) to 10 (best)

    Measured: Change from baseline at 3 and 6 months

  6. Change in reported pain

    The Numeric Rating Scale (NRS) for pain will be measured at rest and in activity on a 0-10 NRS. The patients mark a number from 0 (no pain) to 10 (worst pain)

    Measured: Change from baseline at 3 and 6 months

  7. Change in fatigue

    The Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ) score assesses NRS for fatigue severity, effect, and coping during the past 7 days. All three dimensions are rated from 0-10, and the total score is obtained by dividing the sum of individual scores by 3

    Measured: Change from baseline at 3 and 6 months

  8. Demographic variables

    We will record the following variables: age, living alone (yes/no), BMI, educational level, smoking (yes/no), medications, taking analgesics (yes/no), and comorbidities.

    Measured: Baseline and change from baseline to 3 and 6 months for age, smoking, medications

  9. Training diary

    Exercise frequency Participants are asked to record group-based exercise sessions and other individual exercise sessions in a training diary.

    Exercise intensity Participants are asked to record group-based exercise sessions in a training diary. Exercise intensity is recorded by use of a Borg RPE scale.

    Session deviation Participants are asked to record group-based exercise session in a training diary. Participants are asked to recording both early session terminations and absences from scheduled training sessions.

    Exercise-related adverse events Participants are asked to record group-based exercise session in a training diary. Participants are asked to record exercise-related adverse events.

    Measured: From baseline to 3 months. From 3 to 6 months is optional

  10. Self-reported physical activity (HUNT)

    Average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.

    Measured: From baseline to 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start1 Feb 2022
  3. Primary completion22 Dec 2022
  4. Study completion12 May 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05209802
Sponsor's protocol ID
272749
Acronym
AquaHigh
Status last verified
Jul 2024
First submitted
13 Jan 2022
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bunaes-Naess H, Nilsson BB, Kvael LAH, Heywood SE, Gerritsen RB, Heiberg KE. Effects of aquatic high-intensity interval training on patient-reported outcome measures and quality-adjusted life-years in adults with rheumatic and musculoskeletal diseases: a secondary analysis of the AquaHigh randomised controlled trial. BMJ Open. 2025 Nov 13;15(11):e102841. doi: 10.1136/bmjopen-2025-102841.

    PubMed 41238358
  • Bunaes-Naess H, Heywood SE, Kvael LAH, Heiberg KE, Nilsson BB. Effects of aquatic high-intensity interval training on aerobic capacity in adults with rheumatic and musculoskeletal diseases: the AquaHigh randomised controlled trial. BMJ Open. 2025 Mar 24;15(3):e090612. doi: 10.1136/bmjopen-2024-090612.

    PubMed 40132852

Questions about this trial

What is this clinical trial studying?

A study testing Group A: High intensity exercise training and Group B: moderate intensity exercise training in people with Rheumatic Diseases, run by Oslo Metropolitan University at 1 site in Norway.

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 5 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: finished, as of the sponsor's last update on 7 Feb 2025. 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 Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in peak oxygen consumption (time frame: Change from baseline at 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05209802, which also lists 2 linked publications.

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 7 Feb 2025.

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