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.
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.
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.
- Conditions
- Rheumatic Diseases
- 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 group | Role | What they receive |
|---|---|---|
| A: Exercise | Experimental | High 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: Exercise | Active comparator | Moderate 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.
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)
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
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
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
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
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
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
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
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
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
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.
- First posted27 Jan 2022
- Study start1 Feb 2022
- Primary completion22 Dec 2022
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation
- Responsible party
- Sponsor
- Investigators
- Heidi Bunæs-Næss, MSc, Principal investigator, Oslo Metropolitan University
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 41238358Bunaes-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
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Aquatic Exercise for Adults with Rheumatic Diseases (AquaHigh)
- ClinicalTrials.gov ID
- NCT05209802
- Acronym / sponsor ID
- AquaHigh / 272749
- Conditions
- Rheumatic Diseases
- Keywords
- Rheumatic Diseases, Aquatic exercise, High-intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- The Dam Foundation
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 27 Jan 2022 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Exercise | Experimental | Other: Group A: High intensity exercise trainingHigh intensity interval exercise training (4 x 4 minutes of intensity above 17 on the Borg Rating of Perceived Exertion) |
| B: Exercise | Active comparator | Other: Group B: moderate intensity exercise trainingModerate intensity exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Group A: High intensity exercise trainingBoth group will receive aquatic exercise training twice a week for 12 weeks at different intensities | Other | A: Exercise |
| Group B: moderate intensity exercise trainingBoth group will receive aquatic exercise training twice a week for 12 weeks at different intensities | Other | B: Exercise |
Primary outcome
Change in peak oxygen consumption
Time frame: Change from baseline at 3 and 6 months
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.
10 secondary outcomes
Change in 30 STS
Time frame: Change from baseline at 3 and 6 months
Change in Patients Global Assessment score
Time frame: Change from baseline at 3 and 6 months
Change in the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) physical function form (PF-8a).
Time frame: Change from baseline at 3 and 6 months
Change in Quality of Life
Time frame: Change from baseline at 3 and 6 months
Change in patients' level of physical activity
Time frame: Change from baseline at 3 and 6 months
Change in reported pain
Time frame: Change from baseline at 3 and 6 months
Change in fatigue
Time frame: Change from baseline at 3 and 6 months
Demographic variables
Time frame: Baseline and change from baseline to 3 and 6 months for age, smoking, medications
Training diary
Time frame: From baseline to 3 months. From 3 to 6 months is optional
Self-reported physical activity (HUNT)
Time frame: From baseline to 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 41238358Bunaes-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.
- Derived from this study: PubMed 40132852Bunaes-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.
- Individual participant dataSharing planned: No
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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.
Heidi Bunæs-Næss, MSc principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
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.