NCT05209802

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

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

January 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
Last Updated

February 7, 2025

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

January 13, 2022

Last Update Submit

February 4, 2025

Conditions

Rheumatic Diseases

Keywords

Rheumatic DiseasesAquatic exerciseHigh-intensity

Outcome Measures

Primary Outcomes (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.

    Change from baseline at 3 and 6 months

Secondary Outcomes (10)

  • Change in 30 STS

    Change from baseline at 3 and 6 months

  • Change in Patients Global Assessment score

    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).

    Change from baseline at 3 and 6 months

  • Change in Quality of Life

    Change from baseline at 3 and 6 months

  • Change in patients' level of physical activity

    Change from baseline at 3 and 6 months

  • +5 more secondary outcomes

Study Arms (2)

A: Exercise

EXPERIMENTAL

High intensity interval exercise training (4 x 4 minutes of intensity above 17 on the Borg Rating of Perceived Exertion)

Other: Group A: High intensity exercise training

B: Exercise

ACTIVE COMPARATOR

Moderate intensity exercise training

Other: Group B: moderate intensity exercise training

Interventions

Group A: High intensity exercise trainingOTHER

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

A: Exercise
Group B: moderate intensity exercise trainingOTHER

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

B: Exercise

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Metroplitan University

Oslo, 0130, Norway

Location

Related Publications (2)

  • 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.

    PMID: 41238358DERIVED

  • 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.

    PMID: 40132852DERIVED

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Heidi Bunæs-Næss, MSc

    Oslo Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 27, 2022

Study Start

February 1, 2022

Primary Completion

December 22, 2022

Study Completion

May 12, 2023

Last Updated

February 7, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)