NCT07352696

Brief Summary

The goal of this randomised controlled trial is to evaluate the effects of a 12-week intervention comprising high-intensity interval aerobic training and strength training on cardiovascular function, metabolic health profile and inflammation in patients with Psoriatic arthritis. A secondary goal is to assess the intervention´s impact on physical fitness, pain, fatigue, and health-related quality of life, and to explore long-term maintenance of exercise following completion of the intervention. We hypothesize that 12 weeks of combined high-intensity interval aerobic training and strength training will improve cardiometabolic health, inflammation, and enhance physical fitness, fatigue, pain and quality of life in Psoriatic arthritis.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet 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

Study Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

December 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 22, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

December 15, 2025

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cardiopulmonary function

    Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity.

    Baseline and 3 month

  • Cardiopulmonary function

    Change in maximum oxygen uptake (VO2ml/min/kg). Higher value indicate better cardiorespiratory capacity)

    Baseline and 9 month

Secondary Outcomes (59)

  • Waist circumference

    Baseline and 3 months

  • Waist circumference

    Baseline and 9 months

  • Body mass index (BMI)

    Baseline and 3 months

  • Body mass index (BMI)

    Baseline and 9 months

  • Body composition

    Baseline and 3 months

  • +54 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Cardiorespiratory and strength training, 2-3 sessions per week for a total of 12 weeks.

Behavioral: Exercise program

Control group

NO INTERVENTION

Care as usual, plus individualized counseling for health-promoting physical activity

Interventions

The exercise program includes two supervised sessions per week combining high-intensity interval training and strength training, plus one additional non-supervised aerobic session. The target of the high intensity intervals is 90%-95% of heart rate maximum. The strength training of major muscle groups includes 2-3 sets of 8-10 repetitions.

Exercise group

Eligibility Criteria

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

You may qualify if:

  • Psoriatic arthritis disease according to the CASPAR (Classification Criteria for Psoriatic Arthritis) criteria
  • Age range 18-65 years

You may not qualify if:

  • Cardiovascular disease
  • Severe hypertension
  • Diabetes type I
  • Chronic obstructive pulmonary disease or other severe pulmonary diseases
  • Arthroplasty of large joints, lower extremities
  • Severe functional impairment precluding participation in high-intensity aerobic exercise
  • Inability to perform a cardiopulmonary exercise testing (CPET)
  • Pregnancy
  • BMI ≥35 kg/m²
  • Ongoing or planned initiation (within 3 months) of structured weight reduction therapy, pharmacological obesity treatment, or bariatric bypass surgery
  • Already participating in regular exercise at high intensity (BORG ≥15) for \>1 hour/ week during the past 6 months
  • Inability to understand and read Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University hospital

Gothenburg, Sweden

Location

Skaraborgs sjukvård, Skövde

Skövde, Sweden

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Annelie Bilberg, Assoc. Prof.

    Sahlgrenska University hospital, Gothenburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelie Bilberg, Assoc. Prof.

CONTACT

Eva Klingberg, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treatment versus care as usual
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 20, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

January 22, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in a publication are available from the principal investigator (P.I.) on reasonable request. Access will be determined based on reasonable request and in accordance with the ethical approval

Time Frame
The data will become available as following, starting 6 months after publication and end 5 years after publication.
Access Criteria
The requests will be reviewed by the P.I. and the steering committee. Study plans on meta-analyses generating new knowledge on exercise in persons with rheumatic diseases will be approved.

Locations