NCT04368494

Brief Summary

Regular exercise, such as brisk walking, has been shown to lower levels of indicators of inflammation in the blood in people with long term conditions. This includes people with heart disease, kidney disease and diabetes. Axial Spondyloarthritis (axSpA) is an inflammatory condition with prescribed medication focusing on reducing inflammation. However, the effect of exercise on indicators of inflammation in axSpA is unknown. The research study intends to investigate whether a 12-week period of regular exercise can have favourable effects on inflammatory markers in the blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

2 active sites

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

April 17, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

April 17, 2020

Last Update Submit

March 20, 2023

Conditions

Axial SpondyloarthritisInflammatory DiseaseArthritis

Keywords

Exercise

Outcome Measures

Primary Outcomes (4)

  • Changes in interleukin-6 blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    Fasting blood concentration.

    0, 4, 8, 12, 20 weeks.

  • Changes in tumor necrosis factor-alpha blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    Fasting blood concentration.

    0, 4, 8, 12, 20 weeks.

  • Changes in interleukin-10 blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    Fasting blood concentration.

    0, 4, 8, 12, 20 weeks.

  • Changes in c-reactive protein blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    Fasting blood concentration.

    0, 4, 8, 12, 20 weeks.

Secondary Outcomes (21)

  • Changes in creatine kinase blood concentrations before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    0, 4, 8, 12, 20 weeks.

  • Changes in inflammatory immune cell phenotypes before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    0, 4, 8, 12, 20 weeks.

  • Changes in ankylosing spondylitis disease activity before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    0, 4, 8, 12, 20 weeks.

  • Changes in the symptom burden of ankylosing spondylitis before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    0, 4, 8, 12, 20 weeks.

  • Changes in spinal pain before (week 0 - baseline), during (weeks 4, 8, and 12), and after (week 20) the 12-week home based exercise intervention.

    0, 4, 8, 12, 20 weeks.

  • +16 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Continue with normal activity.

Exercise

EXPERIMENTAL

12-weeks of home based exercise involving 30 minutes of brisk walking on 5 days per week.

Behavioral: 12-week home based exercise

Interventions

12-week home based exerciseBEHAVIORAL

Patients allocated to the exercise arm will be prescribed a home-based walking exercise programme consisting of 30 minutes of walking on 5 days per week at an RPE in the range of 12-14 (somewhat hard). Each patient's heart rate range will be established during the baseline exercise test by recording the heart rate response at the required RPE target range. This will be provided to each patient to use in conjunction with the activity monitor they will be given to wear on their non-dominant wrist. The monitor reports heart rate and records daily steps, distance and activity duration.

Exercise

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Axial Spondyloarthritis by a consultant rheumatologist.
  • Without other significant cardiovascular comorbidities.
  • Receiving stable dose NSAID treatment.
  • Able to commit to the time demands of the study.

You may not qualify if:

  • Unable to undertake exercise due to physical or psychological barriers.
  • Presence of hip or peripheral joint disease.
  • Contraindication to exercise training (American College of Sports Medicine guidelines).
  • Excessively active (score of high on International Physical Activity Questionnaire).
  • Unable to communicate sufficiently in English.
  • Female participants who are pregnant, lactating, or planning pregnancy during the course of the study.
  • Inability to give informed consent or comply with the testing and training protocol for any reason.
  • Presence of chronic anaemia.
  • Co-morbidity that the research team determine to be a contraindication to involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals of Leicester NHS trust

Leicester, LE15WW, United Kingdom

Location

Loughborough University, National Centre for Sport and Exercise Medicine

Loughborough, LE113TU, United Kingdom

Location

Related Publications (1)

  • Roberts MJ, Hamrouni M, Linsley V, Moorthy A, Bishop NC. Exercise as an anti-inflammatory Therapy in Axial Spondyloarthritis Therapeutic Intervention (EXTASI) study: a randomized controlled trial. Rheumatol Adv Pract. 2024 May 11;8(2):rkae062. doi: 10.1093/rap/rkae062. eCollection 2024.

    PMID: 38854418DERIVED

MeSH Terms

Conditions

Axial SpondyloarthritisArthritisMotor Activity

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesBehavior

Study Officials

  • Arumugam Moorthy, Dr

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Random allocation into either a control group or an exercise group (12-weeks of home based exercise).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 29, 2020

Study Start

October 1, 2021

Primary Completion

December 10, 2022

Study Completion

December 10, 2022

Last Updated

March 21, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)