A Digital Exercise Intervention in Patients With Spondyloarthritis (SPARK)

The SPARK Trial: a Digital Exercise Intervention in Patients With Spondyloarthritis

This protocol describes a 6-month randomised, controlled exercise trial in patients with axial spondyloarthritis (axSpA) with re-randomization after 3-months. The primary outcome of the trial (disease activity) will be evaluated at 3-months. The exercise programme on trial comprises high intensity interval training (HIIT), muscular strength exercise and aerobic physical activity sessions of specified duration, frequency, and intensity. It also includes brief knowledge videos to empower the patient. The intervention is remotely delivered by the SPARK application with personalised follow-up including monitoring to ensure exercise progression and adherence to exercise intensity. The SPARK application is built on a platform delivered by ABEL Technologies (trademark) and is customised for patients with axSpA.

Study Overview

• Status: Not yet recruiting
• Conditions: Exercise; Spondyloarthritis
• Intervention / Treatment: Behavioral: Exercise with supervision; Behavioral: Exercise without supervision

Detailed Description

Main objectives: To assess if a digital personally tailored exercise program with remote follow-up can reduce disease activity measured by ankylosing spondylitis disease activity score (ASDAS) in patients with recently diagnosed axial spondyloarthritis (axSpA).

Main inclusion criteria Adults (> 18 years) with clinical diagnosis from a rheumatologist of axSpA within the last 2 years of inclusion also fulfilling the ankylosing spondylitis disease activity score (ASAS) classification criteria, who are biologic disease modifying anti-rheumatic drugs (bDMARD) naïve, and have an active disease (ASDAS ≥ 1.3)

Main exclusion criteria:

Active iridocyclitis, c-reactive protein (CRP) > 30, contraindication to high intensity interval training

Primary outcome Proportion of participants in ASDAS inactive (ASDAS < 1.3) at 3 months

Number of participants: 260 (with an anticipated drop-out rate of 15%)

Study design: A two-arm multi-centre, clinical trial, randomization 1:1 to either digital exercise intervention with remote follow-up or usual care.

Intervention: Exercise delivered through an application and with personalised follow-up by a coach through remote sessions (the participant and SPARK-coach are not at the same physical location) weekly. The exercise is progressively tailored to the fitness level of each participant. The program consists of 5 session per week on 3 different days including: two sessions with HIIT, 2 sessions with strength exercise, and one session with an aerobic exercise at moderate intensity. Goal for HIIT is 10 minutes two times per week at 85-95% of maximal heart rate (20 minutes in total). The exercise will be performed at a location of the participants' choice and data will be logged by a sports watch.

Efficacy assessments: ASDAS disease activity measure (4 patient reported questions and measure of CRP), Bath ankylosing spondylitis disease activity index (BASDAI).

Physical measure: cardiorespiratory fitness, in a subset of participants direct cardiopulmonary testing, muscular strength tests.

Psychological measures: Warwick and Edinburgh mental wellbeing scale (WEMWBS), EuroQol (EQ5D).

Medication: use of bDMARDs, use of NSAID

Safety assessments General physical examination and vital signs, laboratory tests as a part of usual clinical care, record of adverse events and serious adverse events, magnetic resonance imaging (MRI).

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sella A Provan, Professor; Phone Number: +4791582581; Email: SellaProvan@gmail.com
• Study Contact Backup: Name: Birgitte Nellemann, PhD; Phone Number: +4747957020; Email: birgittenellemann@gmail.com

Study Locations

• Norway
  • Oslo, Norway
    • Diakonhjemmet hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• axSpA diagnosis within the last two years by a rheumatologist according to the ASAS criteria of 2009
• active disease (ASDAS > 1.3)

Exclusion Criteria:

• Active uveitis.
• CRP > 30.
• Former or current use of bDMARDs.
• Pregnancy or planned pregnancy within 6 months from inclusion.
• Absolute and relative contradictions to high intensity exercise according to the American College of Sports Medicine (ACSM)
• Other serious disease such as cancer.
• Patients incapable to follow the protocol or the control set-up with remote monitoring.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise with personal supervision 0-3 months; Exercise	Behavioral: Exercise with supervision; Remote exercise will be administered with digital supervision. The Exercise group will receive a personalised program with individual adaptations aiming to perform 3 exercise sessions per week including HIIT, strength exercise and moderate intensive aerobic exercise. Participants will consult their rheumatologist parallel to the SPARK trial.
No Intervention: Control 0-3 months; Usual care
Experimental: Exercise with personal supervision 3-6 months; Exercise	Behavioral: Exercise with supervision; Remote exercise will be administered with digital supervision. The Exercise group will receive a personalised program with individual adaptations aiming to perform 3 exercise sessions per week including HIIT, strength exercise and moderate intensive aerobic exercise. Participants will consult their rheumatologist parallel to the SPARK trial.
Active Comparator: Exercise without personal supervision 3-6 months; Exercise	Behavioral: Exercise without supervision; Remote exercise will be administered without digital supervision. Participants will receive a standard exercise program fulfilling the exercise protocol requirements, the exercise program will progress. But there will be no direct contact between the participant and the coach. Participants will consult their rheumatologist parallel to the SPARK trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity 3 months	Number of participants in ASDAS inactive (ASDAS < 1.3) at 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biologic disease modifying anti-rheumatic drugs 3 months	Number of participants on biologic disease modifying anti-rheumatic drugs (bDMARD) at 3 months	3 months
Disease activity 6 months	Number of participants in ankylosing spondylitis disease activity score (ASDAS) inactive (ASDAS < 1.3) at 6 months	6 months
Proportion of participants using non-steroidal anti-inflammatory drugs	Usage of non-steroidal anti-inflammatory drugs (NSAIDs)	3 and 6 months
Bath ankylosing spondylitis metrology index	Physical function measured by Bath ankylosing spondylitis metrology index (BASMI). Range 0-10 where 0= no functional impairment 10=very significant impairment	3 and 6 months
Bath ankylosing spondylitis function index	Physical function measured by Bath ankylosing spondylitis function index (BASFI). Scale range 0-10, where 0= no functional impairment 10=very significant impairment	3 and 6 months
Ankylosing spondylitis Performance Index	Physical function measured by Ankylosing spondylitis Performance Index (ASPI). Continuous variable in units of minutes. The functional level is inversely proportional to the number of minutes.	3 and 6 months
Physical fitness	Indirect exercise test on a tread-mill until exhaustion. Measured in oxygen uptake ml/min/kg.	3 and 6 months
Physiological effects of exercise on lipids	Effect of exercise on lipids	3 and 6 months
Physiological effects of exercise on inflammation measured by CRP	Effect of exercise on CRP	3 and 6 months
Physiological effects of exercise on blood pressure	Effect of exercise on blood pressure	3 and 6 months
Physiological effects of exercise on weight	Effect of exercise on weight in kg	3 and 6 months
Physiological effects of exercise on muscle mass	Effect of exercise on body composition measured as percentage muscle mass	3 and 6 months
Physiological effects of exercise on adipose tissue	Effect of exercise on body composition measured as percentage adipose tissue	3 and 6 months
Safety measures of exercise Spine	Safety measures: MRI spine in a subset of participants at baseline and after 3 months of exercise. Level of inflammation scored by Canadian Spondyloarthritis Research Consortium score (SPARCC). High score represents more inflammation. The minimum score 0, max score 108	3 and 6 months
Safety measures of exercise Sacroiliac joints	Safety measures: MRI sacroiliac joints in a subset of participants at baseline and after 3 months of exercise. Level of inflammation scored by Canadian Spondyloarthritis Research Consortium (SPARCC). High score represents more inflammation. The minimum score 0, max score 72	3 and 6 months
Effects of exercise on mental wellbeing	Quality of life Warwick Edinburgh Mental Wellbeing Scale WEMWBS). Range 14-70. A higher score indicates greater mental well-being	3 and 6 months
Effects of exercise on quality of life	Quality of life EQ5D. Range -0.59 to 1, where 1 is the best possible health state	3 and 6 months
Work presenteeism	Health economy measures: work presenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)	6 months
Work absenteeism	Health economy measures: work absenteeism expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)	6 months
Work impairment	Health economy measures: work overall impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)	6 months
Functional impairment	Health economy measures: functional impairment expressed in percentage (%) measured by Work Productivity and Activity Impairment Questionnaire (WPAI)	6 months
Contact with the Healthcare services	Health economy measures: Contact with the health care services. Self reported as number of visits to general practitioner, specialist healthcare and/or physiotherapist during past 3 months	6 months
Sleep quality	Questionnaire on sleep quality: Pittsburgh Sleep Questionnaire. Global score ranges from 0 to 21 and higher scores indicate poorer sleep quality.	3 and 6 months
Physical activity level	Physical activity level measured for one week at baseline, 3 months and 6 months by a movement sensor. (Actigraph). The score will be presented as Metabolic Equivalents. A high score represents more movement	Baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Estimated): June 17, 2024

Study Record Updates

• Last Update Posted (Estimated): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: High intensity interval training; Digital; Remote
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: DS00735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No