High-intensity Interval Exercise in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— RA-HIIT  

Official title:

Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05768165
• Other study ID #: Vastra Gotaland record 275642
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: March 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria

• Disease duration >1 year

• Age (range 20-60 years)

• Stable medication on anti- rheumatic drugs for >3 months

• Low-to-moderate disease activity (<5.1) according to the Disease activity score 28 (DAS28)

Exclusion Criteria:

• Cerebrovascular diseases

• Diabetes

• Severe hypertension

• Chronic obstructive pulmonary disease or other severe pulmonary diseases

• Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise

• Arthroplasty of large joints

• Inability to manage Cardiopulmonary Exercise Testing (CPET)

• Pregnancy

• Already participating in regular aerobic or strength exercise at a high intensity level (>1 hours/ week) during the last 6 months

• Inability to speak or read Swedish.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• High intensity exercise
Twelve weeks of supervised high intensity aerobic and resistance exercise including two sessions/week, one additional session of the patient´s own choice, non-supervised. The target of the high intensity intervals (HIIT) is 90%-95% of maximum heart rate alternated with recovery phases at 70% of maximal heart rate. The resistance exercise session of large muscle groups: 8-10 repetitions, 2-3 sets. Exercise guidance follows principles of self-efficacy and person-centeredness.

Locations

Country	Name	City	State
Sweden	Sahlgrenska university hospital	Göteborg
Sweden	Uddevalla Hospital	Uddevalla

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary function	Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)	0 -12 weeks
Secondary	Vascular function	Aortic pulse wave velocity (PWV) (m/sec.) (Higher PWV value indicate worse vascular function)	0-12 weeks
Secondary	Level of disease activity	Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)	0-12 weeks
Secondary	Level of disease activity	Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)	0-6 months
Secondary	Level of disease activity	Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)	0-12 months
Secondary	Homeostatic model assessment of insulin resistance (HOMA IR)	Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report HOMA IR	0-12 weeks
Secondary	Glycosylation level of hemoglobin (HbA1c)	Glycosylation level of hemoglobin (mmol/mol)	0-12 weeks
Secondary	Level of blood lipids	Levels of triglycerides (mmol/L), Level of high-density lipoprotein (HDL) (mmol/L), low-density lipoprotein (LDL) ( mmol/L), Total cholesterol (mmol/L )	0-12 weeks
Secondary	Erythrocyte Sedimentation Rate (ESR)	Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)	0-12 weeks
Secondary	Erythrocyte Sedimentation Rate (ESR)	Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)	0-6 months
Secondary	Erythrocyte Sedimentation Rate (ESR)	Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)	0-12 months
Secondary	C-Reactive Protein (CRP)	Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)	0-12 weeks
Secondary	C-Reactive Protein (CRP)	Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)	0-6 months
Secondary	C-Reactive Protein (CRP)	Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)	0-12 months
Secondary	Cytokine levels	Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL)	0-12 weeks
Secondary	Muscle function of lower extremities	The one minute sit-to-stand test (Higher numbers of complete rises indicate better muscle function in lower extremities)	0-12 weeks
Secondary	Hand-grip force	Hand-grip force is assessed with a dynamometer ( Higher value indicate better grip strength)	0-12 weeks
Secondary	Self-reported physical activity	Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)	0-12 weeks
Secondary	Self-reported physical activity	Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)	0-6 months
Secondary	Self-reported physical activity	Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)	0-12 months
Secondary	Objective assessment of physical activity	Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)	0-12 weeks
Secondary	Objective assessment of physical activity	Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)	0-6 months
Secondary	Objective assessment of physical activity	Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)	0-12 months
Secondary	Pain intensity	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)	0-12 weeks
Secondary	Pain intensity	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)	0-6 months
Secondary	Pain intensity	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)	0-12 months
Secondary	Global health	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)	0-12 weeks
Secondary	Global health	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)	0-6 months
Secondary	Global health	Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)	0-12 months
Secondary	Fatigue	The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue	0-12 weeks
Secondary	Fatigue	The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue	0-6 months
Secondary	Fatigue	The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue	0-12 months
Secondary	Sleep	Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).	0-12 weeks
Secondary	Sleep	Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).	0-6 months
Secondary	Sleep	Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).	0-12 months
Secondary	Activity limitations	Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)	0-12 weeks
Secondary	Activity limitations	Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)	0-6 months
Secondary	Activity limitations	Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)	0-12 months
Secondary	Attitude to exercise	Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.	0-12 weeks
Secondary	Attitude to exercise	Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.	0-6 moths
Secondary	Attitude to exercise	Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.	0-12 months
Secondary	Body compositions	Weight and height will be combined to report Body mass index BMI kg/m2 (A higher score indicate higher relative weight)	0-12 weeks
Secondary	Waist circumference	Measured with a tape measure midway between the lower rib and iliac crest. (A waist measurement of 80 centimeters or more for women and 94 centimeters or more for men indicate increased risk for diseases related to overweight)	0-12 weeks