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Investigating the effectiveness and feasibility of exercise on microvascular reactivity and quality of life in systemic sclerosis patients: study protocol for a feasibility study.

Trials
January 1, 1970
Alexandros Mitropoulos et al. (5 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Extracted Claims (12)
InterventionDirectionEndpointPopulationDosageImpactClaim #
aerobic exercise and resistance training, separately or combined
increase
micro- and macrovascular function
conditions that present vasculopathy
significant
have been demonstrated to lead to significant vasculo-physiological improvements
#1
high-intensity interval training (HIIT) combined with circuit resistance training
neutral
microvascular function in the digital area
SSc patients
-
assess the effects
#2
a 12-week supervised exercise programme
neutral
recruitment and retention rate, intervention acceptability and adherence to the exercise programme
patients with SSc in receipt of medical treatment
-
will be assessed
#3
a 12-week supervised exercise programme
neutral
digital area cutaneous microvascular function (laser Doppler fluximetry combined with iontophoresis)
patients with SSc in receipt of medical treatment
-
will be assessed
#4
a 12-week supervised exercise programme
neutral
physical fitness
patients with SSc in receipt of medical treatment
-
will be assessed
#5
a 12-week supervised exercise programme
neutral
functional ability
patients with SSc in receipt of medical treatment
-
will be assessed
#6
a 12-week supervised exercise programme
neutral
upper back transcutaneous oxygen tension
patients with SSc in receipt of medical treatment
-
will be assessed
#7
a 12-week supervised exercise programme
neutral
body composition
patients with SSc in receipt of medical treatment
-
will be assessed
#8
a 12-week supervised exercise programme
neutral
quality of life (EQ-5D-5L)
patients with SSc in receipt of medical treatment
-
will be assessed
#9
a combined exercise programme
neutral
feasibility
SSc patients
-
will be used to identify the feasibility
#10
a combined exercise programme
neutral
acceptability of the intervention and the study design
SSc patients
-
will be used to identify the acceptability
#11
exercise
neutral
microvasculature
-
-
will be used to determine the effects
#12
Abstract

BACKGROUND: Raynaud's phenomenon is one of the first clinical manifestations observed in systemic sclerosis (SSc). This microvasculature disorder affects mostly the digits in over 95% of SSc patients, significantly affecting their health-related quality of life (HRQoL) and incurring higher hospital admissions and other healthcare costs. Exercise is known to improve both micro- and macrovascular function - aerobic exercise and resistance training, separately or combined, have been demonstrated to lead to significant vasculo-physiological improvements in conditions that present vasculopathy. However, the effects of a combined exercise programme on microcirculation in SSc patients has yet to be investigated. Therefore, the purpose of this study is to assess the effects of high-intensity interval training (HIIT) combined with circuit resistance training on the microvascular function in the digital area of SSc patients. METHODS: This will be a randomised controlled, feasibility trial with two arms, wherein 30 patients with SSc in receipt of medical treatment will be randomly assigned to usual care (medical treatment) or to a 12-week supervised exercise programme. Patients in the exercise group will undertake two, 45-min sessions each week consisting of 30 min HIIT (30 s 100% peak power output/30 s passive recovery) on the arm crank ergometer and 15 min of upper body circuit resistance training. Patients will be assessed before as well as at 3 and 6 months following randomisation. Primary outcomes of the study will be recruitment and retention rate, intervention acceptability and adherence to the exercise programme. Secondary outcomes include the digital area cutaneous microvascular function (laser Doppler fluximetry combined with iontophoresis), physical fitness, functional ability, upper back transcutaneous oxygen tension, body composition and quality of life (EQ-5D-5L). Selected interviews with a subsample of patients will be undertaken to explore their experiences of having Raynaud's phenomenon and the acceptability of the exercise intervention and study procedures. DISCUSSION: Data from this study will be used to identify the feasibility of a combined exercise programme to be implemented in SSc patients, the acceptability of the intervention and the study design, and to determine the effects of exercise on the microvasculature. Overall, this study will provide sufficient data to inform and support a full multicentre clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov (NCT number): NCT03058887 , February 23, 2017.

Medical Subject Headings (MeSH)
AdolescentAdultAgedAged, 80 and overEnglandFeasibility StudiesFemaleHigh-Intensity Interval TrainingHumansMaleMicrocirculationMiddle AgedQuality of LifeRegional Blood FlowResistance TrainingScleroderma, SystemicSkinTime FactorsTreatment OutcomeYoung Adult
Study Links
Citation Metrics
Total Citations5
Citations/Year0.7
Relative Citation Ratio0.42
NIH Percentile22.6%
Research Impact Scores
APT Score0.25