Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Centre for care Science, KI, Norrbacka Eugeniastiftelsen
interventional
4
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)Study Completion
April 2010
Actual (reported)The hypothesis is that intensive aerobic and endurance muscle training is safe and beneficial in patients with systemic sclerosis and concurrent interstitial lung disease. The purpose of the study is to examine the effect of an eight week intensive aerobic exercise and muscle endurance training program for patients with systemic sclerosis and 50-100 % of forced vital capacity. A single subject experimental design with repeated systematic measures during a six week A-phase (baseline period) and an eight week B-phase (intervention period) was used. Physical capacity (six minute walk test), aerobic capacity (submaximal treadmill test) and muscle endurance in shoulder and hip flexion (Functional Index 2) are assessed every other week throughout the 14 week study. Activity limitation (Health Assessment Questionnaire), quality of life (Short Form 36), Raynaud, Fatigue and Global Health during the recent week (Visual Analogue Scales) are assessed at weeks 0, 6, 14. The exercise program includes aerobic exercise corresponding to 15 on the Borg RPE scale (strenuous) and muscular endurance training three times/week.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 2010
Actual (reported)April 2010
Actual (reported)March 13, 2013
Actual (reported)March 19, 2013
Actual (reported)Six minute walking test assessing change in physical capacity compared to baseline.
The six minute walking test assesses physical capacity by recording the walking distance achieved during 6 minutes. The participant is instructed to walk in a self-selected speed, but try to walk as fas a distance as possible. Heart rate, saturation and self-rated central and peripheral exertion is assessed at rest and after 2,4, and 6 minutes.
At 0,2,4,6,8,10,12,14 weeks
Submaximal treadmill test.
Assessed at 0,2,4,6,8,10,12, and 14 weeks
Functional Index-2
Assessed at 0,2,4,6,8,10,12 and 14 weeks.
Pain
Assessed at 0, 6 and 14 weeks
Raynaud's Phenomenon
Assessed at 0,6 and 14 weeks
Fatigue
Assessed at 0,6 and 14 weeks
An SSED study is an open-label design where the individual is his or her own control. All patients included received the same exercise intervention.
Intensive aerobic and muscle endurance exercise
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Karolinska Univeristy Hospital, Solna
Stockholm, Stockholm County, 171 76, Sweden
Alexanderson H, Bergegard J, Bjornadal L, Nordin A. Intensive aerobic and muscle endurance exercise in patients with systemic sclerosis: a pilot study. BMC Res Notes. 2014 Feb 7;7:86. doi: 10.1186/1756-0500-7-86.
Helene Alexanderson, PhD, RPT
Karolinska University Hospital / Karolinska Institutet
4 participants (actual enrollment reported by the registry).
First Submitted
March 13, 2013
First Posted
March 19, 2013
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Vasculopathy, Inflammation and Systemic Sclerosis
Contact the study team to confirm eligibility.
Primary Completion
April 2010
Actual (reported)Study Completion
April 2010
Actual (reported)Last Updated
March 19, 2013
Record last verified: 2013-03
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Source: ClinicalTrials.gov.
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