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Effects of Intensive Aerobic and Muscle Endurance Exercise in Patients With Systemic Sclerosis - a Pilot Study

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ClinicalTrials.gov Identifier: NCT01813578
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : March 19, 2013
Sponsor:
Information provided by (Responsible Party):
Helene Alexanderson, Karolinska University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Systemic Sclerosis Other: Exercise Not Applicable

Detailed Description:

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.

As systemic sclerosis is a very rare condition a Single Subject Experimental Design (SSED) was used including a 6-week non-interventional A-phase where patients are assessed systematically followed by an 8-week interventional B-phase where patients exercise three days a week with continued systematic assessments. According to the 2-standard deviation (2 SD) band analysis, statistical analysis were performed for each patient individually. Accordingly, a statistically significant change was detected if two consecutive assessments in the B-phase exceeded the 2 standard deviations (SD) of the mean of the A-phase.

Patients were recruited from an ongoing study at the Karolinska University Hospital with the purpose to screen all patients with systemic sclerosis in Stockholm for cardiovascular disease. All patients meeting the inclusion criteria were invited to participate in this exercise study.

Assessments:

The six minute walking test was used to assess physical capacity. A submaximal treadmill test was used to estimate oxygen uptake in ml/kg x min. Muscle endurance was assessed by the Functional Index 2 registering the number of correct performed repetitions in 7 muscle groups. Pain, Raynaud's Phenomenon, fatigue and global disease impact on general well-being was assessed by the Visual Analogue scale (VAS), 0-100. Limitations in activities of daily living were assessed using the Health Assessment Questionnaire and the SF-36 was included to assess perceived health.

The Exercise program:

The program starts with a 10-minute warm-up session with biking at an intensity corresponding to perceived light exertion (10 on the Borg RPE, 6-20 scale). Thereafter, the load is increased to reach an intensity corresponding to perceived heavy exertion (15 on the Borg RPE scale) for an additional 15 minutes. During the last five minutes of the biking session, the loads are reduced to an intensity corresponding to light exertion. Heart rate was is recorded with a pulse watch (RS100 Polar) and peripheral saturation recorded with a heart rate oximeter (Wristox 3100 Nonin Medical). During the first weeks patients start on lower leads and increasing to the goal intensity. After the biking exercises, the participants perform repetitive dynamic muscle resistance training with the goal to achieve as many repetitions as possible in shoulder flexion and in hip flexion.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Intensive Aerobic and Muscle Endurance Exercise in Patients With Systemic Sclerosis - a Pilot Study
Study Start Date : October 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010


Arm Intervention/treatment
Experimental: Intervention
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.
Other: Exercise
Intensive aerobic and muscle endurance exercise




Primary Outcome Measures :
  1. Six minute walking test assessing change in physical capacity compared to baseline. [ Time Frame: At 0,2,4,6,8,10,12,14 weeks ]
    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.


Secondary Outcome Measures :
  1. Submaximal treadmill test. [ Time Frame: Assessed at 0,2,4,6,8,10,12, and 14 weeks ]
    The Minor treadmill test assessed estimated oxygen uptake in ml/kg x min. The test requires a total of eight minutes where the first four minutes are performed on a horizontal treadmill with the patient walking at a self-elected walking speed. During the following four minutes, the patient continues at the same walking speed on a 5 % incline. Work heart rate, saturation, central and peripheral exertion according to the Borg RPE 6-20 scale were recorded after completion of the test.

  2. Functional Index-2 [ Time Frame: Assessed at 0,2,4,6,8,10,12 and 14 weeks. ]
    Functional Index 2 assessed muscle endurance by recording the number of correct performed repetitions in seven muscle groups; Shoulder flexion, shoulder abduction, neck flexion, hip flexion, knee extension, dorsal- and plantar flexion of the ankle. Maximal number of repetitions varies between 0-60 or 0-120 repetitions.


Other Outcome Measures:
  1. Pain [ Time Frame: Assessed at 0, 6 and 14 weeks ]
    Pain was rated on a Visual Analogue scale, 0-100

  2. Raynaud's Phenomenon [ Time Frame: Assessed at 0,6 and 14 weeks ]
    Patients rated impact of Raynaud's Phenomenon on a VAS, 0-00

  3. Fatigue [ Time Frame: Assessed at 0,6 and 14 weeks ]
    Patients rated fatigue on VAS, 0-100.

  4. Disease impact on general well-being [ Time Frame: Assessed at 0,6, and 14 weeks. ]
    Patients rated impact on well-being on a VAS, 0-100.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • limited or diffuse SSc
  • age 18-80 years
  • diagnosis duration > 1 year
  • unchanged medication since 3 months
  • 50-100 % of normal vital capacity
  • exercising < once a week
  • speak and understand the Swedish language
  • average or below aerobic capacity according to the submaximal treadmill test (< 27 ml/kg x min for women and < 30 ml/kg x min for men)
  • < 20 % reduced muscle endurance according to the Functional Index-2

Exclusion Criteria:

  • Sendoxan treatment for alveolitis
  • Pulmonal hypertension (PAH)
  • heart condition contraindicating exercise
  • < 50 % of normal vital capacity
  • reduced kidney function
  • not being able to perform the exercise program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813578


Locations
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Sweden
Karolinska Univeristy Hospital, Solna
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Helene Alexanderson, PhD, RPT Karolinska University Hospital / Karolinska Institutet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helene Alexanderson, PhD; RPT, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01813578     History of Changes
Other Study ID Numbers: Norrbacka 2009
0000 ( Other Grant/Funding Number: Centre for care Science, KI, Norrbacka Eugeniastiftelsen )
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Keywords provided by Helene Alexanderson, Karolinska University Hospital:
Systemic sclerosis
Exercise
Physical capacity
Aerobic capacity
Muscle function
Fatigue

Additional relevant MeSH terms:
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Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases