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Completed

NCT Number: NCT01813578

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Univeristy Hospital, Solna

Stockholm, Stockholm County, 171 76, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Intensive aerobic and muscle endurance exercise

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2013
Registry last updated
Mar 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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