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

NCT01813578 | Completed

• 2 other identifiers: Norrbacka 20090000
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis; Exercise; Physical capacity; Aerobic capacity; Muscle function; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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.

Other Outcomes (4)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Exercise OTHER

Intensive aerobic and muscle endurance exercise

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• limited or diffuse SSc
• age 18-80 years
• diagnosis duration \> 1 year
• unchanged medication since 3 months
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska Univeristy Hospital, Solna

Stockholm, Stockholm County, 171 76, Sweden

Location

Related Publications (1)

• 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.

  PMID: 24507585 DERIVED

MeSH Terms

Conditions

Scleroderma, Systemic; Motor Activity; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Helene Alexanderson, PhD, RPT

  Karolinska University Hospital / Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD; RPT

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 19, 2013
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

SE (1)