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

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring Systemic sclerosis, Exercise, Physical capacity, Aerobic capacity, Muscle function, Fatigue

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Univeristy Hospital, Solna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Submaximal treadmill test.
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.
Functional Index-2
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.

Full Information

First Posted
March 13, 2013
Last Updated
March 14, 2013
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01813578
Brief Title
Effects of Intensive Aerobic and Muscle Endurance Exercise in Patients With Systemic Sclerosis - a Pilot Study
Official Title
Effects of Intensive Aerobic and Muscle Endurance Exercise in Patients With Systemic Sclerosis - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
Systemic sclerosis, Exercise, Physical capacity, Aerobic capacity, Muscle function, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Intensive aerobic and muscle endurance exercise
Primary Outcome Measure Information:
Title
Six minute walking test assessing change in physical capacity compared to baseline.
Description
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.
Time Frame
At 0,2,4,6,8,10,12,14 weeks
Secondary Outcome Measure Information:
Title
Submaximal treadmill test.
Description
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.
Time Frame
Assessed at 0,2,4,6,8,10,12, and 14 weeks
Title
Functional Index-2
Description
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.
Time Frame
Assessed at 0,2,4,6,8,10,12 and 14 weeks.
Other Pre-specified Outcome Measures:
Title
Pain
Description
Pain was rated on a Visual Analogue scale, 0-100
Time Frame
Assessed at 0, 6 and 14 weeks
Title
Raynaud's Phenomenon
Description
Patients rated impact of Raynaud's Phenomenon on a VAS, 0-00
Time Frame
Assessed at 0,6 and 14 weeks
Title
Fatigue
Description
Patients rated fatigue on VAS, 0-100.
Time Frame
Assessed at 0,6 and 14 weeks
Title
Disease impact on general well-being
Description
Patients rated impact on well-being on a VAS, 0-100.
Time Frame
Assessed at 0,6, and 14 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Alexanderson, PhD, RPT
Organizational Affiliation
Karolinska University Hospital / Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Univeristy Hospital, Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24507585
Citation
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.
Results Reference
derived

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

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