Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients (ms-intakt)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
e-training
Control
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Quality of Life, exercise, internet
Eligibility Criteria
Inclusion Criteria:
- diagnosed Multiple Sclerosis (McDonald criteria),
- an EDSS score of less than or equal to 4.0,
- not less than 4 weeks of clinical stability prior to inclusion in the study,
- access to the internet.
- the taking of immunotherapeutic agents was not relevant and not monitored
Exclusion Criteria:
- primary progressive multiple sclerosis
- clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
e-training intervention
Control
Arm Description
Resistance and endurance training
no exercise
Outcomes
Primary Outcome Measures
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
38 items generate the subscales of fatigue/thinking, mobility of the lower/upper extremities, communication and mood. The HAQUAMS total score is calculated from a mean of the subscales, providing a total score between 1 and 5. Higher scores in HAQUAMS indicate lower levels in HRQoL. The primary outcome will be the change over time from baseline to month 3.
Secondary Outcome Measures
Würzburg Fatigue Scale (WEIMuS)
This questionnaire contains 17 items that form a physical and cognitive subscale. The total score ranges from zero to a maximum of 68 points (maximum fatigue). The cut-off value for the presence of fatigue is above 32.
Muscle strength lower extremities
Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).
Forced vital capacity
Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
Aerobic capacity
As a marker of endurance capacity, maximal oxygen uptake (VO2peak) was determined by the spiroergometry device Master Screen CPX on a bicycle ergometer (Sanabike 250F, MESA, Germany) at 70-80 revolutions per minute.
Physical activity
Habitual physical activity was assessed with the German version of the Baecke Questionnaire including three activity indices (work, sport, leisure time PA). There were limitations concerning content validity in all indices; therefore, the sport score of the sport index was used. That score is the product of the intensity, duration and frequency of a participant's reported sports activities. Higher scores indicate a higher level of PA.
Peak expiratory flow
Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
Full Information
NCT ID
NCT02771652
First Posted
May 4, 2016
Last Updated
June 23, 2016
Sponsor
University of Erlangen-Nürnberg
Collaborators
Caritas-Krankenhaus Bad Mergentheim
1. Study Identification
Unique Protocol Identification Number
NCT02771652
Brief Title
Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients
Acronym
ms-intakt
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg
Collaborators
Caritas-Krankenhaus Bad Mergentheim
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this randomised controlled trial, the feasibility and effectiveness of an internet-based exercise intervention including progressive strength and endurance training (e-training) for PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes were muscle strength, aerobic capacity and lung function, physical activity and fatigue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Quality of Life, exercise, internet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
e-training intervention
Arm Type
Active Comparator
Arm Description
Resistance and endurance training
Arm Title
Control
Arm Type
Other
Arm Description
no exercise
Intervention Type
Behavioral
Intervention Name(s)
e-training
Intervention Description
The e-training intervention is a home-based aerobic and resistance training program. Resistance training was prescribed twice weekly for a period of 12 weeks. No special equipment was necessary except an elastic exercise band or a large gymnastic ball. In addition, endurance training was to be carried out once a week. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels. Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard). The exercise training was home-based and supervised via the internet. Participants continued exercise training for another 12 weeks after the 3month assessment.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour. After waiting three months, they received the same e-training intervention as the intervention group had received from the start.
Primary Outcome Measure Information:
Title
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
Description
38 items generate the subscales of fatigue/thinking, mobility of the lower/upper extremities, communication and mood. The HAQUAMS total score is calculated from a mean of the subscales, providing a total score between 1 and 5. Higher scores in HAQUAMS indicate lower levels in HRQoL. The primary outcome will be the change over time from baseline to month 3.
Time Frame
Assessments took place at baseline and at 3 months
Secondary Outcome Measure Information:
Title
Würzburg Fatigue Scale (WEIMuS)
Description
This questionnaire contains 17 items that form a physical and cognitive subscale. The total score ranges from zero to a maximum of 68 points (maximum fatigue). The cut-off value for the presence of fatigue is above 32.
Time Frame
Assessments took place at baseline, at 3 and 6 months
Title
Muscle strength lower extremities
Description
Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).
Time Frame
Assessments took place at baseline and after 3 and 6 months
Title
Forced vital capacity
Description
Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
Time Frame
Assessments took place at baseline and after 3 and 6 months
Title
Aerobic capacity
Description
As a marker of endurance capacity, maximal oxygen uptake (VO2peak) was determined by the spiroergometry device Master Screen CPX on a bicycle ergometer (Sanabike 250F, MESA, Germany) at 70-80 revolutions per minute.
Time Frame
Assessments took place at baseline and after 3 and 6 months
Title
Physical activity
Description
Habitual physical activity was assessed with the German version of the Baecke Questionnaire including three activity indices (work, sport, leisure time PA). There were limitations concerning content validity in all indices; therefore, the sport score of the sport index was used. That score is the product of the intensity, duration and frequency of a participant's reported sports activities. Higher scores indicate a higher level of PA.
Time Frame
Assessments took place at baseline and after 3 and 6 months
Title
Peak expiratory flow
Description
Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
Time Frame
Assessments took place at baseline and after 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed Multiple Sclerosis (McDonald criteria),
an EDSS score of less than or equal to 4.0,
not less than 4 weeks of clinical stability prior to inclusion in the study,
access to the internet.
the taking of immunotherapeutic agents was not relevant and not monitored
Exclusion Criteria:
primary progressive multiple sclerosis
clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Mäurer, Dr.
Organizational Affiliation
Caritas-Krankenhaus Bad Mergentheim
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
Tallner A, Tzschoppe R,Peters S, Mäurer M, Pfeifer K. Internetgestützte Bewegungsförderung bei Personen mit Multipler Sklerose. Neurologie und Rehabilitation 19(1): 35-46, 2013.
Results Reference
background
Links:
URL
http://www.zentrum-patientenschulung.de/manuale/schulung/index.php?schulungen_id=186
Description
certified as patient education program (german)
Available IPD and Supporting Information:
Available IPD/Information Type
Detailed intervention description
Available IPD/Information URL
https://www.sport.fau.de/files/2016/05/ms-intakt-e-training-intervention-description.pdf
Available IPD/Information Comments
Detailed description of the processes of the e-training intervention (english language)
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.sport.fau.de/files/2015/05/ms-intakt-abschlussbericht-19_05_2015.pdf
Available IPD/Information Comments
Final report for funding foundation (german)
Learn more about this trial
Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients
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