Multiple Sclerosisms-intaktNCT02771652
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
A study testing e-training in people with Multiple Sclerosis, run by University of Erlangen-Nürnberg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- e-training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- primary progressive multiple sclerosis
- clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- e-training, Control
- Keywords
- Multiple Sclerosis, Quality of Life, exercise, internet
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-trainingBehavioural
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| e-training intervention | Active comparator | Resistance and endurance training Receives: Behavioral: e-training |
| Control | Other | no exercise Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessments took place at baseline and at 3 months
Secondary outcomes (6)
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.
Measured: Assessments took place at baseline, at 3 and 6 months
Muscle strength lower extremities
Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).
Measured: Assessments took place at baseline and after 3 and 6 months
Forced vital capacity
Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
Measured: Assessments took place at baseline and after 3 and 6 months
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.
Measured: Assessments took place at baseline and after 3 and 6 months
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.
Measured: Assessments took place at baseline and after 3 and 6 months
Peak expiratory flow
Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
Measured: Assessments took place at baseline and after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- Caritas-Krankenhaus Bad Mergentheim
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Investigators
- Matthias Mäurer, Dr., Principal investigator, Caritas-Krankenhaus Bad Mergentheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771652
- Sponsor's protocol ID
- 1.01.1/09/007
- Acronym
- ms-intakt
- Status last verified
- Jun 2016
- First submitted
- 4 May 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02771652
- Acronym / sponsor ID
- ms-intakt / 1.01.1/09/007
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Quality of Life, exercise, internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- Caritas-Krankenhaus Bad Mergentheim
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-training intervention | Active comparator | Behavioral: e-trainingResistance and endurance training |
| Control | Other | Other: Controlno exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- primary progressive multiple sclerosis
- clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-trainingThe 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. | Behavioural | e-training intervention |
| ControlAfter 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. | Other | Control |
Primary outcome
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
Time frame: Assessments took place at baseline and at 3 months
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.
6 secondary outcomes
Würzburg Fatigue Scale (WEIMuS)
Time frame: Assessments took place at baseline, at 3 and 6 months
Muscle strength lower extremities
Time frame: Assessments took place at baseline and after 3 and 6 months
Forced vital capacity
Time frame: Assessments took place at baseline and after 3 and 6 months
Aerobic capacity
Time frame: Assessments took place at baseline and after 3 and 6 months
Physical activity
Time frame: Assessments took place at baseline and after 3 and 6 months
Peak expiratory flow
Time frame: Assessments took place at baseline and after 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- BackgroundTallner A, Tzschoppe R,Peters S, Mäurer M, Pfeifer K. Internetgestützte Bewegungsförderung bei Personen mit Multipler Sklerose. Neurologie und Rehabilitation 19(1): 35-46, 2013.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Mäurer, Dr. principal investigator
Caritas-Krankenhaus Bad Mergentheim
Questions about this trial
What is this clinical trial studying?
A study testing e-training in people with Multiple Sclerosis, run by University of Erlangen-Nürnberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS) (time frame: Assessments took place at baseline and at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016; AzTrials last refreshed its copy on 31 Oct 2026.