Multiple SclerosisNCT04057066
Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis (Feasibility Study)
A study testing Physical activity counseling and Exercise in people with Multiple Sclerosis, run by University of Erlangen-Nürnberg at 3 sites in Germany.
Trial summary
This study evaluates the feasibility of a 12-week internet-based exercise and physical activity counseling intervention for people with Multiple Sclerosis (MS). 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?
- Physical activity counseling and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesGermany
- Study dates
- 28 Feb 2019to 16 Aug 2019
- 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)
- expanded Disability Status Scale between 0 - 6.5
- neurologically stable (no exacerbation within 30 days prior to enrollment)
- internet access (WiFi)
- basic knowledge on handling personal computer and the internet
- owning a smartphone with the operating system Android or IOS and with access to Google Play Store or Apple App score
- ability to read, write and comprehend as well as communicate electronically
- not regularly physically active (more than 30 minutes twice a week with a moderate intensity (includes aerobic training, resistance training and other sports e.g. Tennis; excludes physiotherapy, physical activity during work or household, grocery shopping, gardening, walking the dog etc.)
Who cannot join
- clinically relevant cardiovascular diseases
- cortisone therapy in the last 30 days
- cognitive impairment
- severe impairment of hand function (ataxia or paresis impeding the use of a smartphone app or smartwatch)
- severe internal, orthopaedic and metabolic diseases that restrict mobility
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Neurological Rehabilitation Center Quellenhof
Bad Wildbad, Baden-Wurttemberg, 75323
Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
Erlangen
Klinikum Würzburg Mitte gGmbH
Würzburg, Bavaria, 97070
About this study
Official title: Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis. A Feasibility Study.
This study evaluates the feasibility of a 12-week internet-based exercise and physical activity counseling intervention for people with Multiple Sclerosis (MS).
Read the detailed description
Due to high inactivity rates in persons with Multiple Sclerosis (pwMS) physical activity promotion for this target group is needed. The internet is an attractive and feasible medium for physical activity promotion, however interventions have to be adapted to the special needs of pwMS. This study aims to evaluate the feasibility of a 12-week internet-based exercise and physical activity counseling intervention.
26 pwMS will be enrolled in the study. All of them receive the intervention. Focus groups and interviews will be conducted with participating pwMS to determine acceptability of the intervention and to explore participants experiences. Compliance with the intervention will be monitored. Additionally, changes in objective physical activity, subjective physical activity, fatigue, walking ability and level of depression will be calculated.
- Conditions
- Multiple Sclerosis
- Being tested
- Physical activity counseling, Exercise
- Keywords
- multiple sclerosis, e-health, physical activity promotion, exercise, feasibility, online, internet based
- 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.
Physical activity counselingBehavioural
Physical activity counseling consists of two phone or video calls with a therapists, two group video calls with a therapist and a complementary e-learning course.
ExerciseBehavioural
Participants will agree with their therapist on an exercise plan (endurance and resistance training) that will be made available through the studies mobile app. Frequency and duration of endurance and strength training shall be prescribed in accordance with exercise guidelines for pwMS. However, they can be adjusted according to participants prior physical activity level and their available time slots for exercise during the week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive physical activity counseling as well as an individualized exercise plan. Receives: Behavioral: Physical activity counseling; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the Intervention and participants' experiences (focus groups)
Focus groups (1,5 hrs) with participants to determine extent to which they perceived intervention as appropriate.
Measured: 1 week after the end of the intervention
Compliance with intervention protocol (completed training sessions and e-learning modules)
Completed training sessions and e-learning modules will be documented for each participant with the interventions mobile app and e-learning course.
Measured: over the 12 weeks of intervention
Acceptability of the Intervention and participants' experiences (interviews)
With those participants that cannot take part in the focus groups, semistructured interviews (30 min) will be conducted to determine extent to which participants' perceived intervention as appropriate. Interview questions are based on focus group questions. The wording is slightly adapted to fit the interview situation.
Measured: 1 week after the end of the intervention
Secondary outcomes (5)
Changes in objectively measures physical activity
The physical activity level of participants is measured over a 7 day period with the accelerometer Actigraph GT3X+. The Actigraph GT3X+ measures acceleration on three axes. Steps per day, physical activity per day (activity counts) and time in moderate and vigorous physical activity per day will be calculated.
Measured: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Changes in subjectively measured physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ)
8-item questionnaire to assess time spent for work related physical activity, physical activity for transportation (walking, biking), muscle strengthening exercises and sports, fitness or recreational physical activity during a typical week.
Measured: 1 week before start of the intervention (T0), 1 week after end of the intervention (T1)
Würzburger Fatigue Inventory for MS (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: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Allgemeine Depressionsskala (ADS-L)
German version of the Center for Epidemiologic Studies Depression Scale, 20 item questionnaire. Each item is rated on a 4-point Likert scale. Answers are scored from 0 to 3. The scores for all items are added up to receive the total score. The total score ranges from 0 to 60 with higher scores representing higher levels of depression.
Measured: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Multiple Sclerosis Walking Scale-12
12-item questionnaire measuring self reported walking ability. Each item is answered on a 5-point Likert scale. Answers are scored from 1 to 5. The scores for all items are added up to receive a total score. The total score ranges from 12 to 60 with higher scores representing higher levels of depression. As a last step the total score is transformed into the walk12-score ranging from 0 to 100 ((total score -12)/48 x 100 = walk12-score).
Measured: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start28 Feb 2019
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- Neurological Rehabilitation Center Quellenhof, ZTM Bad Kissingen, Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie, proMX GmbH Nürnberg, motionNET systems Limited, Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V., Klinikum Würzburg Mitte GmbH
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
- Investigators
- Klaus Pfeifer, Prof. Dr., Principal investigator, Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Sport Science and SportPeter Flachenecker, Prof. Dr. med., Principal investigator, Neurological Rehabilitation Center QuellenhofMathias Mäurer, Prof. Dr. med., Principal investigator, Klinikum Würzburg Mitte gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057066
- Sponsor's protocol ID
- ms bewegt 1.2
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis. A Feasibility Study.
- ClinicalTrials.gov ID
- NCT04057066
- Acronym / sponsor ID
- ms bewegt 1.2
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, e-health, physical activity promotion, exercise, feasibility, online, internet based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- Neurological Rehabilitation Center Quellenhof, ZTM Bad Kissingen, Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie, proMX GmbH Nürnberg, motionNET systems Limited, Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V., Klinikum Würzburg Mitte GmbH
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 14 Aug 2019 (actual)
- 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.
This study evaluates the feasibility of a 12-week internet-based exercise and physical activity counseling intervention for people with Multiple Sclerosis (MS).
Detailed description
Due to high inactivity rates in persons with Multiple Sclerosis (pwMS) physical activity promotion for this target group is needed. The internet is an attractive and feasible medium for physical activity promotion, however interventions have to be adapted to the special needs of pwMS. This study aims to evaluate the feasibility of a 12-week internet-based exercise and physical activity counseling intervention.
26 pwMS will be enrolled in the study. All of them receive the intervention. Focus groups and interviews will be conducted with participating pwMS to determine acceptability of the intervention and to explore participants experiences. Compliance with the intervention will be monitored. Additionally, changes in objective physical activity, subjective physical activity, fatigue, walking ability and level of depression will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical activity counseling, Behavioral: ExerciseParticipants receive physical activity counseling as well as an individualized exercise plan. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosed Multiple Sclerosis (McDonald criteria)
- expanded Disability Status Scale between 0 - 6.5
- neurologically stable (no exacerbation within 30 days prior to enrollment)
- internet access (WiFi)
- basic knowledge on handling personal computer and the internet
Key exclusion criteria (5 listed)
- clinically relevant cardiovascular diseases
- cortisone therapy in the last 30 days
- cognitive impairment
- severe impairment of hand function (ataxia or paresis impeding the use of a smartphone app or smartwatch)
- severe internal, orthopaedic and metabolic diseases that restrict mobility
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 |
|---|---|---|
| Physical activity counselingPhysical activity counseling consists of two phone or video calls with a therapists, two group video calls with a therapist and a complementary e-learning course. | Behavioural | Intervention |
| ExerciseParticipants will agree with their therapist on an exercise plan (endurance and resistance training) that will be made available through the studies mobile app. Frequency and duration of endurance and strength training shall be prescribed in accordance with exercise guidelines for pwMS. However, they can be adjusted according to participants prior physical activity level and their available time slots for exercise during the week. | Behavioural | Intervention |
Primary outcome
Acceptability of the Intervention and participants' experiences (focus groups)
Time frame: 1 week after the end of the intervention
Focus groups (1,5 hrs) with participants to determine extent to which they perceived intervention as appropriate.
Compliance with intervention protocol (completed training sessions and e-learning modules)
Time frame: over the 12 weeks of intervention
Completed training sessions and e-learning modules will be documented for each participant with the interventions mobile app and e-learning course.
Acceptability of the Intervention and participants' experiences (interviews)
Time frame: 1 week after the end of the intervention
With those participants that cannot take part in the focus groups, semistructured interviews (30 min) will be conducted to determine extent to which participants' perceived intervention as appropriate. Interview questions are based on focus group questions. The wording is slightly adapted to fit the interview situation.
5 secondary outcomes
Changes in objectively measures physical activity
Time frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Changes in subjectively measured physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ)
Time frame: 1 week before start of the intervention (T0), 1 week after end of the intervention (T1)
Würzburger Fatigue Inventory for MS (WEIMuS)
Time frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Allgemeine Depressionsskala (ADS-L)
Time frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
Multiple Sclerosis Walking Scale-12
Time frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)
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 27 Apr 2020.
- Official description of the project on the website of the University of Erlangen-Nürnberg.Link provided by the sponsor.
- 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.
Klaus Pfeifer, Prof. Dr. principal investigator
Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Sport Science and Sport
Peter Flachenecker, Prof. Dr. med. principal investigator
Neurological Rehabilitation Center Quellenhof
Mathias Mäurer, Prof. Dr. med. principal investigator
Klinikum Würzburg Mitte gGmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity counseling and Exercise in people with Multiple Sclerosis, run by University of Erlangen-Nürnberg at 3 sites in Germany.
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 8 inclusion and 5 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 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Acceptability of the Intervention and participants' experiences (focus groups) (time frame: 1 week after the end of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2020.