Fatigue in Multiple SclerosisPhase 4PACENCT01490840
Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis
A Phase 4 study testing Physical exercise in people with Fatigue in Multiple Sclerosis, run by Novartis Pharmaceuticals at 32 sites in Germany.
Trial summary
This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue in Multiple Sclerosis
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 32 sitesGermany
- Study dates
- Nov 2011to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
- Patients with Expanded Disability Status Scale (EDSS) score of 0-3.5 (including)
- Immunomodulatory treatment with prescribed fingolimod for at least one month prior to baseline
- Fatigue score assessed by mFIS of equal or greater than 14 at screening
- Neurologically stable with no evidence of relapse within 30 days prior to inclusion date
Who cannot join
- Patients who have been treated with:
- systemic corticosteroids or immunoglobulins within 1 month prior to randomization;
- immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to randomization;
- monoclonal antibodies (including natalizumab) within 3 months prior to randomization;
- mitoxantrone within 6 months prior to randomization
- cladribine at any time.
Show all 22Show fewer
- Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
- Patients with any of the following cardiovascular conditions :
- history of cardiac arrest;
- history of myocardial infarction or with current unstable ischemic heart disease;
- history of angina pectoris due to coronary spasm or history of Raynaud syndrome
- Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the investigator;
- history or presence of a second-degree AV block, Type II or a third-degree AV
- block
- patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or
- III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide,
- dofelitide);
- proven history of sick sinus syndrome or sino-atrial heart block;
- uncontrolled hypertension
- Clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases (e.g. scoliosis) that might interfere with physical training
- Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Germany32 sites
Novartis Investigative Site
Aachen, 52062
Novartis Investigative Site
Alzenau in Unterfranken, 63755
Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Bad Mergentheim, 97980
Novartis Investigative Site
Bamberg, 96052
Novartis Investigative Site
Bayreuth, 95445
Novartis Investigative Site
Berlin, 10437
Novartis Investigative Site
Berlin, 10625
Novartis Investigative Site
Berlin, 10691
Novartis Investigative Site
Berlin, 12587
Novartis Investigative Site
Berlin, 13347
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Böblingen, 71032
Novartis Investigative Site
Bochum, 44787
Novartis Investigative Site
Dortmund, Germany, 44135
Novartis Investigative Site
Erbach im Odenwald, 64711
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt, 65929
Novartis Investigative Site
Hamburg, 22179
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Kassel, 34121
Novartis Investigative Site
Leipzig, Germany, 04299
Novartis Investigative Site
Potsdam, 14471
Novartis Investigative Site
Prien am Chiemsee, 83209
Novartis Investigative Site
Regensburg, 93053
Novartis Investigative Site
Siegen, 57076
Novartis Investigative Site
Sinsheim, 74889
Novartis Investigative Site
Stuttgart, 70174
Novartis Investigative Site
Stuttgart, 70178
Novartis Investigative Site
Teupitz, 15755
Novartis Investigative Site
Unterhaching, 82008
About this study
Official title: A 6-month, Multicenter, Randomized, Controlled Parallel Group Study to Evaluate the Effect of Physical Training on Fatigue in Patients With Relapsing-remitting Multiple Sclerosis Treated With Fingolimod, Followed by a 6 Month Optional Extension Phase
This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.
Read the detailed description
In this study, it was planned to randomize 226 participants. However, only 178 participants were randomized during a timeframe of 2 years and 8 months. Therefore, the study was terminated due to slow enrollment and low participant compliance to the physical training schedule.
- Conditions
- Fatigue in Multiple Sclerosis
- Being tested
- Physical exercise
- Keywords
- Fatigue, MS, Multiple Sclerosis, Exercise, Physical activity, Physical training, Fingolimod
- Medical subject headings
- Fatigue, Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
Strength training exercises are performed against own body weight or with training aids like elastic rubber bands or gym balls. All exercises are home-based. To increase balance and core stability, a subset of exercises is performed on shaky ground and/or one-legged. Exercise intensity, duration and frequency are individually assigned by a sports therapist. For each muscle group, a set of exercises of increasing difficulty allows for individual and progressive training adaption. Therapists can choose from an exercise database of approximately 150 different strength exercises with different graduation.
| Study group | Role | What they receive |
|---|---|---|
| E-training | Experimental | Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied. Receives: Other: Physical exercise |
| Waiting | Experimental | Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 months waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. Receives: Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).
The mFIS provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. It is a 21-item, structured, self-report questionnaire that generally can be completed with little or no intervention from an interviewer. The mFIS score ranged from 0 (not tired) to 84 (tired). A negative change from baseline indicates improvement.
Measured: Baseline, 6 months
Secondary outcomes (8)
Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test
The Sit to Stand Test is a functional outcome measure of the lower-extremity muscle power. The test was performed 3 times with one minute rest in between. The best attempt out of three was used for the analysis. A positive change from baseline indicates improvement.
Measured: baseline, 6 months
Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength
Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).
Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement.
Measured: baseline, 6 months
Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance
Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).
Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement.
Measured: baseline, 6 months
Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)
The Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) consists of 44 items, 28 of which are the basis for computation of five subscale scores reflecting major dimensions of health-related quality of life (HRQoL) in MS: Fatigue/Thinking (4 items), Mobility lower limb (5 items), Mobility upper limb (5 items), Social function (6 items) and Mood (eight items). Subscales and total score range from 1 to 5, with high scores indicating a lower quality of life. In this study, the total score and following 3 subscales: fatigue/thinking, mobility lower limb and mobility upper limb only were analyzed. A negative change from baseline indicates improvement.
Measured: Baseline, 6 months, 12 months
Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)
The WEIMuS (Würzburg Fatigue Inventory for MS) scale is a validated self-assessment instrument to quantify the degree of fatigue. The scale consists of 17 items with 5 categories that are scored from '0' to '4'. The subscores for cognitive and physical fatigue range from 0 to 36 and from 0 to 32, respectively, with the total sum score ranging from 0 to 68; higher scores indicate higher degrees of fatigue. A negative change from baseline indicates improvement.
Measured: Baseline, 6 months
Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)
The Beck Depression Inventory Second Edition (BDI-II) is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders Fourth Edition. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the BDI-II. There is a four-point scale for each item ranging from 0 to 3. The total score ranges from 0 - 63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. A negative change from baseline indicates improvement.
Measured: Baseline, 6 months
Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill
Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A negative change from baseline indicates improvement.
Measured: Baseline, 6 months
Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill
Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A positive change from baseline indicates improvement.
Measured: Baseline, 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 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: The study stopped due to slow enrollment and low participant compliance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatigue in Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490840
- Sponsor's protocol ID
- CFTY720DDE07
- Other IDs
- 2011-002969-38
- Acronym
- PACE
- Status last verified
- Apr 2016
- First submitted
- 9 Dec 2011
- Last updated
- 12 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Maurer M, Schuh K, Seibert S, Baier M, Hentschke C, Streber R, Tallner A, Pfeifer K. A randomized study to evaluate the effect of exercise on fatigue in people with relapsing-remitting multiple sclerosis treated with fingolimod. Mult Scler J Exp Transl Clin. 2018 Feb 14;4(1):2055217318756688. doi: 10.1177/2055217318756688. eCollection 2018 Jan-Mar.
PubMed 29479457
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Multicenter, Randomized, Controlled Parallel Group Study to Evaluate the Effect of Physical Training on Fatigue in Patients With Relapsing-remitting Multiple Sclerosis Treated With Fingolimod, Followed by a 6 Month Optional Extension Phase
- ClinicalTrials.gov ID
- NCT01490840
- Acronym / sponsor ID
- PACE / CFTY720DDE07
- Conditions
- Fatigue in Multiple Sclerosis
- Keywords
- Fatigue, MS, Multiple Sclerosis, Exercise, Physical activity, Physical training, Fingolimod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped due to slow enrollment and low participant compliance.
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.
Detailed description
In this study, it was planned to randomize 226 participants. However, only 178 participants were randomized during a timeframe of 2 years and 8 months. Therefore, the study was terminated due to slow enrollment and low participant compliance to the physical training schedule.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-training | Experimental | Other: Physical exerciseFingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied. |
| Waiting | Experimental | Other: Physical exerciseFingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 months waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
- Patients with Expanded Disability Status Scale (EDSS) score of 0-3.5 (including)
- Immunomodulatory treatment with prescribed fingolimod for at least one month prior to baseline
- Fatigue score assessed by mFIS of equal or greater than 14 at screening
- Neurologically stable with no evidence of relapse within 30 days prior to inclusion date
Key exclusion criteria (22 listed)
- Patients who have been treated with:
- Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
- Patients with any of the following cardiovascular conditions :
- Clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases (e.g. scoliosis) that might interfere with physical training
- Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion
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 exerciseStrength training exercises are performed against own body weight or with training aids like elastic rubber bands or gym balls. All exercises are home-based. To increase balance and core stability, a subset of exercises is performed on shaky ground and/or one-legged. Exercise intensity, duration and frequency are individually assigned by a sports therapist. For each muscle group, a set of exercises of increasing difficulty allows for individual and progressive training adaption. Therapists can choose from an exercise database of approximately 150 different strength exercises with different graduation. | Other | E-training, Waiting |
Primary outcome
Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).
Time frame: Baseline, 6 months
The mFIS provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. It is a 21-item, structured, self-report questionnaire that generally can be completed with little or no intervention from an interviewer. The mFIS score ranged from 0 (not tired) to 84 (tired). A negative change from baseline indicates improvement.
8 secondary outcomes
Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test
Time frame: baseline, 6 months
Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength
Time frame: baseline, 6 months
Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance
Time frame: baseline, 6 months
Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)
Time frame: Baseline, 6 months, 12 months
Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)
Time frame: Baseline, 6 months
Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)
Time frame: Baseline, 6 months
Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill
Time frame: Baseline, 6 months
Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29479457Maurer M, Schuh K, Seibert S, Baier M, Hentschke C, Streber R, Tallner A, Pfeifer K. A randomized study to evaluate the effect of exercise on fatigue in people with relapsing-remitting multiple sclerosis treated with fingolimod. Mult Scler J Exp Transl Clin. 2018 Feb 14;4(1):2055217318756688. doi: 10.1177/2055217318756688. eCollection 2018 Jan-Mar.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physical exercise in people with Fatigue in Multiple Sclerosis, run by Novartis Pharmaceuticals at 32 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 5 inclusion and 22 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: stopped early, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ). (time frame: Baseline, 6 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 NCT01490840, 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 12 May 2016.