Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Danish MS Society | UNKNOWN |
| Danish MS Hospitals, Haslev and Ry | OTHER |
| Aarhus University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. The purpose of this study is therefore to evaluate the feasibility of endurance training in severely disabled patients with MS.
For many years, patients with multiple sclerosis (MS) have been advised not to participate in physical exercise. This advice was given in part because some patients were reported to experience symptom instability during exercise as a consequence of increased body temperature. A further argument was that avoiding exercise would preserve energy and thereby result in less fatigue, leaving more energy for activities of daily living. During the last decade, it has been more common to recommend exercise for MS patients, because of its recently proven beneficial effects in these patients.
Resistance- and endurance training constitutes the two extremes of basic physical exercise. To gain insight into the effects of exercise it therefore makes sense to understand the extremes. In mild to moderately impaired MS patients endurance training is well tolerated and providing beneficial effects. However, this exercise modality has not yet been tested in severely disabled patients, and it is therefore unclear if endurance training is feasible and beneficial in these patients. The investigators have, therefore, designed a feasibility study evaluating the effects of 4 weeks of endurance training in severely disabled MS patients (Expanded Disability Status Scale score > 6).
Patients are inpatients at one of the national MS hospitals and endurance training is added to the usual care, and compared to usual care only (control group). Exercise frequency is 3 times per week, and intensity is controlled by HR measurements during exercise.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endurance training | Experimental | Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity. |
|
| Standard care | Active Comparator | Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurance training | Behavioral | Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise compliance | Compliance to exercise is registered and serve as the primary outcome. | Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention |
| Drop out rate | Number of participants who drop out is registered at the post measurement just after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen consumption | Measurement of peak oxygen consumption during a ramp protocol on armergometer. | 1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured |
| Box and Block test |
Not provided
Inclusion Criteria:
Signed informed consent
->18 years
Primary progressive or secondary progressive MS according to the McDonald criteria
6.5 ≤ EDSS ≤ 8.0 and pyramidal score between 1 and 4
Maximal walking distance ≤ 10m
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ulrik Dalgas, PhD | Dep. Public Health, Aarhus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Hospital in Ry | Ry | Jylland | 8680 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24057428 | Derived | Skjerbaek AG, Naesby M, Lutzen K, Moller AB, Jensen E, Lamers I, Stenager E, Dalgas U. Endurance training is feasible in severely disabled patients with progressive multiple sclerosis. Mult Scler. 2014 Apr;20(5):627-30. doi: 10.1177/1352458513505351. Epub 2013 Sep 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000076663 | Endurance Training |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard care | Behavioral | Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center. |
|
| 1-2 day before the intervention and 1-2days after the 4 week intervention the box and block test is performed |
| Sit to stand test | 1-2 day before the intervention and 1-2days after the 4 week intervention the sit to stand test is performed |
| Handgrip test | 1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed |
| Wheel-chair test | 1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |