A randomized study to evaluate the effect of exercise on fatigue in people with relapsing–remitting multiple sclerosis treated with fingolimod

Background Fatigue is a major symptom of multiple sclerosis (MS) in patients, and it has been shown to improve with physical exercise. Although fingolimod might lessen fatigue, it is unclear how patients treated with fingolimod react to physical activity regarding fatigue. Objective This study evaluated the effect of an exercise intervention on fatigue in relapsing–remitting MS patients receiving fingolimod. Methods People with MS (PwMS) were randomized to either a structured internet-based exercise program (e-training) or no e-training intervention. The primary endpoint was the change in the Modified Fatigue Impact Scale (mFIS) after six months. Results The primary analysis showed no statistically significant difference between groups in the mFIS change. Subgroup analyses revealed a beneficial effect of physical exercise for PwMS with low aerobic capacity and with low aerobic capacity plus more severe fatigue. The incidence of adverse events was similar in both groups. No cardiovascular events were reported. The majority of PwMS were relapse free. Conclusion Physical exercise benefits on fatigue may depend on the physical capacity of the patient and requires individualized training. Consistent with previous studies, these results suggest that physical exercise generally does not impose a risk and that this holds true also for patients receiving fingolimod

Förderung und Wirkungen der körperlich-sportlichen Aktivität bei Personen mit Multipler Sklerose

Diese kumulative Dissertation umfasst vier Manuskripte. Übergeordnetes Thema stellt die Förderung der körperlich-sportlichen Aktivität von Personen mit MS (PmMS) dar. Im Speziellen wurden zwei Forschungsfragestellungen bearbeitet. Forschungsfrage 1 fokussiert auf die Einflussfaktoren der körperlich-sportlichen Aktivität von PmMS. Mittels einer systematischen Übersichtsarbeit wurden Zusammenhänge zwischen krankheitsspezifischen, personbezogenen wie umweltbezogenen Faktoren und dem körperlichen Aktivitätsverhalten von PmMS untersucht. Es wurden wesentliche Einflussfaktoren und Personengruppen identifiziert, bei denen ein spezifischer Handlungsbedarf der Bewegungsförderung besteht. Darüber hinaus wurden Forschungslücken bzw. -bedarfe herausgearbeitet. Forschungsfrage 2 fokussiert auf die Konzeption, Realisation sowie Evaluation der Machbarkeit und Wirksamkeit einer internetbasierten, bewegungstherapeutischen Intervention für erwachsene PmMS. Hierzu wurden drei Manuskripte vorgelegt. Zwei Manuskripte beschreiben die Methodik und die Ergebnisse aus zwei randomisiert-kontrollierten Studien. Das letzte Manuskript beschreibt die konzeptionelle Weiterentwicklung der bisherigen Intervention zu einem Tele-Rehanachsorgeprogramm. Besonders erwähnenswerte Elemente der Weiterentwicklung stellen die Integration des Modells der bewegungsbezogenen Gesundheitskompetenz und der Selbstbestimmungstheorie sowie die Integration evidenzbasierter Techniken der Verhaltensänderung dar. Mit dem vorliegenden Konzept werden aktuelle Empfehlungen zur Bewegungsförderung aufgegriffen, wie sie für Menschen mit chronischen, nicht-übertragbaren Erkrankung in der Lebenswelt der gesundheitlichen Versorgung formuliert wurden. Die entwickelte internetbasierte Intervention bietet sich als geeignetes Medium an, um Zugangsbarrieren zu überwinden sowie eine große Anzahl an PmMS orts- wie zeitunabhängig zu betreuen und stellt eine flexible, individuelle und flächendeckende Lösung dar, um die bestehende Versorgungslücke im Kontext der Rehabilitationsnachsorge wie im ambulanten Setting für PmMS zu schließen

Exercise therapy in medical rehabilitation: Study protocol of a national survey at facility and practitioner level with a mixed method design

Background: The importance of physical activity and the orientation of exercise therapy in rehabilitation has changed for many chronic health conditions. Exercise therapy is the most applied therapy form within multidisciplinary rehabilitation programs for almost all chronic health conditions. Despite the scientifically discussed need to refine exercise therapy, there is relatively little knowledge of how exercise therapy is actually conducted. This study protocol describes the methodological procedure used in the project “Exercise therapy in medical rehabilitation: a survey at facility and practitioner level”, which aims to take a national survey of exercise therapy in rehabilitation practice in Germany. Methods: The project was implemented using an explanatory sequential mixed method design. Quantitative and qualitative methods were integrated in two consecutive project phases. Phase 1 used a standardized, quantitative written survey of the heads of exercise therapy departments to compile a national overview of concepts and process features of exercise therapy of individual rehabilitation facilities. Phase 2 recorded individual perspectives and opinions concerning exercise therapy goals, content and methods and current developments in the rehabilitation context (e.g., physical activity promotion, interdisciplinarity, standardization) of exercise therapy practitioners. Over the course of two one-and-a-half day workshops, central themes were introduced and prepared with standardized written individual surveys from Phase 1 and combined with qualitative surveys using facilitated group discussions (focus groups in mixed methods design). Discussion: The project generates a comprehensive picture of exercise therapy in medical rehabilitation at facility level and inserts further information at the practitioner level into this context. The chosen methodology of a mixed method design combines the perspective of the facility with that of the practitioner, thus allowing for a complex and multifaceted description of the status quo in exercise therapy practice and makes it possible to identify facilitators and barriers for the refinement of exercise therapy in specific everyday rehabilitation. These findings form the basis for the systematic development of quality exercise therapy in rehabilitation, in particular in terms of the refinement, implementation and dissemination of biopsychosocial concepts of exercise therapy. Keywords: Physical activity, Health services, Chronic disease, Therapy concept, Therapy proces

Internet-Supported Physical Exercise Training for Persons with Multiple Sclerosis—A Randomised, Controlled Study

Physical exercise is effective in improving functional outcomes in persons with multiple sclerosis (pwMS). We evaluated the feasibility and effectiveness of internet-based exercise training (e-training) for pwMS on health-related quality of life (HrQoL). Secondary outcomes were muscle strength, aerobic capacity, lung function, physical activity, and fatigue. This is a randomised, controlled trial with a wait-list control group. Data were collected at baseline, after three and six months, and analysed using a hybrid linear model. One-hundred twenty-six pwMS participated in the home-based aerobic (1×/week) and strength training (2×/week) intervention that was supervised and documented via an internet-platform. The intervention group received e-training for six months, and the control group received e-training after a three months waiting period. Significant differences between the groups were only observed for muscle strength (knee flexion (effect size ES = 0.3, p = 0.003), knee extension (ES = 0.24, p = 0.015)), peak expiratory flow (ES = 0.2, p = 0.039), and sports activity (ES = 0.33, p = 0.001) after three months. E-training had no effect on HrQoL but did on muscle strength, lung function, and physical activity. It is a promising and feasible approach to facilitate large-scale, yet individual, training support

A randomized study to evaluate the effect of exercise on fatigue in people with relapsing–remitting multiple sclerosis treated with fingolimod

Background Fatigue is a major symptom of multiple sclerosis (MS) in patients, and it has been shown to improve with physical exercise. Although fingolimod might lessen fatigue, it is unclear how patients treated with fingolimod react to physical activity regarding fatigue. Objective This study evaluated the effect of an exercise intervention on fatigue in relapsing–remitting MS patients receiving fingolimod. Methods People with MS (PwMS) were randomized to either a structured internet-based exercise program (e-training) or no e-training intervention. The primary endpoint was the change in the Modified Fatigue Impact Scale (mFIS) after six months. Results The primary analysis showed no statistically significant difference between groups in the mFIS change. Subgroup analyses revealed a beneficial effect of physical exercise for PwMS with low aerobic capacity and with low aerobic capacity plus more severe fatigue. The incidence of adverse events was similar in both groups. No cardiovascular events were reported. The majority of PwMS were relapse free. Conclusion Physical exercise benefits on fatigue may depend on the physical capacity of the patient and requires individualized training. Consistent with previous studies, these results suggest that physical exercise generally does not impose a risk and that this holds true also for patients receiving fingolimod

Efficacy of an Internet-Based Program to Promote Physical Activity and Exercise after Inpatient Rehabilitation in Persons with Multiple Sclerosis: A Randomized, Single-Blind, Controlled Study

Background: Multimodal rehabilitation improves fatigue and mobility in persons with multiple sclerosis (PwMS). Effects are transient and may be conserved by internet-based physical activity promotion programs. Objective: Evaluate the effects of internet-based physical activity and exercise promotion on fatigue, quality of life, and gait in PwMS after inpatient rehabilitation. Methods: PwMS (Expanded Disability Status Scale (EDSS) ≤ 6.0, fatigue: Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) ≥ 32) were randomized into an intervention group (IG) or a control group (CG). After rehabilitation, IG received 3 months of internet-based physical activity promotion, while CG received no intervention. Primary outcome: self-reported fatigue (WEIMuS). Secondary outcomes: quality of life (Multiple Sclerosis Impact Scale 29, MSIS-29), gait (2min/10m walking test, Tinetti score). Measurements: beginning (T0) and end (T1) of inpatient rehabilitation, 3 (T2) and 6 (T3) months afterwards. Results: 64 of 84 PwMS were analyzed (IG: 34, CG: 30). After rehabilitation, fatigue decreased in both groups. At T2 and T3, fatigue increased again in CG but was improved in IG (p < 0.001). MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG. Gait improvements were more pronounced in IG at T2. Conclusions: The study provides Class II evidence that the effects of rehabilitation on fatigue, quality of life, and gait can be maintained for 3–6 months with an internet-based physical activity and exercise promotion program

Effects of a brief, pedometer-based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6-week and 6-month objectively measured physical activity: study protocol for a randomized controlled trial

Abstract Background Pulmonary rehabilitation programs often fail to substantially enhance long-term physical activity in patients with chronic obstructive pulmonary disease (COPD). The reasons for successful physical activity changes in patients with COPD are not well understood. The need to better understand the determinants of physical activity in patients with COPD and effective rehabilitation strategies to improve physical activity is evident. Methods/design The STAR study (Stay Active after Rehabilitation) investigates, in a randomized controlled trial, the additional effect of a pedometer-based behavior-change intervention during inpatient pulmonary rehabilitation on objectively measured physical activity 6 weeks and 6 months post rehabilitation. The intervention uses the behavior-change techniques (1) instruction on how, where and when to perform the behavior, (2) prompt goal setting for physical activity, (3) prompt self-monitoring of behavior, and (4) feedback on behavior. The primary outcome of physical activity will be measured using a physical activity monitor (Actigraph wGT3X-BT) for a period of 7 days, firstly 2 weeks before rehabilitation begins (t0) as well as 6 weeks and 6 months after rehabilitation (t3, t4). Additionally, to predict physical activity progression after rehabilitation, a complex personal diagnostics battery, including questionnaires as well as functional assessments, is to be carried out at the start and end of rehabilitation (t1, t2). This battery is based on the foundational ideas of the Physical Activity-Related health Competence model. Five hundred and two patients with COPD, aged 18 years or older and admitted for an approved pulmonary rehabilitation, will be enrolled in the STAR study. Discussion The STAR study is designed as a randomized controlled trial to gain a better understanding of the personal determinants of physical activity in patients with COPD and to evaluate a pedometer-based physical activity-change intervention in the context of inpatient pulmonary rehabilitation. The results enable the future identification of patients with COPD who will find it difficult to engage in long-term physical activity after rehabilitation. Based on this, intervention strategies to promote physical activity in the content of pulmonary rehabilitation can be optimized. Trial registration Clinicaltrials.gov, ID: NCT02966561 . Registered retrospectively after the start of the recruitment in June 2016 on 22 November 2016. All protocol modifications will be registered in the trial registry