Training and Energy Management Education to Improve Quality of Life in Persons With Multiple Sclerosis

Klinik Valens

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Education; Behavioral: Endurance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04356248

2020-000769

Details and patient eligibility

About

Persons with Multiple Sclerosis (PwMS) often suffer from impaired mobility and reduced aerobic capacity. Moreover, 65% of PwMS recognize fatigue as their most disabling symptom that quickly impacts patients' health-related quality of life (QoL). Systematic reviews that evaluate therapeutic options for MS-neurorehabilitation show good evidence for exercise and energy management/conservation programs to improve fatigue or its impact on daily life. Guidelines recommend a multidisciplinary approach but to date only unimodal interventions are investigated. This study aims to investigate the influence of the combination of two different therapeutic concepts: inpatient energy management education (IEME) + High-intensity interval training (HIIT). This intervention is compared with a control group that undergoes progressive muscle relaxation (PMR) + low-intensity training (ST). IEME or PMR is performed on two days (tue-thur) and HIIT or ST on three days (mo-wed-fr) / week. The primary outcome is the effect on the quality of life after three weeks rehabilitation and after returning home (at 4 and 6 months follow-up) in PwMS.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Definite MS diagnosis (revised McDonald criteria, 2018).
• Age >18y
• Expanded Disability Status Scale (EDSS) score ≤ 6.5
• Fatigue Scale of Motor and Cognitive function (FSMC) total score > 43
• Literacy and understanding German
• Informed Consent

Exclusion criteria

• Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Cognitive impairment Mini-Mental State Examination (MMSE) < 21
• Major Depression or Hospital Anxiety and Depression Scale (HADS) >11 at baseline
• Stem cell treatment in the last 6 months
• Participation in a previous high-intensity interval training (HIIT) or inpatient energy management education (IEME) study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

High-intensity interval training + energy management education

Experimental group

Description:

* High-intensity interval training (HIIT): physiologically defined heart rate-controlled cycling with 80-100 rounds per minute (rpm) at 95-100% of maximum heart rate (HRmax). Participants will perform 5 × 1.5-min high-intensive exercise bouts at 95-100% of their HRmax followed by active breaks of unloaded pedalling over 2 min with the aim to achieve 60% of HRmax. * Energy management education (IEME): face-to-face education sessions of 6.5 h in duration over a 3-week period, all conducted by a trained occupational therapist. Participants acquire knowledge and understanding about factors that influence energy and the consequences of fatigue on their habits and lifestyle. Six weeks after returning home, the participants will receive a reinforcement letter in the form of information material to remember the content of the IEME and to reinforce the implementation of the behaviour change in managing energy.

Treatment:

Behavioral: Education

Behavioral: Endurance Training

Low-intensity training + progressive muscle relaxation

Active Comparator group

Description:

* Low-intensity training (ST): participants will exercise for 24 min continuously at 65% of participants' HRmax (60-70 rpm). * Progressive muscle relaxation (PMR): The aim of PMR is to achieve enhanced mental relaxation by reducing muscle tension. Participants will attend six 1-h group sessions over the 3-week intervention period, instructed by a trained physical therapist. Six weeks after returning home, the participants will receive a reinforcement letter with information material for remembering the content of the PMR techniques and to reinforce the implementation of the exercises at home.

Treatment:

Behavioral: Education

Behavioral: Endurance Training