Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: e-training; Other: Control

• Registration Number: NCT02771652
• Lead Sponsor: University of Erlangen-Nürnberg

Brief Summary

In this randomised controlled trial, the feasibility and effectiveness of an internet-based exercise intervention including progressive strength and endurance training (e-training) for PwMS was investigated. Primary outcome was health-related quality of life, secondary outcomes were muscle strength, aerobic capacity and lung function, physical activity and fatigue.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-06
• Study Completion: 2011-11
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-13
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• diagnosed Multiple Sclerosis (McDonald criteria),
• an EDSS score of less than or equal to 4.0,
• not less than 4 weeks of clinical stability prior to inclusion in the study,
• access to the internet.
• the taking of immunotherapeutic agents was not relevant and not monitored

Exclusion Criteria

• primary progressive multiple sclerosis
• clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
e-training intervention	e-training	Resistance and endurance training
Control	Control	no exercise

Primary Outcome Measures

Name	Time	Method
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)	Assessments took place at baseline and at 3 months	38 items generate the subscales of fatigue/thinking, mobility of the lower/upper extremities, communication and mood. The HAQUAMS total score is calculated from a mean of the subscales, providing a total score between 1 and 5. Higher scores in HAQUAMS indicate lower levels in HRQoL. The primary outcome will be the change over time from baseline to month 3.

Secondary Outcome Measures

Name	Time	Method
Aerobic capacity	Assessments took place at baseline and after 3 and 6 months	As a marker of endurance capacity, maximal oxygen uptake (VO2peak) was determined by the spiroergometry device Master Screen CPX on a bicycle ergometer (Sanabike 250F, MESA, Germany) at 70-80 revolutions per minute.
Würzburg Fatigue Scale (WEIMuS)	Assessments took place at baseline, at 3 and 6 months	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.
Muscle strength lower extremities	Assessments took place at baseline and after 3 and 6 months	Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).
Forced vital capacity	Assessments took place at baseline and after 3 and 6 months	Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
Physical activity	Assessments took place at baseline and after 3 and 6 months	Habitual physical activity was assessed with the German version of the Baecke Questionnaire including three activity indices (work, sport, leisure time PA). There were limitations concerning content validity in all indices; therefore, the sport score of the sport index was used. That score is the product of the intensity, duration and frequency of a participant's reported sports activities. Higher scores indicate a higher level of PA.
Peak expiratory flow	Assessments took place at baseline and after 3 and 6 months	Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).