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

NCT02771652 | Completed

• 1 other identifier: 1.01.1/09/007
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Quality of Life; exercise; internet

Outcome Measures

Primary Outcomes (1)

• Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)

  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.

  Assessments took place at baseline and at 3 months

Secondary Outcomes (6)

• Würzburg Fatigue Scale (WEIMuS)

  Assessments took place at baseline, at 3 and 6 months

• Muscle strength lower extremities

  Assessments took place at baseline and after 3 and 6 months

• Forced vital capacity

  Assessments took place at baseline and after 3 and 6 months

• Aerobic capacity

  Assessments took place at baseline and after 3 and 6 months

• Physical activity

  Assessments took place at baseline and after 3 and 6 months

Study Arms (2)

e-training intervention

ACTIVE COMPARATOR

Resistance and endurance training

Behavioral: e-training

Control

OTHER

no exercise

Other: Control

Interventions

e-training BEHAVIORAL

The e-training intervention is a home-based aerobic and resistance training program. Resistance training was prescribed twice weekly for a period of 12 weeks. No special equipment was necessary except an elastic exercise band or a large gymnastic ball. In addition, endurance training was to be carried out once a week. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels. Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard). The exercise training was home-based and supervised via the internet. Participants continued exercise training for another 12 weeks after the 3month assessment.

e-training intervention

Control OTHER

After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour. After waiting three months, they received the same e-training intervention as the intervention group had received from the start.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed Multiple Sclerosis (McDonald criteria),
• an EDSS score of less than or equal to 4.0,
• access to the internet.
• the taking of immunotherapeutic agents was not relevant and not monitored

You may not qualify if:

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

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• Caritas-Krankenhaus Bad Mergentheim: collaborator

Related Publications (1)

• Tallner A, Tzschoppe R,Peters S, Mäurer M, Pfeifer K. Internetgestützte Bewegungsförderung bei Personen mit Multipler Sklerose. Neurologie und Rehabilitation 19(1): 35-46, 2013.

  BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Matthias Mäurer, Dr.

  Caritas-Krankenhaus Bad Mergentheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 13, 2016
• Study Start: February 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 24, 2016

Record last verified: 2016-06