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Completed

NCT Number: NCT05415956

"Outwalk MS" - Benefits of Outdoor Walking in Multiple Sclerosis

Deterioration of walking capacity is a common symptom in persons with multiple sclerosis (pwMS), furthermore having a negative influence on well-being. Studies have nevertheless shown that walking exercise therapy can improve walking capacity in pwMS. This may be particularly potent if occurring outdoors due to the varying stimuli it can provide (different surfaces and terrain etc.), and if the intensity and duration is adequate. Furthermore, outdoor walking is (1) suitable as a group intervention facilitating interaction between pwMS and (2) advantageous due to the health benefits offered through the interaction with nature itself. Both these aspects are also relevant for well-being.

Few studies have nevertheless examined the effects of outdoor walking exercise therapy in pwMS. The purpose of the present study is therefore to examine the effects of 7 weeks of moderate-to-high intensity outdoor walking exercise therapy on walking capacity (primary outcome: 6-minute walk test) and well-being in pwMS.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Health, Exercise Biology

Aarhus, Jutland, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • self-reported clinical MS diagnosis
  • PDDS ≤ 4 (corresponding to preserved walking capacity without assistive devices of at least 10 m)
  • able to independently attend the testing

Exclusion criteria

  • self-reported comorbidities excluding participation in the intervention
  • recent (6 months retrospective) fractures, amputation or other critical physical impairments that eliminates participation in the described training study
  • participation in structured exercise therapy (including walking) for the past 3 months (≥ 2 session per week of moderate-to-high intensity)

Treatment and study plan

Walking exercise therapy

Behavioral

Moderate-to-high intensity walking exercise therapy (7 weeks, 14 session) with progression in duration and intensity.

Other names: Physical exercise

Primary outcomes

  1. 6-minutes walk test (6MWT)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.

Secondary outcomes

  1. 6-minutes walk test (6MWT)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.

  2. Timed 25-foot walk test (T25FWT)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Time used to complete a 25-foot (= 7.62 meters) walk test. Two trials are given. Assesses horizontal walking propulsion/acceleration (i.e. walking speed).

  3. Timed 25-foot walk test (T25FWT)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Time used to complete a 25-foot (= 7.62 meters) walk test. Two trials are given. Assesses horizontal walking propulsion/acceleration (i.e. walking speed).

  4. Six spot step test (SSST)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Time used to complete the SSST (5 wooden blocks must be pushed/kicked outside their initial position). Four trials are given, two with each foot being used to push/kick the wooden blocks. Assesses horizontal coordination and dynamic balance during walking.

  5. Six spot step test (SSST)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Time used to complete the SSST (5 wooden blocks must be pushed/kicked outside their initial position). Four trials are given, two with each foot being used to push/kick the wooden blocks. Assesses horizontal coordination and dynamic balance during walking.

  6. 12-item multiple sclerosis walking scale (MSWS-12)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Questionnaire (patient-reported outcome) assessing patient-reported impact of multiple sclerosis on walking ability.

    Total score range 12-60 (0-100%); lower is better.

  7. 12-item multiple sclerosis walking scale (MSWS-12)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Questionnaire (patient-reported outcome) assessing patient-reported impact of multiple sclerosis on walking ability. 12 questions.

    Total score range 12-60 (0-100%); lower is better.

  8. Modified fatigue impact scale (MFIS)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Questionnaire (patient-reported outcome) assessing patient-reported perceived fatigue impact. 21 questions.

    Total score range 0-84; lower is better. Physical subscale score range (9 questions) 0-36; lower is better. Cognitive subscale score range (10 questions) 0-40; lower is better. Psychosocial subscale score range (2 questions) 0-8; lower is better.

  9. Modified fatigue impact scale (MFIS)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Questionnaire (patient-reported outcome) assessing patient-reported perceived fatigue impact. 21 questions.

    Total score range 0-84; lower is better. Physical subscale score range (9 questions) 0-36; lower is better. Cognitive subscale score range (10 questions) 0-40; lower is better. Psychosocial subscale score range (2 questions) 0-8; lower is better.

  10. Falls-efficacy scale (FES-I)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Questionnaire (patient-reported outcome) assessing concerns of falling along with history of falls.

    7 questions. Total score range 0-28; lower is better. History of falls: one year recall.

  11. Falls-efficacy scale (FES-I)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Questionnaire (patient-reported outcome) assessing concerns of falling along with history of falls.

    7 questions. Total score range 0-28; lower is better. History of falls: one year recall.

  12. WHO five well-being index (WHO5)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better.

  13. WHO five well-being index (WHO5)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better.

  14. EuroQoL 5 dimensions 3 levels (EQ5D)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Questionnaire (patient-reported outcome) assessing patient-reported quality of life.

    VAS scale score range 0-100%; higher is better. 5 domains, scored separately, score range 1-3; lower is better.

  15. EuroQoL 5 dimensions 3 levels (EQ5D)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Questionnaire (patient-reported outcome) assessing patient-reported quality of life.

    VAS scale score range 0-100%; higher is better. 5 domains, scored separately, score range 1-3; lower is better.

  16. Baecke physical activity questionnaire

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities.

    4 questions. Score range is continuous (0-xx). Higher is better.

  17. Baecke physical activity questionnaire

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities.

    4 questions. Score range is continuous (0-xx). Higher is better.

  18. Patient-determined disease steps (PDDS)

    Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

    Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS).

    9 questions/categories. Each category represents disability level; lower is better.

  19. Patient-determined disease steps (PDDS)

    Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

    Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS).

    9 questions/categories. Each category represents disability level; lower is better.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The Danish MS Society

Registry information

Official study title

"Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2022
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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