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

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ClinicalTrials.gov Identifier: NCT05415956
Recruitment Status : Recruiting
First Posted : June 13, 2022
Last Update Posted : June 13, 2022
Sponsor:
Collaborator:
The Danish MS Society
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Walking exercise therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

7 week randomized controlled trial; intervention group and waitlist/control group.

The investigators will perform a cluster randomization (computer generated random numbers) according to cities across Denmark (when 4-12 pwMS are interested and eligible).

Waitlist/control group will be offered the same outdoor walking exercise therapy after the initial 7 weeks.

24 weeks after the walking exercise intervention, a follow-up test will be carried out as well.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Walking exercise therapy

7 week intervention group. 6-12 persons per group. 2 sessions per week, 14 sessions in total.

Surface: the investigators aim to involve as much forest/gravel trails as possible, with up/down hill walking.

Uneven session numbers: warm-up (6 minutes at BORG 10-11), continous walking (starting at 12-20 minutes at BORG 13-14 and progressing to 20-40 minutes at BORG 15-16, adjusted according to the starting level of each participant) and cool-down (approximately 10 minutes at BORG 10-11).

Even session numbers: warm-up (6 minutes at BORG 10-11), intermittent walking (starting at 3-4 intervals of 2 minutes at BORG 14-15 and progressing to 4-5 intervals of 2-3 minutes at BORG 16-17; with all intervals being interspersed by 1 minute rest) and cool-down (approximately 10 minutes at BORG 10-11).

Behavioral: Walking exercise therapy
Moderate-to-high intensity walking exercise therapy (7 weeks, 14 session) with progression in duration and intensity.
Other Name: Physical exercise

No Intervention: Control/Waitlist
7 week control/waitlist group. Continuation of habitual lifestyle during the 7 week intervention period (yet these participants will receive the exact walking exercise therapy afterwards).



Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05415956


Contacts
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Contact: Lars Hvid, MSc, PhD 93508717 ext 45 lhvid@ph.au.dk

Locations
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Denmark
Aarhus University, Health, Exercise Biology Recruiting
Aarhus, Jutland, Denmark, 8000
Contact: Ulrik Dalgas, MSc,PhD    40123039 ext 45    dalgas@ph.au.dk   
Sponsors and Collaborators
University of Aarhus
The Danish MS Society
Investigators
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Principal Investigator: Lars G Hvid, MSc, PhD Aarhus University, Department of Public Health, Exercise Biology
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT05415956    
Other Study ID Numbers: Outwalk_MS
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Exercise
Walking
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases