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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Walking exercise therapy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Exercise, Walking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Aarhus University, Health, Exercise Biology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Walking exercise therapy

Control/Waitlist

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

6-minutes walk test (6MWT)
Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.

Secondary Outcome Measures

6-minutes walk test (6MWT)
Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.
Timed 25-foot walk test (T25FWT)
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).
Timed 25-foot walk test (T25FWT)
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).
Six spot step test (SSST)
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.
Six spot step test (SSST)
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.
12-item multiple sclerosis walking scale (MSWS-12)
Questionnaire (patient-reported outcome) assessing patient-reported impact of multiple sclerosis on walking ability. Total score range 12-60 (0-100%); lower is better.
12-item multiple sclerosis walking scale (MSWS-12)
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.
Modified fatigue impact scale (MFIS)
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.
Modified fatigue impact scale (MFIS)
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.
Falls-efficacy scale (FES-I)
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.
Falls-efficacy scale (FES-I)
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.
WHO five well-being index (WHO5)
Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better.
WHO five well-being index (WHO5)
Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better.
EuroQoL 5 dimensions 3 levels (EQ5D)
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.
EuroQoL 5 dimensions 3 levels (EQ5D)
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.
Baecke physical activity questionnaire
Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities. 4 questions. Score range is continuous (0-xx). Higher is better.
Baecke physical activity questionnaire
Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities. 4 questions. Score range is continuous (0-xx). Higher is better.
Patient-determined disease steps (PDDS)
Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS). 9 questions/categories. Each category represents disability level; lower is better.
Patient-determined disease steps (PDDS)
Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS). 9 questions/categories. Each category represents disability level; lower is better.

Full Information

First Posted
November 25, 2021
Last Updated
August 31, 2023
Sponsor
University of Aarhus
Collaborators
The Danish MS Society
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1. Study Identification

Unique Protocol Identification Number
NCT05415956
Brief Title
"Outwalk MS" - Benefits of Outdoor Walking in Multiple Sclerosis
Official Title
"Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish MS Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Exercise, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walking exercise therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Control/Waitlist
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise therapy
Other Intervention Name(s)
Physical exercise
Intervention Description
Moderate-to-high intensity walking exercise therapy (7 weeks, 14 session) with progression in duration and intensity.
Primary Outcome Measure Information:
Title
6-minutes walk test (6MWT)
Description
Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary Outcome Measure Information:
Title
6-minutes walk test (6MWT)
Description
Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
Timed 25-foot walk test (T25FWT)
Description
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).
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
Timed 25-foot walk test (T25FWT)
Description
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).
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
Six spot step test (SSST)
Description
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.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
Six spot step test (SSST)
Description
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.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
12-item multiple sclerosis walking scale (MSWS-12)
Description
Questionnaire (patient-reported outcome) assessing patient-reported impact of multiple sclerosis on walking ability. Total score range 12-60 (0-100%); lower is better.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
12-item multiple sclerosis walking scale (MSWS-12)
Description
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.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
Modified fatigue impact scale (MFIS)
Description
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.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
Modified fatigue impact scale (MFIS)
Description
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.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
Falls-efficacy scale (FES-I)
Description
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.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
Falls-efficacy scale (FES-I)
Description
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.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
WHO five well-being index (WHO5)
Description
Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
WHO five well-being index (WHO5)
Description
Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
EuroQoL 5 dimensions 3 levels (EQ5D)
Description
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.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
EuroQoL 5 dimensions 3 levels (EQ5D)
Description
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.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
Baecke physical activity questionnaire
Description
Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities. 4 questions. Score range is continuous (0-xx). Higher is better.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
Baecke physical activity questionnaire
Description
Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities. 4 questions. Score range is continuous (0-xx). Higher is better.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Title
Patient-determined disease steps (PDDS)
Description
Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS). 9 questions/categories. Each category represents disability level; lower is better.
Time Frame
Change from baseline (Pre) to after 7 weeks intervention (Post)
Title
Patient-determined disease steps (PDDS)
Description
Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS). 9 questions/categories. Each category represents disability level; lower is better.
Time Frame
Change from baseline (Pre) to 24 weeks follow-up (Follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars G Hvid, MSc, PhD
Organizational Affiliation
Aarhus University, Department of Public Health, Exercise Biology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University, Health, Exercise Biology
City
Aarhus
State/Province
Jutland
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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