Multiple SclerosisNCT05415956
"Outwalk MS" - Benefits of Outdoor Walking in Multiple Sclerosis
A study testing Walking exercise therapy in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Walking exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Health, Exercise Biology
Aarhus, Jutland, 8000
About this study
Official title: "Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Walking exercise therapy
- Keywords
- Exercise, Walking
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exercise therapyBehavioural
Also called Physical exercise
Moderate-to-high intensity walking exercise therapy (7 weeks, 14 session) with progression in duration and intensity.
| Study group | Role | What they receive |
|---|---|---|
| Walking exercise therapy | Experimental | 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). Receives: Behavioral: Walking exercise therapy |
| Control/Waitlist | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minutes walk test (6MWT)
Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary outcomes (19)
6-minutes walk test (6MWT)
Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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).
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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).
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
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.
Measured: Change from baseline (Pre) to after 7 weeks intervention (Post)
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.
Measured: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Nov 2021
- Primary completion31 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish MS Society
- Responsible party
- Sponsor
- Investigators
- Lars G Hvid, MSc, PhD, Principal investigator, Aarhus University, Department of Public Health, Exercise Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415956
- Sponsor's protocol ID
- Outwalk_MS
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hvid LG, Steenberg JL, Roy F, Skovgaard L. Outdoor walking exercise therapy improves walking capacity and well-being in persons with multiple sclerosis: A randomized controlled trial. Ann Phys Rehabil Med. 2025 Sep;68(6):101985. doi: 10.1016/j.rehab.2025.101985. Epub 2025 Apr 18.
PubMed 40252300
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05415956
- Acronym / sponsor ID
- Outwalk_MS
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish MS Society
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Walking exercise therapy | Experimental | Behavioral: Walking exercise therapy7 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). |
| Control/Waitlist | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking exercise therapyAlso: Physical exerciseModerate-to-high intensity walking exercise therapy (7 weeks, 14 session) with progression in duration and intensity. | Behavioural | Walking exercise therapy |
Primary outcome
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.
19 secondary outcomes
6-minutes walk test (6MWT)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Timed 25-foot walk test (T25FWT)
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
Timed 25-foot walk test (T25FWT)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Six spot step test (SSST)
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
Six spot step test (SSST)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
12-item multiple sclerosis walking scale (MSWS-12)
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
12-item multiple sclerosis walking scale (MSWS-12)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Modified fatigue impact scale (MFIS)
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
Modified fatigue impact scale (MFIS)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Falls-efficacy scale (FES-I)
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
Falls-efficacy scale (FES-I)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
WHO five well-being index (WHO5)
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
WHO five well-being index (WHO5)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
EuroQoL 5 dimensions 3 levels (EQ5D)
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
EuroQoL 5 dimensions 3 levels (EQ5D)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Baecke physical activity questionnaire
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
Baecke physical activity questionnaire
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Patient-determined disease steps (PDDS)
Time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)
Patient-determined disease steps (PDDS)
Time frame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 40252300Hvid LG, Steenberg JL, Roy F, Skovgaard L. Outdoor walking exercise therapy improves walking capacity and well-being in persons with multiple sclerosis: A randomized controlled trial. Ann Phys Rehabil Med. 2025 Sep;68(6):101985. doi: 10.1016/j.rehab.2025.101985. Epub 2025 Apr 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars G Hvid, MSc, PhD principal investigator
Aarhus University, Department of Public Health, Exercise Biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking exercise therapy in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minutes walk test (6MWT) (time frame: Change from baseline (Pre) to after 7 weeks intervention (Post)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.