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

NCT05415956 | Completed DMC

• 1 other identifier: Outwalk_MS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Exercise; Walking

Outcome Measures

Primary Outcomes (1)

• 6-minutes walk test (6MWT)

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

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

Secondary Outcomes (19)

• 6-minutes walk test (6MWT)

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

• Timed 25-foot walk test (T25FWT)

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

• Timed 25-foot walk test (T25FWT)

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

• Six spot step test (SSST)

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

• Six spot step test (SSST)

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

Study Arms (2)

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).

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).

Interventions

Walking exercise therapy BEHAVIORAL

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

Also known as: Physical exercise

Walking exercise therapy

Eligibility Criteria

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

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish MS Society: collaborator

Study Sites (1)

Aarhus University, Health, Exercise Biology

Aarhus, Jutland, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40252300 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lars G Hvid, MSc, PhD

  Aarhus University, Department of Public Health, Exercise Biology

  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: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: June 13, 2022
• Study Start: November 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: November 30, 2022
• Last Updated: September 1, 2023

Record last verified: 2021-11

Locations

DK (1)