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

NCT ID: NCT05415956

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Walking exercise therapy

Intervention Type BEHAVIORAL

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

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Walking exercise therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Physical exercise

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Danish MS Society

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars G Hvid, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Department of Public Health, Exercise Biology

Locations

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Aarhus University, Health, Exercise Biology

Aarhus, Jutland, Denmark

Site Status

Countries

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Denmark

References

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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 Apr 18;68(6):101985. doi: 10.1016/j.rehab.2025.101985. Online ahead of print.

Reference Type DERIVED
PMID: 40252300 (View on PubMed)

Other Identifiers

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Outwalk_MS

Identifier Type: -

Identifier Source: org_study_id

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