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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Walking exercise therapy

• Registration Number: NCT05415956
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-01
• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-13
• Primary Completion: 2022-07-31
• Study Completion: 2022-11-30
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking exercise therapy	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).

Primary Outcome Measures

Name	Time	Method
6-minutes walk test (6MWT)	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

Name	Time	Method
Patient-determined disease steps (PDDS)	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.
6-minutes walk test (6MWT)	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.
Timed 25-foot walk test (T25FWT)	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).
Six spot step test (SSST)	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.
12-item multiple sclerosis walking scale (MSWS-12)	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.
WHO five well-being index (WHO5)	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.
EuroQoL 5 dimensions 3 levels (EQ5D)	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.
Modified fatigue impact scale (MFIS)	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.
Falls-efficacy scale (FES-I)	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.
Baecke physical activity questionnaire	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.

Trial Locations

Locations (1)

Aarhus University, Health, Exercise Biology; 🇩🇰 Aarhus, Jutland, Denmark