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

Multiple Sclerosis Clinical Trial

Official title:

"Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05415956
• Other study ID #: Outwalk_MS
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University, Health, Exercise Biology	Aarhus	Jutland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish MS Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6-minutes walk test (6MWT)	Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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).	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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).	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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.	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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.	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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.	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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.	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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.	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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.	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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.	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Secondary	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.	Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary	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.	Change from baseline (Pre) to 24 weeks follow-up (Follow-up)