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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05415956
Other study ID # Outwalk_MS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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