The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Frame Running
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- People with a definite diagnosis of MS according to the revised MacDonald criteria, aged 18 and over, experiencing walking or balance difficulties but able to transfer independently will be eligible to take part in this study. This equates to people with an EDSS of 3.5 to 7. In order to be eligible for taking part in the Frame Running sessions, people should also be able comprehend and follow instructions relating to participation training as well as have sufficient understanding of the English language to complete the consent forms and questionnaires
Exclusion Criteria:
- Those with contraindications to exercise, those unable to safely propel the frame for any distance on their own using the try-out sessions and those with more than 10 hours of FR experience will be excluded from participation in this study. Other exclusion criteria are lower limb surgery less than 3 months prior to the start of the study, having started disease modifying and/or spasticity treatment less than 3 months prior to the start of the study and severe visual impairment affecting the ability to safely take part in Frame Running training sessions.
Sites / Locations
- Queen Margaret UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Frame Running intervention
Arm Description
Participants will be invited to 12 Frame Running training sessions
Outcomes
Primary Outcome Measures
Exercise Self Efficacy Scale
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Exercise Self Efficacy Scale
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Psychological Impact of Assistive Devices Scale
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Psychological Impact of Assistive Devices Scale
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Five times sit-to-stand test
measurer of functional strength, Duration, measured in seconds
Five times sit-to-stand test
measurer of functional strength, Duration, measured in seconds
Canadian Occupational Performance Measure
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Canadian Occupational Performance Measure
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Resting blood pressure
resting blood pressure in mmHg
Resting blood pressure
resting blood pressure in mmHg
six minute Frame Running test
measured in meters travelled during 6 minutes, test conducted on a running track
six minute Frame Running test
measured in meters travelled during 6 minutes, test conducted on a running track
Frame Running shuttle run/walk test
test conducting on the running track, outcome is number of shuttles performed
Frame Running shuttle run/walk test
test conducting on the running track, outcome is number of shuttles performed
weekly step count
Measured using an ActivPAL activity monitor
weekly step count
Measured using an ActivPAL activity monitor
Fatigue Scale for Motor and Cognitive Functions (FSMC)
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Fatigue Scale for Motor and Cognitive Functions (FSMC)
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Multiple Sclerosis Walking Scale
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Multiple Sclerosis Walking Scale
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Godin Leisure time exercise questionnaire
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Godin Leisure time exercise questionnaire
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Secondary Outcome Measures
number of weekly training session attended
range 0 to 12
Heart rate during the training session
maximum HR and time spent in HR zones
Heart rate during the training session
maximum HR and time spent in HR zones
Full Information
NCT ID
NCT05234879
First Posted
January 20, 2022
Last Updated
April 3, 2023
Sponsor
Queen Margaret University
Collaborators
Multiple Sclerosis Society of Great Britain
1. Study Identification
Unique Protocol Identification Number
NCT05234879
Brief Title
The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis
Official Title
The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis With Impaired Balance and Mobility
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Margaret University
Collaborators
Multiple Sclerosis Society of Great Britain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is ample evidence that regular exercise can reduce MS specific symptoms and improve health and wellbeing in people with MS. However, for people with MS to engage in exercise activities long term, it is important that they are offered a range of exercise opportunities that are safe, feasible and potentially effective to reduce MS symptom. This will allow people to select an activity they enjoy, is adapted to their needs and thus are more sustainable long-term. Frame Running (FR) provides an opportunity for people with walking and balance problems to walk or run safely without the risk of falling. The frame consists of three wheels and has a saddle and handlebars like a trike without pedals. The proposed mixed methods study aims to examine the feasibility and acceptability of FR as a sustainable aerobic exercise option for people with MS and the feasibility of conducting a future definite trial into the impact of FR on functional mobility, fatigue, cardiorespiratory function and psychosocial outcomes. People who experience problems with their walking and/or balance will be eligible to take part in this study which consists of a 12 weekly group FR training sessions led by a qualified coach. FR training attendance, recruitment, retention, outcome measure completion and adverse events will be recorded and the participant views on the feasibility, acceptability and impact of FR will be explored through the use of focus groups. Physical function, physical activity and psychosocial outcomes will be assessed at baseline, 6 and 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Frame Running intervention
Arm Type
Experimental
Arm Description
Participants will be invited to 12 Frame Running training sessions
Intervention Type
Other
Intervention Name(s)
Frame Running
Intervention Description
Frame Running (FR) provides an opportunity for people with walking and balance problems to walk or run safely without the risk of falling. The frame consists of three wheels and has a saddle and handlebars like a trike without pedals.
Primary Outcome Measure Information:
Title
Exercise Self Efficacy Scale
Description
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Time Frame
baseline
Title
Exercise Self Efficacy Scale
Description
questionnaire (range 10-40) higher scores indicate higher self-efficacy
Time Frame
12 weeks
Title
Psychological Impact of Assistive Devices Scale
Description
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Time Frame
baseline
Title
Psychological Impact of Assistive Devices Scale
Description
questionnaire (range -3 to 3) higher score indicate improvement in psychosocial impact
Time Frame
12 weeks
Title
Five times sit-to-stand test
Description
measurer of functional strength, Duration, measured in seconds
Time Frame
baseline
Title
Five times sit-to-stand test
Description
measurer of functional strength, Duration, measured in seconds
Time Frame
12 weeks
Title
Canadian Occupational Performance Measure
Description
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Time Frame
baseline
Title
Canadian Occupational Performance Measure
Description
semi-structured interview (ratings range from 1 to 10, higher scores indicate higher perceived improvement in function
Time Frame
12 weeks
Title
Resting blood pressure
Description
resting blood pressure in mmHg
Time Frame
baseline
Title
Resting blood pressure
Description
resting blood pressure in mmHg
Time Frame
12 weeks
Title
six minute Frame Running test
Description
measured in meters travelled during 6 minutes, test conducted on a running track
Time Frame
baseline
Title
six minute Frame Running test
Description
measured in meters travelled during 6 minutes, test conducted on a running track
Time Frame
11 weeks
Title
Frame Running shuttle run/walk test
Description
test conducting on the running track, outcome is number of shuttles performed
Time Frame
baseline
Title
Frame Running shuttle run/walk test
Description
test conducting on the running track, outcome is number of shuttles performed
Time Frame
12 weeks
Title
weekly step count
Description
Measured using an ActivPAL activity monitor
Time Frame
baseline
Title
weekly step count
Description
Measured using an ActivPAL activity monitor
Time Frame
11 weeks
Title
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Description
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Time Frame
baseline
Title
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Description
questionnaire (range 20 to 100) higher scores indicate higher self-reported fatigue
Time Frame
12 weeks
Title
Multiple Sclerosis Walking Scale
Description
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Time Frame
baseline
Title
Multiple Sclerosis Walking Scale
Description
questionnaire (range 12-60) higher scores indicate higher self-reported limitation in walking ability
Time Frame
12 weeks
Title
Godin Leisure time exercise questionnaire
Description
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Time Frame
baseline
Title
Godin Leisure time exercise questionnaire
Description
questionnaire (range 0-119) higher scores indicate higher level of leisure time exercise participation
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
number of weekly training session attended
Description
range 0 to 12
Time Frame
12 weeks
Title
Heart rate during the training session
Description
maximum HR and time spent in HR zones
Time Frame
3 weeks
Title
Heart rate during the training session
Description
maximum HR and time spent in HR zones
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
focus groups
Description
insights into participant's views on positive and negative experiences or impacts and thoughts on ongoing participation
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People with a definite diagnosis of MS according to the revised MacDonald criteria, aged 18 and over, experiencing walking or balance difficulties but able to transfer independently will be eligible to take part in this study. This equates to people with an EDSS of 3.5 to 7. In order to be eligible for taking part in the Frame Running sessions, people should also be able comprehend and follow instructions relating to participation training as well as have sufficient understanding of the English language to complete the consent forms and questionnaires
Exclusion Criteria:
Those with contraindications to exercise, those unable to safely propel the frame for any distance on their own using the try-out sessions and those with more than 10 hours of FR experience will be excluded from participation in this study. Other exclusion criteria are lower limb surgery less than 3 months prior to the start of the study, having started disease modifying and/or spasticity treatment less than 3 months prior to the start of the study and severe visual impairment affecting the ability to safely take part in Frame Running training sessions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marietta L van der Linden, PhD
Phone
+44 131 470000
Email
mvanderlinden@qmu.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Pelly Koufaki, PhD
Phone
+44 131 470000
Email
pkoufaki@qmu.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marietta L van der Linden, PhD
Organizational Affiliation
Queen Margaret University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Margaret University
City
Musselburgh
State/Province
East Lothian
ZIP/Postal Code
EH21 6UU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marietta L van der Linden, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
overall study outcomes will be shared
IPD Sharing Time Frame
The data will be available as part of a publication which expected to be 31/12/2023 the latest
Learn more about this trial
The Feasibility of Frame Running as an Exercise Option for People With Multiple Sclerosis
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