Cubii for Exercise in People With MS

NCT05826431 | Completed Results FDA Device

• 1 other identifier: STUDY00016696
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this observational study are to evaluate (1) the feasibility, usability, and satisfaction with the Cubii elliptical and (2) the preliminary efficacy of the Cubii elliptical for increasing activity (primary outcome), physical function, and quality of life, and decreasing physical and psychological symptom (e.g., pain, fatigue, depression) severity in people with MS. The main question it aims to answer is how usable and feasible is the Cubii as a mode of exercise for people with MS? Participants will use the Cubii as they choose and keep a written log of this use. They will answer questions about their demographics, MS disease-related variables (e.g., pain, fatigue, falls), activity, exercise, quality of life, and biopsychosocial symptom variables) and provide additional data regarding the feasibility, usability, and satisfaction with use of the Cubii.

Conditions

Multiple Sclerosis; Fatigue; Activity, Motor; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Average Daily Use

  Average minutes participants used the device each day

  Baseline - Week 9

• Change in Activity - Godin Leisure Time Exercise Questionnaire

  The Godin Leisure-Time Exercise Questionnaire (GLTEQ; Godin \& Shephard, 1985) is a 4-item self-administered questionnaire seeking information re: the number of times one engages in mild, moderate and strenuous leisure-time physical activity bouts of at least 15 min duration in a typical week. The GLTEQ was used to assess the frequency of typical weekly strenuous, moderate, and mild exercise. Total exercise scores were also computed by multiplying each reported exercise frequency by its metabolic equivalent (MET) and then summing the totals: (strenuous x 9) + (moderate x 5) + (mild x 2) (Godin, Jobin, \& Boullon, 1986). Higher scores indicate greater exercise engagement.

  [Baseline, Week 9

• Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a

  The tool asks participants to rate the difficulty in performing twenty common activities of daily living using scale that ranges from 1-5, where 1=unable to do and 5=without any difficulty. The total raw score is calculated by summing the individual responses. A higher score indicates higher function.

  [Baseline, Week 9

• Device Utilization

  Qualitative findings: a narrative summary of participant responses to interview questions about using the device.

  Baseline - Week 9

Secondary Outcomes (7)

• Change in Quality of Life - Multiple Sclerosis Quality of Life-54 (MSQOL54) Quality of Life Subscale

  [Baseline, Week 9

• Change in Pain Intensity - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a

  [Baseline, Week 9

• Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale (Short Form 8b, V1.0)

  [Baseline, Week 9

• Change in Fatigue Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue-Multiple Sclerosis 8a

  [Baseline, Week 9]

• Change in Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a

  [Baseline, Week 9

Study Arms (1)

Participants using Cubii

EXPERIMENTAL

Participants will use the Cubii exercise unit at their homes for two months as they choose. They will maintain a log regarding their use of the device. They will complete validated self-report questionnaires (demographics, MS disease-related variables (e.g., pain, fatigue, falls), activity, exercise, quality of life, and biopsychosocial symptom variables) before and after the use of the exercise unit.

Device: Cubii elliptical

Interventions

Cubii elliptical DEVICE

Low impact, portable, and compact elliptical for seated use.

Participants using Cubii

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinician-confirmed MS
• years of age or older
• Walks with the aid of an assistive device (e.g., cane, walker, forearm crutches)
• Able to read and speak English
• Lives in the greater Seattle metropolitan area
• All genders
• Has an iPhone or Android phone that can download apps

You may not qualify if:

• \- People unable to exercise for health reasons

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

UW Medicine

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

This study had limitations. As a proof-of-concept study there was no comparison group, such as a wait-list control group. While appropriate for this stage of research, the sample size was small and not generalizable. Additionally, the study timeframe was relatively short at 8 weeks; future studies would benefit from a longer follow up to assess whether use is sustained over time.

Results Point of Contact

• Title: Dr. Kevin Alschuler, Director of Rehabilitation Research
• Organization: UW Medicine Multiple Sclerosis Center

kalschul@uw.edu

206-668-8413

Study Officials

• Kevin Alschuler, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Rehabilitation Medicine

Model Details: Participants will use the equipment for two months as they choose, keep a log of their use, and answer pre- and post- participation questionnaires.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 24, 2023
• Study Start: April 19, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 4, 2023
• Last Updated: December 3, 2024
• Results First Posted: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)