Trial Outcomes & Findings for Cubii for Exercise in People With MS (NCT NCT05826431)

NCT ID: NCT05826431

Last Updated: 2024-12-03

Results Overview

Average minutes participants used the device each day

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline - Week 9
• Results posted on: 2024-12-03

Participant Flow

Participant milestones

Measure	Participants Using Cubii 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. Cubii elliptical: Low impact, portable, and compact elliptical for seated use.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Participants Using Cubii 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. Cubii elliptical: Low impact, portable, and compact elliptical for seated use.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Cubii for Exercise in People With MS

Baseline characteristics by cohort

Measure	Participants Using Cubii n=20 Participants 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. Cubii elliptical: Low impact, portable, and compact elliptical for seated use.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline - Week 9

Average minutes participants used the device each day

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Average Daily Use	19.72 Minutes Standard Deviation 0.59

PRIMARY outcome

Timeframe: [Baseline, Week 9

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.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Activity - Godin Leisure Time Exercise Questionnaire Baseline	25.95 units on a scale Standard Deviation 40.73
Change in Activity - Godin Leisure Time Exercise Questionnaire Week 9	44.60 units on a scale Standard Deviation 85.76

PRIMARY outcome

Timeframe: [Baseline, Week 9

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.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a Baseline	40.49 units on a scale Standard Deviation 2.54
Change in Activity - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function 20a Week 9	41.10 units on a scale Standard Deviation 2.22

PRIMARY outcome

Timeframe: Baseline - Week 9

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

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Device Utilization Participants reporting being very satisfied or satisfied with the Cubii as an exercise device.	14 Participants
Device Utilization Participants reporting being very likely or likely to continue to use their Cubii.	18 Participants
Device Utilization Participants reporting they were likely to recommend the device to other people with MS.	17 Participants
Device Utilization Participants reporting improvement in quality of life.	14 Participants
Device Utilization Participants reporting improvement in physical function.	13 Participants
Device Utilization Participants reporting improvement in activity level.	14 Participants

SECONDARY outcome

Timeframe: [Baseline, Week 9

A structured, self-report questionnaire examining quality of life that contains 54-items, generating 12 subscales with two summary scores (physical health and mental health) and two additional single-item measures (satisfaction with sexual function and change in health). In scoring the MSQOL-54, two summary scores (physical and mental health) are produced from a weighted combination of scale scores, where scores range from 0 to 100. A higher score indicates improved quality of life.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Quality of Life - Multiple Sclerosis Quality of Life-54 (MSQOL54) Quality of Life Subscale Baseline	59.74 units on a scale Standard Deviation 13.27
Change in Quality of Life - Multiple Sclerosis Quality of Life-54 (MSQOL54) Quality of Life Subscale Week 9	63.95 units on a scale Standard Deviation 16.62

SECONDARY outcome

Timeframe: [Baseline, Week 9

Patient-reported pain intensity consisting of 3 items assessing pain intensity over the past seven days. Each item is scored 1 (no pain) to 5 (very severe pain) yielding a raw score between 3 to 15, which is converted to a standard t-score. Higher scores indicate greater self-reported intensity of pain.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Pain Intensity - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a Baseline	54.21 units on a scale Standard Deviation 9.22
Change in Pain Intensity - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 3a Week 9	53.95 units on a scale Standard Deviation 8.99

SECONDARY outcome

Timeframe: [Baseline, Week 9

A structured, self-report questionnaire consisting of 8 items measuring the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities (e.g., how much did pain interfere with your day-to-day activities). Each item is scored 1 (not at all) to 5 (very much).The total raw score is calculated by summing the individual responses. The raw score ranges from 8-40; a higher score reflects more severe depressive symptoms. The total raw score is translated into a T-score for each participant according to the PROMIS Scoring Manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale (Short Form 8b, V1.0) Baseline	54.72 units on a scale Standard Deviation 8.23
Change in Pain Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale (Short Form 8b, V1.0) Week 9	57.32 units on a scale Standard Deviation 9.82

SECONDARY outcome

Timeframe: [Baseline, Week 9]

A structured, self-report questionnaire consisting of 21 statements examining the effects of fatigue. Each statement is scored on a scale of 0-4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = almost always). The total MFIS score can range from 0-84; the higher the score, the stronger the feelings of fatigue.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Fatigue Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue-Multiple Sclerosis 8a Baseline	59.36 units on a scale Standard Deviation 6.88
Change in Fatigue Interference - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue-Multiple Sclerosis 8a Week 9	59.39 units on a scale Standard Deviation 5.83

SECONDARY outcome

Timeframe: [Baseline, Week 9

A structured, self-report questionnaire consisting of 8 items examining negative mood (sadness, guilt), view of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Respondents rate the strength of agreement with statements about depressive symptoms using a 1-5 scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always). The total raw score is calculated by summing the individual responses. The raw score ranges from 8-40; a higher score reflects more severe depressive symptoms. The total raw score is translated into a T-score for each participant according to the PROMIS Scoring Manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a Baseline	48.20 units on a scale Standard Deviation 11.04
Change in Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Depression 8a Week 9	48.15 units on a scale Standard Deviation 9.51

SECONDARY outcome

Timeframe: [Baseline, Week 9

A structured, self-report questionnaire consisting of 6 items examining anxiety symptoms in the past 7 days using a 5-point scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always). The lowest possible raw score is 6; the highest possible raw score is 30. Higher results mean greater anxiety symptoms. The total raw score is translated into a T-score for each participant according to the PROMIS Scoring Manual. The T-score provides a standardized score with a mean of 50 and a standard deviation of 10.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 8a Baseline	48.72 units on a scale Standard Deviation 10.24
Change in Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 8a Week 9	45.90 units on a scale Standard Deviation 9.40

SECONDARY outcome

Timeframe: [Baseline, Week 9

The BFI is a 9-item, 11-point rating scale developed to assess subjective fatigue. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities including general activity, mood, walking ability, normal work (both inside and outside the home), relations with other people, and enjoyment of life. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Higher scores on the BFI correspond to greater self-reported levels of fatigue. The time period for all questions is over the past 24 hours.

Outcome measures

Measure	Participants Using Cubii n=20 Participants Participants using Cubii exercise unit at their homes for two months as they choose.
Change in Fatigue Intensity - Brief Fatigue Inventory (BFI) Baseline	6.60 units on a scale Standard Deviation 2.53
Change in Fatigue Intensity - Brief Fatigue Inventory (BFI) Week 9	6.18 units on a scale Standard Deviation 2.34

Adverse Events

Participants Using Cubii

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kevin Alschuler, Director of Rehabilitation Research

UW Medicine Multiple Sclerosis Center

Phone: 206-668-8413

Email: kalschul@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place