Trial Outcomes & Findings for Spinal Cord Injury Program in Exercise (NCT NCT03925077)

Participants were recruited through social media platforms (e.g., Instagram, Facebook) and word of mouth. Recruitment for the Feasibility Phase took place between February 2021 and March 2022. Recruitment for the Effectiveness Phase occurred between August 2023 and September 2024. Recruitment and enrollment for both study phases were performed separately.

In the Feasibility Phase, the 36 enrolled participants were randomized to 3 groups: M2M, SET, and AC. For the Effectiveness Phase, the M2M arm was dropped after interim analysis and the 60 enrolled participants were randomized to 2 groups: SET and AC.

In Feasibility phase, there were three study arms (M2M, SET, and AC) with 36 participants randomized and participated. In the Effectiveness phase, the M2M arm was removed. The goal of the Effectiveness phase was to compare the effectiveness between SET and AC. We report the baseline characteristics of participants in the Effectiveness phase here.

Physical activity was assessed using the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI). The LTPAQ-SCI is a 3-item, self-report questionnaire that measures the minutes people with spinal cord injury spend in mild, moderate, and heavy intensity leisure time physical activity in the last 7 days.

The pain intensity was assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Adult Short Form 3a (v1.0). The instrument is a 3-item measure with the response scores ranging from 1 (Had no pain) to 5 (Very severe). The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis. Higher scores indicate higher pain intensity.

The influence of pain on performing daily activities was assessed with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference Adult Short Form 8a (v1.0). The form contains 8 items with 5 response options ranging from 1 (Not at all) to 5 (Very much). The form has raw scores range from 8 to 40, with higher scores indicating more pain interference. The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.

Sleep quality is assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Adult Short Form 8a, which contains 8 items on a 5-point Likert scale, ranging from 1 (Very much) to 5 (Not at all). The form has raw scores range from 8 to 40, with higher scores indicating worst sleep quality. The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.

Fatigue was measured using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue Adult Short Form. The instrument is a 8 items on a 5-point Likert scale, ranging from 1 (Not at all/Never) to 5 (Very much/Always). Higher scores indicate higher fatigue. The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.

Health-related quality of life was assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) 10 Global Health Items. The Global-10 Health form is a 10-item measure with the response scores ranging from 1 (Poor/Not at all/Always/Very severe) to 5 (Excellent/Completely/Never/None). One question item, "how would you rate your pain on average?", is on a 11-point Likert scale that ranges from 0 (No pain) to 10 (Worst pain imaginable). Higher scores indicate better health-related quality of life. The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.

Social participation was measured using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Ability to Participate in Social Roles and Activities Short Form 8a. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.each participant for analysis.