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Design and Delivery Preferences for Exercise Intervention in People With Spinal Cord Injury

Design and Delivery Preferences for Exercise Intervention in People With Spinal Cord Injury: a Pilot Discrete Choice Experiment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06578780
Enrollment
110
Registered
2024-08-29
Start date
2024-08-27
Completion date
2026-05-31
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injury, Exercise, Adults

Brief summary

This research study aims to explore people's understanding of physical activity behavior and perceptions of what a physical activity program should include for supporting initiation and continuous participation. This study will enroll up to 30 adults (18 or over) with spinal cord injury. The study will use a discrete choice experiment (DCE) design that implements both quantitative (development of preference survey) and qualitative approaches (systematic review; test of preference survey).

Detailed description

Aim 1. To explore individual preferences and needs that are related to engaging in a physical activity behavior using both qualitative and quantitative approaches. The identification of attributes will be achieved through (a) qualitative interviews of 30 adults living with SCI, (b) expert opinion of 10 healthcare professionals who have at least 5 years of work experience with SCI patients and in the field of SCI research, and (c) a rapid review of literature reporting on preferred design, equipment, and/or delivery methods for physical activity/exercise programs for people with SCI. For the qualitative approach, we will use semi-structured, one-on-one interviews. Using deductive content analysis, we will generate participant-informed categories that aligned with the "what, when, where, and who" of exercise programs for people with SCI to develop an initial DCE survey. Participants who take part in this study will engage in two one-on-one interviews that last approximately 1 hour each, depending on how much information is shared with the researcher. The interview will be conducted by the lead researcher via phone or video conference call. The interview will be audio-recorded, which will later be transcribed. The interview will ask questions about your interests, preferences, and wants for a physical activity program that supports initiation and long-term participation. The information shared during the interview will be used to create a preference survey, and the interviewed participants will be contacted again to complete the developed survey and a second interview to see whether the survey fully covered the choices of their needs and wants. Aim 2. To develop and refine a quantitative DCE survey that contains essential attributes and preference levels for physical activity participation. The developed initial DCE from Aim 1 will be further refined through the survey responses and feedback from the interviewed participants with SCI as well as iterative discussions with the interviewed healthcare professionals. The evaluation criteria will follow the DCE design guidelines, such as the clarity of the attributes, attribute descriptions, and preference levels; redundancy of attributes and levels defined; and level of burden. Aim 3. 3-1. To examine which attributes and preference levels are essential and more likely to be accepted for increasing participation in a physical activity intervention. The developed and refined DCE from Aim 1 and 2 will be pilot tested among 100 people with SCI, who were not involved in the qualitative interview and survey refinement processes. Using conjoint analysis techniques, we will develop prediction models based on the possible combinations of attributes and levels (e.g., 24 combinations = 3 levels of "what" x 2 of "when" x 2 of "where" x 2 of "who"). 3-2. To examine whether these preferences vary by participants' personal and clinical characteristics, such as age, functional level, residential area (urban vs. rural), and self-reported physical activity and motivational readiness to physical activity behavior change (pre-intenders, intenders, actors). Hypothesis: Adults with SCI who are currently meeting/exceeding physical activity guidelines (actors) will choose a self-guided physical activity program over a supervised, instructor-led program. Adults with SCI who have a high level of self-regulatory skills (goal setting and planning) will choose a self-guided physical activity program over a supervised, instructor-led program.

Interventions

None listed

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
The Craig H. Neilsen Foundation
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults (≥18 years) with spinal cord injury * able to converse and read in English

Exclusion criteria

* presence of cognitive impairment that prevents adhering to the study protocol

Design outcomes

Primary

MeasureTime frameDescription
Demographics & clinical informationBaseline, during the first interviewage, ethnicity, race, date of spinal cord injury onset, injury level, injury type
Physical activityBaseline, during the first interviewComplete LTPAQ-SCI online survey (mins of physical activity per week)
Preference survey3-month follow-up, before the second interviewDeveloped preference survey based on the first interview

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORYumi Kim, PhD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026