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Continued M2M + SNS for 9 weeks for Spinal Cord Injury (SMART-HEALTH Trial)

N/A

Waitlist Available

Led By Jereme D Wilroy, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4-weeks, 8-weeks, and 12 weeks

Awards & highlights

SMART-HEALTH Trial Summary

This trial is testing the feasibility and acceptability of an at-home exercise intervention for seniors. They will assess how well the intervention is delivered and how acceptable it is to participants, as well as estimating effect sizes for a future trial.

SMART-HEALTH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4-weeks, 8-weeks, and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4-weeks, 8-weeks, and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-weeks, 8-weeks, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Physical Activity

Secondary outcome measures

Anxiety

Blood pressure

Depression

+8 more

SMART-HEALTH Trial Design

6Treatment groups

Active Control

Group I: Continued M2M + SNS for 9 weeksActive Control1 Intervention

Participants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 9 weeks of the study.

Group II: Augmented M2M + SNS + IBC for 9 weeksActive Control1 Intervention

Some participants with sub-optimal adherence in the first treatment stage will be randomized to one of two treatment groups in the second treatment stage. these participants will receive M2M plus social networking support augmented with individualized behavioral coaching. Individualized behavioral coaching involves a weekly coaching session to improve self-regulatory skills based on prior and individualized exercise prescription. The exercise prescriptions are determined by the coach and individual based on their current activity level and a 4-week goal. An example of tailoring the exercise prescribed involves setting a goal of completing the exercise routine one time for the upcoming week instead of three times. The coach will be trained in motivational interviewing to help the participant modify their exercise habits.

Group III: Switched M2M Live for 9 weeksActive Control1 Intervention

The remaining half of participants with sub-optimal adherence in the first treatment stage will switch to another M2M-based home exercise intervention, M2M Live. M2M Live involves one-on-one tele-exercise training with an M2M instructor, which provides accountability and immediate, tailored feedback along with custom movements and music. During the first week of M2M Live, the participant will set a schedule to meet with the M2M instructor 1 time each week for an exercise session. The M2M Live instructors are also trained in motivational interviewing in order to coach participants through any barriers to changing their exercise behavior.

Group IV: Continued M2M + IBC for 6 weeksActive Control1 Intervention

Participants who successfully watch and exercise at or above 40 minutes per week will continue doing M2M + SNS for the remaining 6 weeks of the study.

Group V: Augmented M2M + SNS + IBC for 6 weeksActive Control1 Intervention

Group VI: Switched M2M Live for 6 weeksActive Control1 Intervention

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Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,277,993 Total Patients Enrolled

The Craig H. Neilsen FoundationOTHER

54 Previous Clinical Trials

2,859 Total Patients Enrolled

Lakeshore FoundationOTHER

9 Previous Clinical Trials

1,837 Total Patients Enrolled

Media Library

Movement-2-Music + Social Networking Support Clinical Trial Eligibility Overview. Trial Name: NCT04726891 — N/A

Spinal Cord Injury Research Study Groups: Continued M2M + SNS for 9 weeks, Augmented M2M + SNS + IBC for 9 weeks, Switched M2M Live for 9 weeks, Continued M2M + IBC for 6 weeks, Augmented M2M + SNS + IBC for 6 weeks, Switched M2M Live for 6 weeks

Spinal Cord Injury Clinical Trial 2023: Movement-2-Music + Social Networking Support Highlights & Side Effects. Trial Name: NCT04726891 — N/A

Movement-2-Music + Social Networking Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT04726891 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this research extend past seventy years old?

"The age limit for this study is 71 years old, and all potential participants must be over the age of 18."

Answered by AI

Are we able to sign up new participants for the trial at this time?

"That is correct. The online clinicaltrial.gov registry reveals that this study is still recruiting patients. The first posting was on June 26th, 2022, with the most recent update occurring on June 29th, 2022. Currently, the study is looking for 44 individuals at a single site."

Answered by AI

How many people are authorized to be enrolled in this experiment?

"Yes, that is correct. The listing on clinicaltrials.gov affirms that recruitment is still open for this trial. The trial was first posted on 6/26/2022 and was last updated on 6/29/2022. The goal is to recruit 44 patients from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of the First Known Adaptive Intervention for People With SCI

Jereme Wilroy 2022. "Feasibility of the First Known Adaptive Intervention for People With SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04726891.