Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-29 @ 6:14 PM
Study NCT ID:
NCT02225028
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2014-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Telephone Counseling to Increase Physical Fitness in SCI
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Feasibility of Telephone Counseling to Increase Physical Fitness in SCI (Co-Motion Study)
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with spinal cord injuries (SCI) are among the least physically active groups in our society. Approximately 1 in 4 healthy young persons with spinal cord injury (SCI) does not have sufficient fitness to perform many essential activities of daily living. About 50% of people with SCI engage in no leisure time physical activity. That is, they do not wheel or walk for pleasure, don't play a sport, don't exercise at home or go to a gym. As a result of this, cardiovascular, endocrine and metabolic conditions adversely affect the health of a large segment of the SCI population. Fortunately, clinic and/or laboratory-based aerobic conditioning and circuit training studies provide compelling evidence that people with SCI can improve their cardiorespiratory fitness and by doing so can partially reverse cardiovascular disease (CVD) risk factors, enhance Quality of Life (QOL) and improve elements of subjective well-being. While intensive, clinic-based, supervised exercise programs can improve the fitness and health of persons with SCI, the value of these findings for the SCI population is limited because the vast majority of people do not have access to these specialized programs and facilities. The gap that the present study addresses is: How can we extend the benefits of increased exercise and physical activity to more people with SCI?
The goal of this study is to evaluate the feasibility of an individually tailored, home- or community-based, telephone delivered intervention that uses evidence-based behavioral and motivational counseling to increase daily physical activity and exercise.
The goal of this study is to evaluate the feasibility of an individually tailored, home- or community-based, telephone delivered intervention that uses evidence-based behavioral and motivational counseling to increase daily physical activity and exercise.
Detailed Description:
The study is a randomized controlled trial comparing a 16 session telephone intervention aiming to increase physical activity to usual care.
Participants who agree to join the study and meet all eligibility criteria will be asked to do for following things in the course of 6 months.
BASELINE ASSESSMENT (Part 1 and 2):
For all participants who meet all screening eligibility criteria, a two-part baseline assessment will be scheduled at the University of Washington Medical Center Clinical Research Center.
During Part 1 of this visit, participants will complete an interview, medical tests and receive a DXA scan. After completing Part 1 of the baseline, participants will be given an activity monitor to wear at home for up to one week.
Approximately seven days after completing Part 1 of the baseline, participants will complete Part 2. Part 2 consists of a cardiorespiratory fitness test. A healthcare monitor will be available throughout testing to help ensure safety.
POST BASELINE FOLLOW-UP:
There are 3 possible outcomes following the baseline assessment.
1. Individuals may not be eligible for the study because of a medical condition that needs treatment (for example, diabetes or hypertension).
Individuals who qualify for the study will be randomized (like flipping a coin) to either a usual care group or the physical activity intervention group. Participants have an equal chance of ending up in either group.
2. Participants may be randomized into the usual care group and receive no physical activity coaching by telephone.
3. Participants may be randomized into the physical activity coaching intervention group. The physical activity coach will contact participants within one week to begin the 6 month intervention.
2 AND 4 MONTH ASSESSMENT (10 minutes):
All participants, regardless of group assignment, will be asked to complete telephone interviews with the research team two and four months after completing the baseline. Interviews will consist of questions regarding physical activity levels and barriers related to exercise.
6-MONTH OUTCOME ASSESSMENT (Part 1 and 2):
After six months, all participants will be asked to return to the University of Washington Medical Center Clinical Research Center to complete the 6-month outcome assessment. The 6-month outcome assessment will be identical to the baseline assessment.
During Part 1 of this visit, participants will complete an interview, medical tests and a DXA scan. After completing Part 1 of the 6-month outcome assessment, participants will be given an activity monitor to wear at home for up to one week.
Approximately seven days after completing Part 1 of the 6-month outcome assessment, participants will complete Part 2. During Part 2 of the visit, participants will undergo a cardiorespiratory fitness test. A healthcare monitor will be available throughout testing to help ensure safety.
Participants who agree to join the study and meet all eligibility criteria will be asked to do for following things in the course of 6 months.
BASELINE ASSESSMENT (Part 1 and 2):
For all participants who meet all screening eligibility criteria, a two-part baseline assessment will be scheduled at the University of Washington Medical Center Clinical Research Center.
During Part 1 of this visit, participants will complete an interview, medical tests and receive a DXA scan. After completing Part 1 of the baseline, participants will be given an activity monitor to wear at home for up to one week.
Approximately seven days after completing Part 1 of the baseline, participants will complete Part 2. Part 2 consists of a cardiorespiratory fitness test. A healthcare monitor will be available throughout testing to help ensure safety.
POST BASELINE FOLLOW-UP:
There are 3 possible outcomes following the baseline assessment.
1. Individuals may not be eligible for the study because of a medical condition that needs treatment (for example, diabetes or hypertension).
Individuals who qualify for the study will be randomized (like flipping a coin) to either a usual care group or the physical activity intervention group. Participants have an equal chance of ending up in either group.
2. Participants may be randomized into the usual care group and receive no physical activity coaching by telephone.
3. Participants may be randomized into the physical activity coaching intervention group. The physical activity coach will contact participants within one week to begin the 6 month intervention.
2 AND 4 MONTH ASSESSMENT (10 minutes):
All participants, regardless of group assignment, will be asked to complete telephone interviews with the research team two and four months after completing the baseline. Interviews will consist of questions regarding physical activity levels and barriers related to exercise.
6-MONTH OUTCOME ASSESSMENT (Part 1 and 2):
After six months, all participants will be asked to return to the University of Washington Medical Center Clinical Research Center to complete the 6-month outcome assessment. The 6-month outcome assessment will be identical to the baseline assessment.
During Part 1 of this visit, participants will complete an interview, medical tests and a DXA scan. After completing Part 1 of the 6-month outcome assessment, participants will be given an activity monitor to wear at home for up to one week.
Approximately seven days after completing Part 1 of the 6-month outcome assessment, participants will complete Part 2. During Part 2 of the visit, participants will undergo a cardiorespiratory fitness test. A healthcare monitor will be available throughout testing to help ensure safety.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 290122 | OTHER_GRANT | Craig H. Neilsen Foundation | View |