Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment : A Study Protocol of a Multisite Randomized Controlled Trial
BACKGROUND: Chronic spinal cord injury (SCI) significantly accelerates morbidity and mortality, partly due to the increased risk of cardiometabolic diseases (CMD), including neurogenic obesity, dyslipidemia, and impaired glucose metabolism. While exercise and dietary interventions have shown some transient benefits in reducing CMD risk, they often fail to improve clinically relevant disease markers and cardiovascular events. Moreover, SCI also places caregiving demands on their caregivers, who themselves experience health and functional decline. This underscores the need for more substantial interventions that incorporate appropriate physical activity, heart-healthy nutrition, and behavioral support tailored to the SCI population.
OBJECTIVES: This randomized clinical trial (RCT) protocol will (1) assess the health and functional effects, user acceptance, and satisfaction of a 6-month comprehensive therapeutic lifestyle intervention (TLI) adapted from the National Diabetes Prevention Program (DPP) for individuals with chronic SCI and (2) examine the impact of a complementary caregiver program on the health and function of SCI caregivers and evaluate user acceptance and satisfaction. Caregivers (linked with their partners) will be randomized to 'behavioral support' or 'control condition'.
METHODS: Dyadic couples comprise individuals with SCI (18-65 years, >1-year post-injury, ASIA Impairment Scale A-C, injury levels C5-L1) and non-disabled SCI caregivers (18-65 years). Both groups undergo lock-step circuit resistance training, a calorie-restricted Mediterranean-style diet, and 16 educational sessions focused on diet/exercise goals, self-monitoring, psychological and social challenges, cognitive behavioral therapy, and motivational interviewing. The outcome measures encompass the cardiometabolic risks, cardiorespiratory fitness, inflammatory stress, multidimensional function, pain, life quality, independence, self-efficacy, program acceptance, and life satisfaction for SCI participants. The caregiver outcomes include multidimensional function, pain, quality of life, independence, and perceived caregiver burden.
DISCUSSION/CONCLUSIONS: This study evaluates the effects and durability of a structured, multi-modal intervention on health and function. The results and intervention material will be disseminated to professionals and consumers for broader implementation.
TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02853149 Registered 2 August 2016.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
|---|---|
| Enthalten in: |
International journal of environmental research and public health - 20(2023), 19 vom: 25. Sept. |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Bigford, Gregory E [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Behavioral modification |
|---|
| Anmerkungen: |
Date Completed 01.11.2023 Date Revised 01.11.2023 published: Electronic ClinicalTrials.gov: NCT02853149 Citation Status MEDLINE |
|---|
| doi: |
10.3390/ijerph20196819 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM363280561 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM363280561 | ||
| 003 | DE-627 | ||
| 005 | 20231226093014.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3390/ijerph20196819 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1210.xml |
| 035 | |a (DE-627)NLM363280561 | ||
| 035 | |a (NLM)37835090 | ||
| 035 | |a (PII)6819 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Bigford, Gregory E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment |b A Study Protocol of a Multisite Randomized Controlled Trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 01.11.2023 | ||
| 500 | |a Date Revised 01.11.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02853149 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Chronic spinal cord injury (SCI) significantly accelerates morbidity and mortality, partly due to the increased risk of cardiometabolic diseases (CMD), including neurogenic obesity, dyslipidemia, and impaired glucose metabolism. While exercise and dietary interventions have shown some transient benefits in reducing CMD risk, they often fail to improve clinically relevant disease markers and cardiovascular events. Moreover, SCI also places caregiving demands on their caregivers, who themselves experience health and functional decline. This underscores the need for more substantial interventions that incorporate appropriate physical activity, heart-healthy nutrition, and behavioral support tailored to the SCI population | ||
| 520 | |a OBJECTIVES: This randomized clinical trial (RCT) protocol will (1) assess the health and functional effects, user acceptance, and satisfaction of a 6-month comprehensive therapeutic lifestyle intervention (TLI) adapted from the National Diabetes Prevention Program (DPP) for individuals with chronic SCI and (2) examine the impact of a complementary caregiver program on the health and function of SCI caregivers and evaluate user acceptance and satisfaction. Caregivers (linked with their partners) will be randomized to 'behavioral support' or 'control condition' | ||
| 520 | |a METHODS: Dyadic couples comprise individuals with SCI (18-65 years, >1-year post-injury, ASIA Impairment Scale A-C, injury levels C5-L1) and non-disabled SCI caregivers (18-65 years). Both groups undergo lock-step circuit resistance training, a calorie-restricted Mediterranean-style diet, and 16 educational sessions focused on diet/exercise goals, self-monitoring, psychological and social challenges, cognitive behavioral therapy, and motivational interviewing. The outcome measures encompass the cardiometabolic risks, cardiorespiratory fitness, inflammatory stress, multidimensional function, pain, life quality, independence, self-efficacy, program acceptance, and life satisfaction for SCI participants. The caregiver outcomes include multidimensional function, pain, quality of life, independence, and perceived caregiver burden | ||
| 520 | |a DISCUSSION/CONCLUSIONS: This study evaluates the effects and durability of a structured, multi-modal intervention on health and function. The results and intervention material will be disseminated to professionals and consumers for broader implementation | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02853149 Registered 2 August 2016 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, U.S. Gov't, Non-P.H.S. | |
| 650 | 4 | |a SCI | |
| 650 | 4 | |a behavioral modification | |
| 650 | 4 | |a cardiometabolic disease | |
| 650 | 4 | |a exercise | |
| 650 | 4 | |a intervention | |
| 650 | 4 | |a metabolism | |
| 650 | 4 | |a nutrition | |
| 650 | 4 | |a rehabilitation | |
| 700 | 1 | |a Betancourt, Luisa F |e verfasserin |4 aut | |
| 700 | 1 | |a Charlifue, Susan |e verfasserin |4 aut | |
| 700 | 1 | |a Nash, Mark S |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t International journal of environmental research and public health |d 2004 |g 20(2023), 19 vom: 25. Sept. |w (DE-627)NLM162777434 |x 1660-4601 |7 nnns |
| 773 | 1 | 8 | |g volume:20 |g year:2023 |g number:19 |g day:25 |g month:09 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3390/ijerph20196819 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 20 |j 2023 |e 19 |b 25 |c 09 | ||