Advertisement

Topics

A Lifestyle Intervention Targeting Enhanced Health and Function for Persons With Chronic SCI in Caregiver/Care-Receiver Relationships: Effects of Caregiver Co-Treatment

2016-08-03 06:08:24 | BioPortfolio

Summary

This study determines in people with chronic SCI the health and functional impact and user acceptance and satisfaction - of a 6-month comprehensive Lifestyle Intervention; the impact and user acceptance/satisfaction of a Complementary Caregiver Curriculum (CCC) on SCI caregiver health and function and whether the complementary caregiver curriculum (CCC) enhances health and functional benefits obtained by the SCI dyadic partner enrolled in the LI program.

Description

The current proposal addresses the compelling problem of cardiometabolic disease risk and functional decline in persons with disability from spinal cord injuries and disease (SCI/D). 'Obesity/overweight' addressed in this project - a major component of CMD - represents the sole chronic condition whose speed of growth and widespread dispersion parallels pandemics of communicable diseases. Nearly 2/3 of Americans are currently overweight or obese, with a growth rate exceeding 10% in the past decade. The prevalence and impact of obesity is expected to worsen. Obesity-related health risks cross all lines of gender, geographic region, socioeconomic status, race, heritage, and educational level, and are strongly associated with comorbid conditions including: cardiometabolic syndrome, hypertension, diabetes, inflammatory disease, coronary artery disease, congestive heart failure, stroke, osteoarthritis, sleep apnea, depression, cancer, respiratory failure, disorders of coagulation, and degenerative joint disease. All of these disorders are widely reported at elevated prevalence in people with physical disability (PWPD). A study based on pooled data from the 1994-5 National Health Interview Survey, the 1994-5 Disability Supplement, and the 1995 'Healthy People 2000' Supplement reported a 66% higher rate of obesity among PWPD than the general population. A regional study reported that extreme obesity (body mass index [BMI] ≥ 40) was four times more prevalent among PWPD than those without. Prevalence rates for overweight and obesity in persons with chronic SCI/D are equally daunting, and range from 55% to 95.7% of the population. Numerous causes explain accretion of body fat after SCI including sarcopenia leading to loss of metabolically active muscle mass, reduced whole body energy expenditure, restricted choices for exercise conditioning, and a hypercaloric diet. Irrespective of cause, weight gain after disability brings about diminished work capacity, musculoskeletal decline, pain, accelerated cardiovascular diseases (CVD), and progressive life dissatisfaction. Overweight/obesity after SCI/D is also disturbingly co-morbid with dyslipidemia, glucose intolerance, and insulin resistance, a 'pro-inflammatory phenotype, and risks of postprandial lipemia. Increasing body mass (BM) promotes wheelchair injury and dysfunction, imposes significant burdens on self-image and perceived health, and is far more difficult to reverse than obesity occurring in persons without disability. Overweight in particular: a) Poses functional limitations, and restricts physical activity, independence, and community integration; b) affects ease of transferring, joint function, and fracture risk; and, c) compromises 'activities of daily living' (ADLs) in 39% of individuals with SCI. Despite all of these risks and concerns an effective solution to this problem has evaded researchers, clinicians, and stakeholders with SCI.

While an overweight body has implications for health and function of PWPD, it also has an impact on their caregivers. Within the past quarter decade there has been a predictable shift of many health and function related responsibilities to adjuvant providers (i.e., healthcare provider extenders) -- so-called 'caregivers' - who are challenged to administer greater health and functional demands of aging PWPD while they are similarly experiencing health and functional 3 decline accompanying their own aging. This shifting of providers will likely continue, or possibly worsen due to an uncertain future of disability coverage within a tentative American health system. We have already started to observe - yet not fully comprehend - the many complex difficulties imposed by aging on PWPD and their caregivers, and speculate how to effectively intervene on them. Unlike caregivers for persons with Alzheimer's disease and Parkinson's disease, caregivers of people with wheelchair dependency are required to be more physically active, lift/push/roll an impaired body far more often, and often assume caregiving responsibilities earlier in the life of PWPD. While clinicians and researchers often focus on the person with disability, their caregiver can be left out of the care plan. It is thus not surprising that pain, anxiety, and depression among caregivers of PWPD is exceedingly prevalent.

Encouraging evidence already suggests an important role for primary and secondary lifestyle intervention (LI) in the form of weight-lessening and fitness-promoting nutrition and exercise to improve health and function of people aging with disability. Comprehensive LI programs of exercise, nutrition, and behavioral support for people without disabilities have been designed and systematically tested in multi-center clinical trials, and have been found effective in the short term for promoting weight loss and lessening conversion rates to frank diabetes. The LI programs have been compared against pharmacotherapy and have actually been found more effective. Programmatic modifications made for community deployment of the LI plans, and testing of long-term follow-up have shown remarkable success in sustaining - or even further improving - benefits obtained during initial treatment. These research findings make LI programs of weight-loss promoting reconditioning exercise, nutrition, and behavioral support legitimate candidates for testing in PWPD, although no studies have ever done so. Moreover, the impact of these interventions on caregiver burden has never been examined, although it is reasonable to conjecture that loss of body BM and improved fitness/function of care-receivers would reduce global caregiver burden. Further, evidence supports lifestyle and health benefits to the care-receiver when a caregiver is enrolled in a linked behavioral intervention program, making the relationship of the dyadic partners in benefitting one another through coordinated intervention an intriguing intervention benefit.

To: a) address the concerning problem of overweight/obesity after SCI, b) better understand its impact on health and function of persons with SCI and their caregivers, and c) intervene on these hazards where inaction would forecast additional decline, we will conduct a randomized, controlled, multi-center intervention study examining persons with disability from SCI and their caregivers, who will together be enrolled as dyadic partners. Key questions will address whether: a) people with disability from SCI benefit from the LI plan through improved health and function, b) caregivers of people with disability from SCI benefit from the LI plan through their own improved health and function, c) co-participation of a caregiver partner in a LI curriculum provides a cross benefit for their partner, and d) benefits of clinical intervention are long-lasting with minimal supervision. We will use an intervention for all participants with SCI that is modeled after the Diabetes Prevention Program (DPP) that incorporates population-appropriate exercise, nutrition, and behavioral support. Caregivers (linked with their partners) will be randomized to either 'behavioral support' or a 'control condition'. Clinical training will take place for 6 months and then be followed by a 6-month minimally supervised extension phase. Outcomes tested for participants with SCI will focus on domains of health and function reflected by fitness, cardioendocrine risk and inflammatory stress; multi-dimensional function and pain; Sol and independence; and self-efficacy, program acceptance, and life satisfaction. Outcomes tested for caregivers will focus on multidimensional function and pain; and, QoL and independence, the latter including perceived caregiver burden.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Spinal Cord Injury

Intervention

Spinal Cord Injury (SCI), Caregiver Intervention(CCC), Caregiver Control (CC)

Location

Craig Hospital
Englewood
Colorado
United States
80113

Status

Recruiting

Source

University of Miami

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-03T06:08:24-0400

Clinical Trials [4065 Associated Clinical Trials listed on BioPortfolio]

Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury

The overall objective of this project is to test the efficacy of an innovative multi-component intervention aimed at reducing the risk for adverse health outcomes among caregivers of older...

Supporting Patient Decisions About UE Surgery in Cervical SCI

The goal of this study is to collect and describe patient and caregiver reported outcomes regarding surgical and non-surgical treatment for improving hand and arm function in the setting o...

In-Home Adjustment of New Spinal Cord Injury Caregivers

To improve spinal cord injury (SCI) rehabilitation through stronger informal caregiving, the proposed study will modify and evaluate a telehealth Transition Assistance Program (TAP) for in...

Walking Adaptability Post-Spinal Cord Injury

The purpose of this study is: (1) to establish assessment techniques (in our laboratory) to identify the functional integrity of long spinal tracts associated with adaptive walking recover...

Injured Spinal Cord Pressure Evaluation

About a thousand people a year in the United Kingdom survive a spinal cord injury but are left paralysed or wheelchair-bound. The annual cost of care for spinal cord injury victims is more...

PubMed Articles [16894 Associated PubMed Articles listed on BioPortfolio]

Acute Thoracolumbar Spinal Cord Injury: Relationship of Cord Compression to Neurological Outcome.

Spinal cord injury in the cervical spine is commonly accompanied by cord compression and urgent surgical decompression may improve neurological recovery. However, the extent of spinal cord compression...

Dexmedetomidine Preconditioning Ameliorates Inflammation and Blood-Spinal Cord Barrier Damage after Spinal Cord Ischemia-Reperfusion Injury by Down-Regulation High Mobility Group Box 1-Toll-Like Receptor 4-Nuclear Factor κB Signaling Pathway.

To evaluate the effect of Dexmedetomidine (Dex) on the inflammatory response and the integrity of blood-spinal cord barrier (BSCB) after spinal cord ischemia-reperfusion injury (SCIRI).

Research progress in the role of aquaproin-4 and inward rectifying potassium channel 4.1 in spinal cord edema.

Spinal edema is a very important pathophysiological basis for secondary spinal cord injury, which affects the repair and prognosis of spinal cord injury. Aquaporin-4 is widely distributed in various o...

Determining the spiritual well-being of patients with spinal cord injury.

The present study was designed to determine the spiritual belief levels of patients with spinal cord injury as well as to examine the socio-demographic factors that affect their spiritual beliefs.

Location, length, and enhancement: systematic approach to differentiating intramedullary spinal cord lesions.

Intramedullary spinal cord abnormalities are often challenging to diagnose. Spinal cord biopsy is a high-risk procedure with the potential to cause permanent neurological injury. Magnetic resonance im...

Medical and Biotech [MESH] Definitions

Repair of the damaged neuron function after SPINAL CORD INJURY or SPINAL CORD DISEASES.

Reduced blood flow to the spinal cord which is supplied by the anterior spinal artery and the paired posterior spinal arteries. This condition may be associated with ARTERIOSCLEROSIS, trauma, emboli, diseases of the aorta, and other disorders. Prolonged ischemia may lead to INFARCTION of spinal cord tissue.

A syndrome associated with traumatic injury to the cervical or upper thoracic regions of the spinal cord characterized by weakness in the arms with relative sparing of the legs and variable sensory loss. This condition is associated with ischemia, hemorrhage, or necrosis involving the central portions of the spinal cord. Corticospinal fibers destined for the legs are spared due to their more external location in the spinal cord. This clinical pattern may emerge during recovery from spinal shock. Deficits may be transient or permanent.

Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.

Ischemia or infarction of the spinal cord in the distribution of the anterior spinal artery, which supplies the ventral two-thirds of the spinal cord. This condition is usually associated with ATHEROSCLEROSIS of the aorta and may result from dissection of an AORTIC ANEURYSM or rarely dissection of the anterior spinal artery. Clinical features include weakness and loss of pain and temperature sensation below the level of injury, with relative sparing of position and vibratory sensation. (From Adams et al., Principles of Neurology, 6th ed, pp1249-50)

More From BioPortfolio on "A Lifestyle Intervention Targeting Enhanced Health and Function for Persons With Chronic SCI in Caregiver/Care-Receiver Relationships: Effects of Caregiver Co-Treatment"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Complementary and Alternative Medicine
Alternative medicine are whole medical systems that did not fit with conventional medicine as they have completely different philosophies and ideas on the causes of disease, methods of diagnosis and approaches to treatment. Although often overlapping, co...

Collaborations in biotechnology
Commercial and academic collaborations are used throughout the biotechnology and pharmaceutical sector to enhance research and product development. Collaborations can take the form of research and evaluation agreements, licensing, partnerships etc. ...

Spinal Cord Disorders
The spinal cord is a bundle of nerves that runs down the middle of the back which carry signals back and forth between the body and brain. It is protected by vertebrae, which are the bone disks that make up the spine. An accident that damages the verte...


Searches Linking to this Trial