Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02853149 |
| Other study ID # |
20151065 |
| Secondary ID |
90DP0074-01-00 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 26, 2016 |
| Est. completion date |
September 23, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
University of Miami |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 cardiometabolic disease
risk (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. The investigators 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 benefiting 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, the investigators 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. The
investigators 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, Quality of Life
(QoL) and independence, the latter including perceived caregiver burden.
