High Blood Pressure, Hypertension, Sarcopenia
Conditions
Keywords
cardiovascular disease prevention, aging, exercise, blood pressure, sarcopenia, resistance training, older adults
Brief summary
Current prevention and treatment of high blood pressure (BP) in sarcopenia, by non-pharmacological approaches remain limited and are far from optimal. This randomized control intervention pilot study will provide new evidence of the unexplored relationship between muscle strength and high BP in sarcopenia, and experimentally test the effects of an evidence-based progressive resistance training intervention on BP, while also examining reversibility to identify muscle strength as a non-pharmacological target for BP control in older sarcopenic adults.
Detailed description
This premise of this K01 proposal is to address current gaps in the literature regarding the understanding of high blood pressure due to sarcopenia, and provide new evidence for the discernible relationship between low muscle strength and blood pressure in sarcopenia, and effective non-pharmaceutical treatment approaches. This study will evaluate the feasibility of recruitment, retention, implementation and adherence to an empirically-based progressive resistance training (PRT) intervention to test its effect on blood pressure in a targeted population of older adults with sarcopenia who are randomized (via block permuted scheme) to the PRT intervention. Built within this randomized control intervention design, the investigators will further explore reversibility to examine whether muscle strength serves as an intervention target for blood pressure control in sarcopenic adults, which will be more appropriately tested in subsequently well-powered R-level intervention studies. Physiologically plausible microvascular mechanisms by which the PRT impacts changes in blood pressure will also be explored.
Interventions
BEHAVIORALprogressive resistance training
Individual, tailored, progressive muscle strength and function intervention
Sponsors
University of Illinois at Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Primary investigator will be masked to the outcome data collection
Intervention model description
permuted block randomization scheme,
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults (men and women) aged 60 years and older (any racial/ethnic background) * Demonstrates adequate cognitive function by the MoCA (education adjusted score of \>22 at screening) * Sedentary or low active adults (not active in strength training) * Resides in the Chicagoland Area * Able to walk/perform exercise without complete dependence on assisted device * Able and willing to enroll and provide written informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to 1 of 2 treatment arms, follow through assignment during 3 months active period, participate in 1 follow-up visit at 12 months
Exclusion criteria
* Subjects with self-report of inability to walk at least ¼ mile or walk 400 meters in \<15 minutes without sitting * Subjects who self-reported having a history of a cardiovascular disease event or physician diagnosed cardiovascular disease (heart attack, heart failure, congenital heart disease, peripheral vascular disease, coronary revascularization, or angina that required overnight hospitalization), cerebrovascular disease (stroke, transient ischemic attack) * Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 5 years; * Subjects with orthopedic pathology or deformity that prevents exercising safely * Diagnosis or history of cognitive impairment (Dementia, Alzheimer's Disease) or bipolar or psychotic disorder or hospitalization for psychological or emotional problems within the last 2 years * Diagnosis of autoimmune diseases, such as (but not limited to) lupus, multiple sclerosis, advanced/severe rheumatoid arthritis that would preclude exercising safely * Diagnosis of advanced or severe osteoporosis or orthopedic deformities that may prevent strength training exercise safely * Participants from the same household as those already enrolled in the study * Current abuser of alcohol or usage of illicit drugs or history of alcohol or drug abuse * Planning to move out of the area or take an extended vacation during the study period * Current or planned participation in in another structured program that overtly focuses on exercise * Currently enrolled or planning to enroll into another research study that would limit full participation in the study * Investigator discretion for clinical safety or protocol adherence reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | baseline, 12 weeks | change in systolic and diastolic blood pressure |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeepika Laddu, PhD
Northwestern University
Participant flow
Recruitment details
Recruitment dates: 01/27/2020 through September 2022. Recruitment was temporarily paused from 03/06/2020 through July 2020 due to the COVID pandemic and university mandated closures of research. Recruitment resumed in August 2020
Pre-assignment details
After enrollment, study eligibility was confirmed via hand grip strength assessment. Clinically meaningful weakness will determine study eligibility is defined as a grip strength \<30kg in men and \<20kg in women. Adults who do not meet the cutoff for low sex-specific grip strength were ineligible to continue.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 6.18 |
| body mass index | 30.8 kg per meters squared STANDARD_DEVIATION 8.55 |
| grip strength | 18.3 kg STANDARD_DEVIATION 4.5 |
| Race/Ethnicity, Customized Black | 24 participants |
| Race/Ethnicity, Customized Not Black | 40 participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 45 |
| other Total, other adverse events | 0 / 26 | 0 / 45 |
| serious Total, serious adverse events | 0 / 26 | 0 / 45 |
Outcome results
None listed