Clinical trial NCT04255745: The Impact of a Resistance Training Intervention on Blood Pressure Control in Older Adults With Sarcopenia
Official title: The Impact of a Resistance Training Intervention on Blood Pressure Control in Older Adults With Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
High Blood Pressure
Hypertension
Keywords: cardiovascular disease prevention
muscle weakness
aging
exercise
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-02-05
Enrollment: 77
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: permuted block randomization scheme,
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in blood pressure
timeFrame: baseline, 12 weeks, 1 year
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: baseline, 12 weeks, 1 year
measure: Timed up and go performance
timeFrame: baseline, 12 weeks, 1 year
Other outcomes:
measure: Muscle strength
timeFrame: baseline, 8 weeks 12 weeks, 1 year
measure: Microvascular flow-induced vasodilation (FID) dose response
timeFrame: baseline, 12 weeks
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: UIC
name: Deepika Laddu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laddu D, Kim H, Phillips SA, Ma J. INERTIA: A pilot study of the impact of progressive resistance training on blood pressure control in older adults with sarcopenia. Contemp Clin Trials. 2021 Sep;108:106516. doi: 10.1016/j.cct.2021.106516. Epub 2021 Jul 24.