Lifestyle Interventions for Seniors With Apnea
Recruitment status was Recruiting
The overall goal of this study is to determine the efficacy of a lifestyle intervention, consisting of a weight loss diet and exercise on sleep apnea in older adults. The investigators will conduct a 3-month intervention in men and women who are sedentary with suspected sleep apnea. The investigators hypothesize that the intervention will lead to marked improvements in sleep apnea severity and cardiovascular risk markers.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Weight Loss Through Diet and Exercise on Sleep Apnea Severity and Cardiovascular Risk in Older Adults|
- Polysomnography [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]Overnight Polysomnography will be used to measure Apnea-hypopnea index (AHI)- The number of arousals occurring over the course of the night
- Vascular Reactivity [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]The Endo-PAT2000 measures endothelium-mediated changes in vascular tone using biosensors that are attached to the fingertips
- maximal oxygen uptake [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]Testing is done on a treadmill. Participants will be asked to exercise to volitional fatigue
- Body composition assessment [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]Participants will undergo Dual Energy X-ray Absorptiometry to evaluate total and regional body composition.
- Muscle Strength [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]Strength testing of the thigh will be done using an isokinetic dynamometer
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: Lifestyle Intervention||
Behavioral: Lifestyle Intervention
Participants undergo 3 months of monitored exercise, consisting of aerobic and resistance training (3 days per week for 1 hour). Participants will also meet with a registered dietician, who will prescribe an American Heart Association low fat diet. The goal is to achieve a 1-2 lb weight loss per week.
Frailty, a condition characterized by a decrease in physiological reserve and increased risk for adverse health-related outcomes, is an increased risk of aging, especially in the presence of co-morbid conditions. Sleep apnea is also highly prevalent with increasing age. Both conditions share common pathologies, suggesting that sleep apnea may increase the risk of developing or exacerbate the consequences of frailty. Lifestyle interventions as strategies for treating sleep apnea and associated co-morbidities, thereby highlighting a feasible approach by which to reduce the incidence or progression of frailty. The specific aims of this study are to: 1) determine the effectiveness of a lifestyle intervention (LI), consisting of a weight loss diet and supervised exercise, on reducing sleep apnea in older adults, and 2) determine whether this intervention is effective at improving parameters that are common to both sleep apnea and frailty, such as poor physical functional capacity and body composition, impaired or abnormal cardiometabolic function and increased levels of inflammation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422863
|Contact: Devon A Dobrosielski, PhDfirstname.lastname@example.org|
|Contact: Anita Bacher, RNemail@example.com|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Anita Bacher, RN 410-550-5428 firstname.lastname@example.org|
|Sub-Investigator: Kerry J Stewart, EdD|
|Sub-Investigator: Susheel Patil, MD|
|Principal Investigator: Devon A Dobrosielski, PhD|
|Principal Investigator:||Devon A Dobrosielski, PhD||Johns Hopkins School of Medicine|