Lifestyle Interventions for Seniors With Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01422863
First received: August 23, 2011
Last updated: June 20, 2016
Last verified: June 2016

August 23, 2011
June 20, 2016
October 2010
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01422863 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Lifestyle Interventions for Seniors With Apnea
Effects of Weight Loss Through Diet and Exercise on Sleep Apnea Severity and Cardiovascular Risk in Older Adults
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.
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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
-Obstructive Sleep Apnea
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.
Experimental: Lifestyle Intervention
Intervention: Behavioral: Lifestyle Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • aged 60-75
  • BMI between 30-42
  • Apnea-Hypopnea Index above 10 events per hour (verified at baseline testing)

Exclusion Criteria:

  • currently following a weight loss diet
  • history of substance abuse
  • participating in moderate to vigorous activity most days of the week
  • history of cardiovascular disease
  • currently being treated for sleep apnea
  • current cigarette smoking
Both
60 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01422863
LIZA
Yes
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Devon A Dobrosielski, PhD Johns Hopkins School of Medicine
Johns Hopkins University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP