Lifestyle Interventions for Seniors With Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Devon Dobrosielski, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01422863
First received: August 23, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
-Obstructive Sleep Apnea
Behavioral: Lifestyle Intervention
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
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)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422863

Contacts
Contact: Devon A Dobrosielski, PhD 410-550-5596 ddobros1@jhmi.edu
Contact: Anita Bacher, RN 410-550-5428 abacher@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Anita Bacher, RN    410-550-5428    abacher@jhmi.edu   
Sub-Investigator: Kerry J Stewart, EdD         
Sub-Investigator: Susheel Patil, MD         
Principal Investigator: Devon A Dobrosielski, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Devon A Dobrosielski, PhD Johns Hopkins School of Medicine
  More Information

No publications provided

Responsible Party: Devon Dobrosielski, Instructor in Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01422863     History of Changes
Other Study ID Numbers: LIZA
Study First Received: August 23, 2011
Last Updated: August 23, 2011
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
weight loss
exercise
diet
sleep apnea
aging

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014