Exercise and Weight Loss for Improving Mobility in Older Adults Who Are Obese

NCT00119795 | Completed DMC

• 3 other identifiers: 197R01HL076441R01HL076441-01
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 3

Brief Summary

To test the effects of exercise and weight loss on mobility disability of older overweight/obese men and women who have evidence of cardiovascular disease or the metabolic syndrome.

Conditions

Cardiovascular Diseases; Heart Diseases; Metabolic Syndrome X; Obesity

Outcome Measures

Primary Outcomes (1)

• 400 meter walk

  Measured at 18 months

Study Arms (3)

Health education control

ACTIVE COMPARATOR

This is an education program for older adults entitles, successful aging.

Behavioral: Health Education Control

Exercise Only

EXPERIMENTAL

Structured exercise 150 min/wk

Behavioral: Exercise

Weight Loss

EXPERIMENTAL

Behavioral weight loss; goal of 7%

Behavioral: Weight Loss

Interventions

Exercise BEHAVIORAL

Increase Physical Activity to 150 min/wk

Also known as: Physical activity

Exercise Only

Weight Loss BEHAVIORAL

Lose 7-10% of body weight and increase physical activity to 150 min/wk

Also known as: Diet modification

Weight Loss

Health Education Control BEHAVIORAL

Lectures on information relevant to successful aging

Also known as: Attention control

Health education control

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently living in one of the counties surrounding Winston-Salem, NC
• Sedentary (engages in fewer than 30 minutes of moderate structured physical activity for at least 10 minutes at a time each week)
• Overweight or obese, as defined by a body mass index (BMI) greater than 25
• Fasting glucose level less than 140
• Documented evidence of an MI, PCTA, chronic stable angina, or cardiovascular surgery (coronary artery or valvular heart disease) within the 6 months prior to study entry or an ATP III diagnosis of the metabolic syndrome
• Disability defined as self-reported difficulty with walking ¼ mile, climbing stairs, lifting and carrying groceries, or performing other household chores such as cleaning and yard work
• Does not plan to move out of the county of residence for the duration of the study

You may not qualify if:

• Diagnosis of bipolar depression or schizophrenia (defined as self-reported treatment for these conditions)
• Currently receiving lithium or neuroleptics
• Evidence of unstable angina, symptomatic congestive heart failure, or exercise-induced complex ventricular arrhythmias
• Resting blood pressure greater than 160/100 mmHg
• Diagnosis of any of the following: Parkinson's disease; chronic liver disease (cirrhosis, chronic hepatitis, etc.); systemic rheumatic condition (rheumatoid arthritis, psoriatic arthritis, Reiter's disease, systemic lupus erythematosus, etc.); end stage renal disease; or other systemic diseases or abnormal laboratory values which would preclude participants from safely participating in the protocol or impair their ability to complete the study
• Actively being treated for cancer (other than non-melanotic skin cancer)
• Significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation
• Currently participating in or planning to participate in another medical intervention study
• Current alcohol abuse disorder or consumes more than 21 alcoholic drinks per week
• Unable to walk without assistance
• Unable to speak or read English
• Judged by the clinic staff to be unsuitable for the trial for any reason

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Guilford County, North Carolina Cooperative Extension Center

Greensboro, North Carolina, 27405, United States

Location

Davidson County Coopertive Extension

Lexington, North Carolina, 27292, United States

Location

Forsyth County Cooperative Extension Center

Winston-Salem, North Carolina, 27105, United States

Location

Related Publications (2)

• Brawley L, Rejeski WJ, Gaukstern JE, Ambrosius WT. Social cognitive changes following weight loss and physical activity interventions in obese, older adults in poor cardiovascular health. Ann Behav Med. 2012 Dec;44(3):353-64. doi: 10.1007/s12160-012-9390-5.

  PMID: 22773225 DERIVED

• Rejeski WJ, Brubaker PH, Goff DC Jr, Bearon LB, McClelland JW, Perri MG, Ambrosius WT. Translating weight loss and physical activity programs into the community to preserve mobility in older, obese adults in poor cardiovascular health. Arch Intern Med. 2011 May 23;171(10):880-6. doi: 10.1001/archinternmed.2010.522. Epub 2011 Jan 24.

  PMID: 21263080 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Metabolic Syndrome; Obesity

Interventions

Exercise; Diet Therapy

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics

Study Officials

• Walter Rejeski

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2005
• First Posted: July 14, 2005
• Study Start: August 1, 2005
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)