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View Clinical Trial (Medical Research Study)
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Effects of a Weight Reduction and Lifestyle Program in Older Adults - NCT00714506-15132 (Clinical Trial 230777)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy230777.aspx
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** Please review additional "Nearby Studies" on right ----->
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| City: |
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McKeesport |
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State:
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PA |
| Zip Code: |
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15132 |
| Conditions: |
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Functional Disability - Obesity - Physical Inactivity |
| Purpose: |
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This research study will assess the effects of two different programs on weight, body
composition, mobility and improved health. Measures of health will include functional
abilities, and physical performance. The 2 programs being tested will be provided the same
physical activity program which will include aerobic activity and resistance (weight)
training. The intervention study will last up to 1 year with follow-up at 6 months and
yearly phone calls thereafter.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Age 65 and older
- BMI 28 to 39.9
- Sedentary lifestyle defined by formal exercise less than 3 times per week for a total
of less than 90 minutes.
- Self report of ability to walk ¼ mile (2-3 blocks)
- Ability to complete the 400 meter walk without a cane or walker in less than 15
minutes
- Successful completion of the behavioral run-in phase which includes an activity log
and a food diary
- Willingness to be randomized to either intervention group
- Willingness to attend meetings and physical activity sessions in McKeesport
Exclusion Criteria:
- Diabetes requiring insulin, history of diabetic coma, or diabetes out of control
defined as fasting blood sugar greater than 300
- Severe hypertension, e.g. SBP> 180, DBP > 100
- Failure to provide informed consent
- Nursing home resident or resident in a facility where they have no control over food
choices
- Significant cognitive impairment, defined as a known diagnosis of dementia or a 3MSE
Cognitive Function score < 80
- Major psychiatric disorder
- Unable to communicate because of severe hearing loss or speech disorder
- Severe visual impairment
- Celiac sprue or other malabsorption syndromes
- Consume more than 5 alcoholic drinks per day, or more than 15 drinks per week
- Progressive, degenerative neurological disease
- Severe rheumatologic or orthopedic diseases
- Stroke, hip, or knee replacement, or spinal surgery within the past 4 months or
planned in the next 4 months
- Receiving physical therapy for gait, balance, or lower extremity training
- Terminal illness with life expectancy of less than 12 months
- Currently being treated with chemotherapy or radiation for breast, cervical, colon,
prostate, rectal, uterine, thyroid, or oral cancer. Participant with other types of
cancers, with the exception of basal and squamous cancer are ineligible
- Severe pulmonary disease (i.e., lung disease requiring supplemental oxygen or oral
steroid medication) or pulmonary embolism or deep vein thrombosis within the past 6
months
- Severe cardiac disease (i.e., congestive heart failure (NYHA Class III or IV);
untreated aortic stenosis; a history of cardiac arrest, the use of a cardiac
defibrillator or uncontrolled angina)
- Myocardial infarction, CABG, or valve replacement in the past 6 months
- Serious conduction disorder (3rd degree heart block), uncontrolled arrhythmia, or new
Q waves or ST- segment depressions (> 3mm) on ECG
- Other significant co-morbid disease that the study medical officer deems severe
enough to impair ability to participate in exercise based intervention
- Severe kidney disease that requires dialysis
- Develops chest pain or severe shortness of breath during 400 m walk test
- Member of household is already enrolled
- Participation in another intervention trial: participation in an observational study
is permitted
- People who have lost more than 10 pounds in the past 4 months, or are on any drugs
for the treatment of obesity
- Lives outside of the study site area or is planning to move in the next year
- Must be able to attend at least 6 of the first 8 weekly sessions. |
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| Study is available at: |
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McKeesport Hospital - Kelly Building
McKeesport, PA 15132
United States
Primary Contact:
Alice Valoski, MS, RD
Email: valoskia@edc.pitt.edu
Phone: 412-383-3139
Secondary Contact:
Alice Valoski, MS, RD
Email: valoskia@edc.pitt.edu
Phone: 412 624 3139 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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