Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061490
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2003-05-28
Brief Title:
The Effect of Weight Loss and Exercise on Knee Osteoarthritis
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
The Impact of Weight Loss and Exercise on Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate whether a program of weight loss and exercise can help individuals with knee osteoarthritis OA
Detailed Description:
Knee OA is a major public health challenge affecting millions of people in the United States Obesity is a primary target for intervention since it accounts for up to 30 of knee OA exacerbates symptoms and is associated with bilateral involvement and more rapid progression of the disease While the American College of Rheumatology ACR Practice Guidelines recommend modest weight loss as symptomatic therapy no published clinical trials have investigated the impact of weight loss on knee OA
Physical activity has also been associated with pain reduction and increased mobility in individuals with knee OA and the ACR Practice Guidelines indicate that it should be included in treatment Exercise may be especially helpful for overweight persons with knee OA as it is a potent predictor of weight loss maintenance Though adherence to traditional exercise programs has been poor adopting lifestyles in which exercise is accumulated throughout the day appears to be a promising new approach to physical activity Lifestyle exercise may enhance exercise adherence by increasing options to be active and reducing time barriers Episodic physical activity may also be preferable to continuous exercise by reducing pain and avoiding injury The primary objective of this proposal is to evaluate the impact of weight loss and lifestyle exercise on knee osteoarthritis
Participants will be randomly assigned to either a behavioral weight loss and exercise program or a delayed intervention group Participants in the behavioral weight loss and exercise group will attend weekly group meetings at the Johns Hopkins Bayview Medical Center for 16 weeks Group meetings last about 1 hour and are led by health care professionals Participants will be taught how to lose weight and keep weight off by changing what they eat and evaluating their lifestyle Participants will be instructed on a safe and effective diet plan 1200 caloriesday for women 1500 caloriesday for men and will be asked to increase their physical activity to about 30 minutes per day of brisk walking most days of the week After the 16-week program groups will continue to meet every three months for 1 year to help sustain lifestyle changes
The delayed intervention group will receive the program described above after a 4-month waiting period
The primary outcome measure will be knee pain Secondary measures include physical disability quality of life performance measures and long-term adherence to behavior change
Physical activity has also been associated with pain reduction and increased mobility in individuals with knee OA and the ACR Practice Guidelines indicate that it should be included in treatment Exercise may be especially helpful for overweight persons with knee OA as it is a potent predictor of weight loss maintenance Though adherence to traditional exercise programs has been poor adopting lifestyles in which exercise is accumulated throughout the day appears to be a promising new approach to physical activity Lifestyle exercise may enhance exercise adherence by increasing options to be active and reducing time barriers Episodic physical activity may also be preferable to continuous exercise by reducing pain and avoiding injury The primary objective of this proposal is to evaluate the impact of weight loss and lifestyle exercise on knee osteoarthritis
Participants will be randomly assigned to either a behavioral weight loss and exercise program or a delayed intervention group Participants in the behavioral weight loss and exercise group will attend weekly group meetings at the Johns Hopkins Bayview Medical Center for 16 weeks Group meetings last about 1 hour and are led by health care professionals Participants will be taught how to lose weight and keep weight off by changing what they eat and evaluating their lifestyle Participants will be instructed on a safe and effective diet plan 1200 caloriesday for women 1500 caloriesday for men and will be asked to increase their physical activity to about 30 minutes per day of brisk walking most days of the week After the 16-week program groups will continue to meet every three months for 1 year to help sustain lifestyle changes
The delayed intervention group will receive the program described above after a 4-month waiting period
The primary outcome measure will be knee pain Secondary measures include physical disability quality of life performance measures and long-term adherence to behavior change
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-080 | US NIH GrantContract | None | httpsreporternihgovquickSearchK23AR002160 |
| K23AR002160 | NIH | None | None |