Dataset Information

Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial.

ABSTRACT:

Importance

Knee osteoarthritis (OA), a common cause of chronic pain and disability, has biomechanical and inflammatory origins and is exacerbated by obesity.

Objective

To determine whether a ?10% reduction in body weight induced by diet, with or without exercise, would improve mechanistic and clinical outcomes more than exercise alone.

Design, setting, and participants

Single-blind, 18-month, randomized clinical trial at Wake Forest University between July 2006 and April 2011. The diet and exercise interventions were center-based with options for the exercise groups to transition to a home-based program. Participants were 454 overweight and obese older community-dwelling adults (age ?55 years with body mass index of 27-41) with pain and radiographic knee OA.

Interventions

Intensive diet-induced weight loss plus exercise, intensive diet-induced weight loss, or exercise.

Main outcomes and measures

Mechanistic primary outcomes: knee joint compressive force and plasma IL-6 levels; secondary clinical outcomes: self-reported pain (range, 0-20), function (range, 0-68), mobility, and health-related quality of life (range, 0-100).

Results

Three hundred ninety-nine participants (88%) completed the study. Mean weight loss for diet + exercise participants was 10.6 kg (11.4%); for the diet group, 8.9 kg (9.5%); and for the exercise group, 1.8 kg (2.0%). After 18 months, knee compressive forces were lower in diet participants (mean, 2487 N; 95% CI, 2393 to 2581) compared with exercise participants (2687 N; 95% CI, 2590 to 2784, pairwise difference [?](exercise vs diet?)=?200 N; 95% CI, 55 to 345; P?=?.007). Concentrations of IL-6 were lower in diet + exercise (2.7 pg/mL; 95% CI, 2.5 to 3.0) and diet participants (2.7 pg/mL; 95% CI, 2.4 to 3.0) compared with exercise participants (3.1 pg/mL; 95% CI, 2.9 to 3.4; ?(exercise vs diet + exercise)?=?0.39 pg/mL; 95% CI, -0.03 to 0.81; P?=?.007; ?(exercise vs diet?)=?0.43 pg/mL; 95% CI, 0.01 to 0.85, P?=?.006). The diet + exercise group had less pain (3.6; 95% CI, 3.2 to 4.1) and better function (14.1; 95% CI, 12.6 to 15.6) than both the diet group (4.8; 95% CI, 4.3 to 5.2) and exercise group (4.7; 95% CI, 4.2 to 5.1, ?(exercise vs diet + exercise)?=?1.02; 95% CI, 0.33 to 1.71; P(pain)?=?.004; 18.4; 95% CI, 16.9 to 19.9; ?(exercise vs diet + exercise), 4.29; 95% CI, 2.07 to 6.50; P(function?)Conclusions and relevanceAmong overweight and obese adults with knee OA, after 18 months, participants in the diet + exercise and diet groups had more weight loss and greater reductions in IL-6 levels than those in the exercise group; those in the diet group had greater reductions in knee compressive force than those in the exercise group.

Trial registration

clinicaltrials.gov Identifier: NCT00381290.

SUBMITTER: Messier SP

PROVIDER: S-EPMC4450354 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial.

Messier Stephen P SP Mihalko Shannon L SL Legault Claudine C Miller Gary D GD Nicklas Barbara J BJ DeVita Paul P Beavers Daniel P DP Hunter David J DJ Lyles Mary F MF Eckstein Felix F Williamson Jeff D JD Carr J Jeffery JJ Guermazi Ali A Loeser Richard F RF

JAMA 20130901 12

<h4>Importance</h4>Knee osteoarthritis (OA), a common cause of chronic pain and disability, has biomechanical and inflammatory origins and is exacerbated by obesity.<h4>Objective</h4>To determine whether a ≥10% reduction in body weight induced by diet, with or without exercise, would improve mechanistic and clinical outcomes more than exercise alone.<h4>Design, setting, and participants</h4>Single-blind, 18-month, randomized clinical trial at Wake Forest University between July 2006 and April 20 ...[more]

PMID: 24065013

Similar Datasets

Project description:ImportanceSome weight loss and exercise programs that have been successful in academic center-based trials have not been evaluated in community settings.ObjectiveTo determine whether adaptation of a diet and exercise intervention to community settings resulted in a statistically significant reduction in pain, compared with an attention control group, at 18-month follow-up.Design, setting, and participantsAssessor-blinded randomized clinical trial conducted in community settings in urban and rural counties in North Carolina. Patients were men and women aged 50 years or older with knee osteoarthritis and overweight or obesity (body mass index ≥27). Enrollment (N = 823) occurred between May 2016 and August 2019, with follow-up ending in April 2021.InterventionsPatients were randomly assigned to either a diet and exercise intervention (n = 414) or an attention control (n = 409) group for 18 months.Main outcomes and measuresThe primary outcome was the between-group difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain score (range, 0 [none] to 20 [severe]; minimum clinically important difference, 1.6) over 18 months, tested using a repeated-measures mixed linear model with adjustments for covariates. There were 7 secondary outcomes including body weight.ResultsAmong the 823 randomized patients (mean age, 64.6 years; 637 [77%] women), 658 (80%) completed the trial. At 18-month follow-up, the adjusted mean WOMAC pain score was 5.0 in the diet and exercise group (n = 329) compared with 5.5 in the attention control group (n = 316) (adjusted difference, -0.6; 95% CI, -1.0 to -0.1; P = .02). Of 7 secondary outcomes, 5 were significantly better in the intervention group compared with control. The mean change in unadjusted 18-month body weight for patients with available data was -7.7 kg (8%) in the diet and exercise group (n = 289) and -1.7 kg (2%) in the attention control group (n = 273) (mean difference, -6.0 kg; 95% CI, -7.3 kg to -4.7 kg). There were 169 serious adverse events; none were definitely related to the study. There were 729 adverse events; 32 (4%) were definitely related to the study, including 10 body injuries (9 in diet and exercise; 1 in attention control), 7 muscle strains (6 in diet and exercise; 1 in attention control), and 6 trip/fall events (all 6 in diet and exercise).Conclusions and relevanceAmong patients with knee osteoarthritis and overweight or obesity, diet and exercise compared with an attention control led to a statistically significant but small difference in knee pain over 18 months. The magnitude of the difference in pain between groups is of uncertain clinical importance.Trial registrationClinicalTrials.gov Identifier: NCT02577549.

Dataset Information

Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Trial registration

Publications

Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial.

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