Systematic Monitoring and Treatment of Physical Symptoms to Alleviate Fatigue in Patients With Advanced Cancer: A Randomized Controlled Trial

2013 ◽  
Vol 31 (6) ◽  
pp. 716-723 ◽  
Author(s):  
Pleun J. de Raaf ◽  
Cora de Klerk ◽  
Reinier Timman ◽  
Jan J.V. Busschbach ◽  
Wendy H. Oldenmenger ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Effect Size ◽  
Randomized Clinical Trials ◽  
Rating Scale ◽  
Daily Life ◽  
Controlled Trial ◽  
Symptom Burden ◽  
Physical Symptoms ◽  
Significant Group ◽  
Over Time

Purpose Several guidelines on the treatment of cancer-related fatigue recommend optimizing treatment of accompanying symptoms. However, evidence for this recommendation from randomized clinical trials is lacking. We investigated whether monitoring and protocolized treatment of physical symptoms alleviates fatigue. Patients and Methods In all, 152 fatigued patients with advanced cancer were randomly assigned to protocolized patient-tailored treatment (PPT) of symptoms or care as usual. The PPT group had four appointments with a nurse who assessed nine symptoms on a 0 to 10 numeric rating scale (NRS). Patients received a nonpharmacologic intervention for symptoms with a score ≥ 1 and a medical intervention for symptoms with a score ≥ 4. Fatigue dimensions, fatigue NRS score, interference of fatigue with daily life, symptom burden, quality of life, anxiety, and depression were measured at baseline and after 1, 2, and 3 months. Differences between the groups over time were assessed by using mixed modeling. Results Seventy-six patients were randomly assigned to each study arm. Mean age was 58 ± 10 years, 57% were female, and 65% were given palliative chemotherapy. We found significant improvements over time in favor of PPT for the primary outcome general fatigue (P = .01), with significant group differences at month 1 (effect size, 0.26; P = .007) and month 2 (effect size, 0.35; P = .005). Improvements in favor of PPT were also found for the following secondary outcomes: fatigue dimensions “reduced activity” and “reduced motivation,” fatigue NRS, symptom burden, interference of fatigue with daily life, and anxiety (all P ≤ .03). Conclusion In fatigued patients with advanced cancer, nurse-led monitoring and protocolized treatment of physical symptoms is effective in alleviating fatigue.

Randomized clinical trial on cognitive therapy for depression in women with metastatic breast cancer: Psychological and immunological effects

2006 ◽  
Vol 4 (3) ◽  
pp. 219-237 ◽  
Author(s):  
JOSÉE SAVARD ◽  
SÉBASTIEN SIMARD ◽  
ISABELLE GIGUÈRE ◽  
HANS IVERS ◽  
CHARLES M. MORIN ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cognitive Therapy ◽  
Advanced Cancer ◽  
Rating Scale ◽  
Controlled Trial ◽  
Metastatic Breast ◽  
Empirically Supported Treatment ◽  
Booster Sessions ◽  
Over Time

Objective:Depression is particularly prevalent in patients with advanced cancer. Cognitive therapy (CT) is an empirically supported treatment for depression in the general population. However, efficacy remains to be demonstrated in patients with advanced cancer. A prior controlled trial of CT in a group format showed improvements in depression, mood disturbance, and self-esteem; however, these effects were not maintained over time. Studies examining the efficacy of individual format CT interventions that may ensure more long-term maintenance of benefits are necessary. This study assessed the efficacy of CT for depression administered individually in women with metastatic breast cancer and its effect on immune function.Method: Forty-five women were randomly assigned to either individual CT or to a waiting-list control (WLC) condition. CT was composed of eight weekly sessions of CT and three booster sessions administered at 3-week intervals following the end of treatment.Results: Patients treated with CT had significantly lower scores on the Hamilton Depression Rating Scale at posttreatment compared to untreated patients. Pooled data from both groups indicated significant reductions of depressive symptoms from pre- to posttreatment, as well as reduction of associated symptoms including anxiety, fatigue, and insomnia symptoms. These effects were well sustained at the 3- and 6-month follow-up evaluations. CT for depression did not appear to have a significant impact on immune functioning.Significance of results: Findings of this study support the efficacy of CT for depression in this population and suggest that the administration of individual and booster sessions after treatment termination may be instrumental in sustaining the treatment effects over time.

Evolution of the randomized controlled trial (RCT) in oncology over three decades

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6515-6515 ◽  
Author(s):  
C. M. Booth ◽  
D. W. Cescon ◽  
L. Wang ◽  
I. F. Tannock ◽  
M. K. Krzyzanowska
Keyword(s):  
Primary Endpoint ◽  
Effect Size ◽  
Response Rate ◽  
Controlled Trial ◽  
For Profit ◽  
Survival Endpoints ◽  
Trends Over Time ◽  
And Control ◽  
Median Rate ◽  
Over Time

6515 Background: The RCT is the gold standard for establishing new therapies in oncology. Here we document changes with time in design, results, author conclusions and sponsorship. Methods: Reports of RCTs evaluating systemic therapy for breast, colorectal (CRC) and non-small cell lung cancer (NSCLC) published 1975–2004 in 6 major journals were reviewed. Two authors independently abstracted data regarding trial design, effect size and author conclusions. Author conclusions were assigned a score from 1 to 7: 4/7 for a neutral statement, 7/7 and 1/7 for strong endorsement of experimental and control arm respectively. For each study the effect size for the primary endpoint was converted to a summary measure: hazard ratio [HR] for survival endpoints and relative risk [RR] for response rate. Descriptive statistics were used to analyze trends over time. Results: 326 eligible RCTs were included (48% breast, 24% CRC, 28% NSCLC). There was a significant increase in the number and size of RCTs (see Table ). Median rate of accrual increased from 7 patients/month in 1975–84 to 14 patients/month in 1995–2004 (p<0.001). There was an increase in multicenter (55 to 95%, p<0.001), international trials (26 to 52%, p<0.001) and for-profit sponsorship over time (6 to 57%, p<0.001). There was increasing use of survival (13 to 48%,) and decreasing use of response rate (32 to 14%) as primary endpoint (p<0.001). Authors have become more likely to strongly endorse the experimental arm despite no change in effect size over time (p=0.005). Studies sponsored by for-profit organizations were more likely to strongly endorse the experimental agent than studies not sponsored by for-profit groups (median author score 6/7 vs. 4/7, p<0.001). Conclusions: RCTs in oncology have become more common, larger, and are more likely to be sponsored by industry. Authors of modern RCTs are more likely to strongly endorse novel therapies despite no increase in the relative benefit of interventions. For-profit sponsorship is associated with stronger endorsement of the experimental arm. No significant financial relationships to disclose. [Table: see text]

Symptom burden in hospitalized patients with advanced cancer.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 100-100 ◽  
Author(s):  
Samantha M.C. Moran ◽  
Areej El-Jawahri ◽  
William F. Pirl ◽  
Lara Traeger ◽  
Pallavi Kumar ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Hospital Admissions ◽  
Psychological Symptoms ◽  
Massachusetts General Hospital ◽  
Symptom Burden ◽  
Hematologic Malignancies ◽  
Psychological Needs ◽  
Physical Symptoms ◽  
Hospitalized Patients ◽  
Assessment System

100 Background: Patients with advanced cancer experience high rates of both physical and psychological morbidity, but data describing patients’ symptoms during hospital admissions are lacking. We sought to describe symptom burden in hospitalized patients with incurable solid and hematologic malignancies. Methods: We prospectively enrolled patients with incurable cancers admitted to the Massachusetts General Hospital from 9/1/2014 through 5/1/2015. Within the first week of their admission, we assessed physical and psychological symptoms using the Edmonton Symptom Assessment System-revised (ESAS-r). Beginning 11/15/2015, we also administered the Patient Health Questionnaire 4 (PHQ-4), scored categorically. Results: We enrolled 457 of 547 (84%) eligible patients. Participants (mean age=63.8 years; n=231, 51% female) had the following malignancies: gastrointestinal (n=149, 33%), lung (n=77, 17%), genitourinary (n=52, 11%), breast (n=33, 7%), hematologic (n=24, 5%), and other solid tumors (n=122, 27%). Using the ESAS-r, tiredness, drowsiness, anorexia, and pain were the most common severe symptoms. Using the PHQ-4, approximately one-third of participants screened positive for depression (91/271, 34%) and anxiety (86/273, 32%). Conclusions: Hospitalized patients with incurable solid and hematologic malignancies experience substantial physical and psychological symptoms. Most patients reported at least moderate tiredness, drowsiness, anorexia and pain. Additionally, a concerning proportion reported depression and anxiety. Our data demonstrate the need for efforts to alleviate the physical symptoms experienced by this population, while also seeking to understand and address their psychological needs. [Table: see text]

scholarly journals Levetiracetam as an Adjunctive Treatment for Mania: A Double-Blind, Randomized, Placebo-Controlled Trial

2022 ◽  
pp. 1-12
Author(s):  
Amir Keshavarzi ◽  
Aziz Sharifi ◽  
Leila Jahangard ◽  
Alireza Soltanian ◽  
Annette Beatrix Brühl ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Cognitive Performance ◽  
Effect Size ◽  
Rating Scale ◽  
Medium Effect ◽  
Large Effect Size ◽  
Placebo Condition ◽  
Double Blind ◽  
Subjective Sleep ◽  
Over Time

<b><i>Background:</i></b> Levetiracetam is an anticonvulsant with a low side effect profile and favorable properties for individuals with bipolar I disorder during their manic phase. Despite initial promising results until about 2008, it appears that this track of research has not been followed-up. To counter this, we tested the influence of adjuvant levetiracetam on acute mania, compared to placebo. More specifically, we performed a randomized, double-blind, placebo-controlled clinical trial among inpatients with bipolar disorder I during their acute phase of mania. <b><i>Methods:</i></b> A total of 72 inpatients (mean age: 33.98 years; 23.6% females) with diagnosed bipolar disorder I and during their acute manic phase were randomly assigned either to the adjuvant levetiracetam (250 mg to a maximum of 1,500 mg) or to the placebo condition. Standard medication was lithium at therapeutic dosages. At baseline, participants completed a series of self-rating questionnaires covering sociodemographic information and subjective sleep. Subjective sleep was re-assessed 24 days later at the end of the study. Experts rated participants’ acute state of mania with the Young Mania Rating Scale at baseline and at day 12 and day 24. Participants’ cognitive performance was assessed at baseline and at day 24 at the end of the study. <b><i>Results:</i></b> Over time, mania scores significantly decreased (large effect size), but more so in the levetiracetam condition, compared to the placebo condition (medium effect size). Likewise, over time, subjective sleep improved (large effect size), but more so in the levetiracetam condition, compared to the placebo condition (large effect size). Over time, cognitive performance improved (large effect size), irrespective of the study condition. <b><i>Conclusions:</i></b> Compared to placebo, adjuvant levetiracetam to lithium improved symptoms of mania, as rated by experts, and subjective sleep quality. Adjuvant levetiracetam had no further favorable (or detrimental) impact on cognitive performance.

Early Palliative Care for Patients with Advanced Cancer (DRAFT)

2018 ◽  
Author(s):  
David Hui
Keyword(s):  
Palliative Care ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Symptom Burden ◽  
Early Palliative Care ◽  
Key Points ◽  
Oncology Care ◽  
Cluster Randomized ◽  
Study Intervention

This chapter discusses the Zimmermann trial, a large partially blinded, cluster randomized controlled trial of routine oncology care with or without early routine referral to palliative care. This landmark study found that early palliative care involvement was associated with improved quality of life, symptom burden and satisfaction among patients with advanced cancer. This chapter describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case to illustrate some key points around palliative care referral.

Post-discharge transitions of care for hospitalized patients with advanced cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6504-6504
Author(s):  
Daniel E Lage ◽  
Ryan David Nipp ◽  
Sara D'Arpino ◽  
Samantha M.C. Moran ◽  
Ephraim P. Hochberg ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Acute Care ◽  
Advanced Cancer ◽  
Regression Models ◽  
Symptom Burden ◽  
Physical Symptoms ◽  
Transitions Of Care ◽  
Depression Symptoms ◽  
Post Discharge ◽  
Discharge Location

6504 Background: Patients with advanced cancer experience frequent hospitalizations and burdensome transitions of care post-discharge. We examined predictors of discharge location for patients with advanced cancer. Methods: We prospectively enrolled patients with advanced cancer with unplanned hospitalizations from 9/14 to 3/16. Upon admission, we used the Edmonton Symptom Assessment Scale and Patient Health Questionnaire-4 to assess physical and psychological symptoms, respectively. We used logistic regression models to identify predictors of discharge to location other than home, including post-acute care (PAC) [skilled nursing facility or long term acute care hospital] or hospice [any setting]. We used Cox regression models adjusted for clinical variables to assess the relationship between discharge location and survival. Results: Out of 932 patients, 726 (77.9%) were discharged home, 118 (12.7%) to PAC and 88 (9.4%) to hospice. Compared with patients discharged home, those discharged to PAC or hospice had higher symptom burden, including dyspnea, constipation, low appetite, drowsiness, fatigue, depression, and anxiety (all p < 0.05). Patients discharged to PAC or hospice vs. home were more likely to be older (OR 1.03, p < 0.0001), live alone (OR 1.95, 95% CI: 1.25-3.02, p < 0.003), have impaired mobility (OR 5.08, 95% CI: 3.46-7.45, p < 0.0001), longer length of stay (OR 1.15, 95% CI: 1.11-1.20, p < 0.0001), higher ESAS physical symptoms (OR 1.02, 95% CI: 1.003-1.032, p < 0.017), and higher PHQ-2 depression symptoms (OR 1.13, 95% CI: 1.01-1.25, p < 0.027). Patients discharged to hospice vs. PAC were more likely to receive palliative care consultation (OR 4.44, 95% CI: 2.12 to 9.29, p < 0.0001) and have shorter length of stay (OR 0.84, 95% CI: 0.77 to 0.91, p < 0.0001). Compared with patients discharged home, those discharged to PAC had lower survival (HR 1.53, 95% CI 1.22-1.93, p < 0.0001). Conclusions: Patients with advanced cancer discharged to PAC or hospice have substantial physical and psychological symptom burden and poor physical function. Patients discharged to PAC also have inferior survival compared with those discharged home. They may benefit from targeted interventions to improve their quality of life and care.

Efficacy and side effect profile of olanzapine versus haloperidol for symptoms of delirium in hospitalized patients with advanced cancer: A multicenter, investigator-blinded, randomized, controlled trial (RCT).

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 231-231
Author(s):  
Maurice Van Der Vorst ◽  
Elisabeth C.W. Neefjes ◽  
Manon S.A. Boddaert ◽  
Bertha A.T.T. Verdegaal ◽  
Aart Beeker ◽  
...  
Keyword(s):  
Side Effects ◽  
Advanced Cancer ◽  
Side Effect ◽  
Rating Scale ◽  
Controlled Trial ◽  
Hospitalized Patients ◽  
Phase Iii ◽  
Side Effect Profile ◽  
Advanced Cancer Patients ◽  
Grade 3

231 Background: Delirium is highly prevalent in patients with advanced cancer. Patients experiencing delirium may require pharmacological treatment to reduce distressing symptoms. Atypical antipsychotics, like olanzapine, are potentially safer and more effective than haloperidol, but no phase III RCTs are reported in patients with advanced cancer. Methods: Hospitalized patients with advanced cancer diagnosed with delirium ( DSM-IV-TR criteria) were randomly assigned centrally (1:1) to olanzapine or haloperidol. Dosages were up-titrated. Primary endpoint was delirium resolution rate (DRR), defined as Delirium Rating Scale-Revised-98 (DRS-R-98) total severity score < 15.25 points and ≥ 4.5 points reduction. Secondary endpoints: time to recovery, grade ≥ 3 side effects (Common Terminology Criteria for Adverse Events version 3.0), and distress (Delirium Experience Questionnaire). The study was powered to increase DRR with 25% for olanzapine compared to haloperidol. Results: Between January 2010 and June 2016, 100 of the anticipated 200 patients were enrolled in the study from 6 sites in the Netherlands and randomly assigned to olanzapine (n = 50) or haloperidol (n = 50). Baseline characteristics were well balanced. Interim analysis showed a difference in DRR of -12.2% (95% confidence interval (CI) = -32.0%- 7.4%); 45% for olanzapine (95% CI 31.0-58.8) vs 57% for haloperidol (95% CI 43.3-71.0), P = 0.22).Time to recovery was 4.5 days in the olanzapine arm vs 2.8 days in the haloperidol arm (P = 0.20). There was no difference in grade ≥ 3 side effects between both arms (OR 0.44, 95% CI 0.14-1.40; P = 0.16). Mean level of distress in patients was 2.1 (SD 1.4) for olanzapine vs 2.3 (SD 1.4) for haloperidol (P = 0.80). Formal interim futility analysis indicated a conditional power of 0.086, implying a very low likelihood (8.6%) of reaching the expected DRR superiority rate of 25% for olanzapine. Therefore, the study was prematurely terminated. Conclusions: No difference in efficacy and side effect profile was observed between haloperidol or olanzapine treatment for delirium in patients with advanced cancer. Clinical trial information: NCT01539733.

OS10.4.A The effects of SmartCare on neuro-oncology family caregivers’ distress: a randomized controlled trial

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii13-ii13
Author(s):  
F W Boele ◽  
J M Weimer ◽  
J Proudfoot ◽  
A L Marsland ◽  
T S Armstrong ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Family Caregivers ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Symptom Burden ◽  
Significant Group ◽  
Intention To Treat ◽  
Secondary Outcomes ◽  
Physical Consequences

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. MATERIAL AND METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

Adjunctive minocycline treatment for major depressive disorder: A proof of concept trial

2017 ◽  
Vol 51 (8) ◽  
pp. 829-840 ◽  
Author(s):  
Olivia M Dean ◽  
Buranee Kanchanatawan ◽  
Melanie Ashton ◽  
Mohammadreza Mohebbi ◽  
Chee Hong Ng ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Major Depressive Disorder ◽  
Confidence Interval ◽  
Depressive Disorder ◽  
Clinical Global Impression ◽  
Effect Size ◽  
Rating Scale ◽  
Controlled Trial ◽  
Major Depressive

Objective: Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. Methods: A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders–Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery–Asberg Depression Rating Scale (primary outcome), Clinical Global Impression–Improvement and Clinical Global Impression–Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Results: Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery–Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression–Improvement score – effect size (95% confidence interval) = −0.62 [−1.8, −0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score – effect size (confidence interval) = −0.12 [0.0, 0.2], p < 0.001; and Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool score – 0.79 [−4.5, −1.4], p < 0.001. These effects remained at follow-up (week 16), and Patient Global Impression also became significant, effect size (confidence interval) = 0.57 [−1.7, −0.4], p = 0.017. Conclusion: While the primary outcome was not significant, the improvements in other comprehensive clinical measures suggest that minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with major depressive disorder. Further studies are warranted to confirm the potential of this accessible agent to optimise treatment outcomes.

scholarly journals Progressive Resistance Training Improves Overall Physical Activity Levels in Patients With Early Osteoarthritis of the Knee: A Randomized Controlled Trial

2010 ◽  
Vol 90 (3) ◽  
pp. 356-366 ◽  
Author(s):  
Joshua N. Farr ◽  
Scott B. Going ◽  
Patrick E. McKnight ◽  
Shelley Kasle ◽  
Ellen C. Cussler ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Resistance Training ◽  
Effect Size ◽  
Early Onset ◽  
Controlled Trial ◽  
Significant Group ◽  
Knee Oa ◽  
Randomized Controlled ◽  
To Receive

Background Prescription of resistance training (RT) exercises is an essential aspect of management for knee osteoarthritis (OA). However, whether patients with knee OA who are randomly assigned to receive RT simply substitute RT for other modes of physical activity remains unclear. Objective The aim of this study was to determine the effect of a structured RT intervention on overall levels of moderate- and vigorous-intensity physical activity (MVPA) in patients with early-onset knee OA. The study compared patients with early-onset OA who participated in an RT program, those who participated in a self-management (SM) program, and those who participated in both RT and SM. Because participants randomly assigned to receive the RT intervention may simply switch activity modes, resulting in little net effect, we assessed total MVPA in addition to tracking changes in strength (force-generating capacity). Design and Intervention This study was a randomized controlled trial comparing the effectiveness of SM alone, RT alone, and combined RT+SM on MVPA in patients with early OA of the knee. Setting The study was conducted on a university campus, with patient recruitment from the local community. Participants The participants in this study were 171 patients (74% women, 26% men) with knee OA. They had a mean age of 55.1 (SD=7.1) years, a mean body mass index of 27.6 (SD=4.2) kg/m2, and radiographic status of grade II OA (and no higher) in at least one knee, as defined by the Kellgren and Lawrence classification. They wore an accelerometer while awake (X̄=14.2 [SD=2.2] hours) for 5 to 7 contiguous days (X̄=6.8 [SD=0.5] days) at baseline and at 3 and 9 months of intervention. Results The participants engaged in MVPA a mean of 26.2 (SD=19.3) minutes per day at baseline. Both groups significantly increased their MVPA from baseline to 3 months (RT group by 18% [effect size (d)=0.26]; SM group by 22% [effect size (d)=0.25]), but only the RT group sustained those changes at 9 months (RT group maintained a 10% increase [effect size (d)=0.15]; SM group maintained a 2% increase [effect size (d)=0.03]). A significant group × time interaction for MVPA indicated that the RT group maintained higher MVPA levels than the SM group. Limitations Lack of direct measures of energy expenditure and physical function was a limitation of the study. Conclusions Patients with early-onset OA of the knee can engage in an RT program without sacrificing their overall MVPA levels. These results support the value of RT for management of knee OA.

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