Exercise and Osteoarthritis: Are We Stopping Too Early? Findings from the Clearwater Exercise Study

2006 ◽  
Vol 14 (2) ◽  
pp. 169-180 ◽  
Author(s):  
Frances V. Wilder ◽  
John P. Barrett ◽  
Edward J. Farina
Keyword(s):  
Clinical Trials ◽  
Knee Pain ◽  
Exercise Intervention ◽  
Pain Reduction ◽  
Optimal Length ◽  
Knee Oa ◽  
Pain Scores ◽  
Time Periods

The value of exercise for people with knee osteoarthritis (OA) receives continuing consideration. The optimal length of study follow-up time remains unclear. A group of individuals with knee OA participating in an exercise intervention was followed for 2 years. The authors quantified the change in knee-pain scores during Months 1–12 and during Months 13–24. Eleven individuals with radiographic knee OA and knee-pain scores of 2+ were evaluated. Pain scores were collected weekly from participants who exercised three times a week. Participants demonstrated pain reduction during both time periods. Pain reduction during Months 13–24, –10.7%, was slightly higher than pain reduction during Months 1–12, –7.8%. Among people with knee OA who exercise, these findings suggest that knee-pain amelioration continues beyond 12 months. Clinicians should consider encouraging long-term exercise programs for knee-OA patients. To best characterize the effect of exercise on knee pain, researchers designing clinical trials might want to lengthen the studies’ duration.

scholarly journals 292 USEFULNESS OF 7 DAY KNEE PAIN SCORES AMONG PEOPLE WITH MILD TO MODERATE KNEE OA PARTICIPATING IN CLINICAL TRIALS

2009 ◽  
Vol 17 ◽  
pp. S158
Author(s):  
M. Agaliotis ◽  
L. Nairn ◽  
M. Votrubec ◽  
M. Fransen
Keyword(s):  
Clinical Trials ◽  
Knee Pain ◽  
Knee Oa ◽  
Pain Scores

scholarly journals Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis

2021 ◽  
pp. 135245852110002
Author(s):  
Bruce AC Cree ◽  
Jeffrey A Cohen ◽  
Anthony T Reder ◽  
Davorka Tomic ◽  
Diego Silva ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Therapeutic Benefit ◽  
Disease Modifying Therapies ◽  
Long Term Follow Up ◽  
Post Hoc ◽  
Switch Group ◽  
Relevant Outcome

Background: Disease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI). Objective and Methods: Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5–1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo. Results: At 8 years’ follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%–43.1%) of assessed participants in the IFNβ-1a–fingolimod switch group and 41.9% (36.6%–47.6%) on continuous fingolimod experienced CDI; disability did not worsen in approximately 70%. Similar results were seen in the combined FREEDOMS population. Proportionally fewer TRANSFORMS participants achieved SDI in the IFNβ-1a–fingolimod switch group than on continuous fingolimod (5.4% [3.0%–9.5%] vs 14.2% [10.8%–18.4%], p = 0.01). Conclusion: CDI and SDI are outcomes of interest for clinical trials and for long-term follow-up of participants with RMS. Monitoring CDI and SDI in addition to disability worsening may facilitate understanding of the therapeutic benefit of RMS treatments.

Permacol Collagen Paste Injection for Treatment of Complex Cryptoglandular Anal Fistulas: An Observational Cohort Study With a 2-Year Follow-up

2018 ◽  
Vol 26 (2) ◽  
pp. 168-179 ◽  
Author(s):  
Michele Schiano di Visconte ◽  
Andrea Braini ◽  
Luana Moras ◽  
Luigi Brusciano ◽  
Ludovico Docimo ◽  
...  
Keyword(s):  
Anal Fistulas ◽  
Recurrent Fistula ◽  
Pain Scores ◽  
Significant Difference ◽  
Paste Extrusion ◽  
Observational Cohort ◽  
Grading Scale

Background. Permacol paste injection is a novel treatment approach for complex cryptoglandular anal fistulas. This study was performed to evaluate the long-term clinical outcomes of treatment with Permacol paste for complex cryptoglandular fistulas. Methods. Patients with primary or recurrent complex cryptoglandular anal fistulas treated with Permacol paste from 2014 to 2016 were retrospectively analyzed. Results. A total of 46 patients (median age, 41.3 years; 21 female) underwent Permacol paste injection; 20 patients (43%) had previously undergone failed fistula surgery. The patients had experienced anal fistula-related symptoms for a median of 10 weeks (range, 3-50 weeks). All patients had a draining seton in situ for a median of 10 weeks (range, 4-46 weeks). The median follow-up time was 24 months (range, 1-25 months). At the 1-month follow-up, 2 patients had paste extrusion and 2 had anal abscesses. The mean preoperative Continence Grading Scale score was 1.10 ± 1.40, and that at 3 months postoperatively was 1.13 ± 1.39 ( P = .322). There was a significant difference in the preoperative and the 1- and 3-month postoperative pain scores ( P < .001). At the 24-month follow-up, the healing rate was 50% (n = 23). A total of 19 patients (41%) with a recurrent fistula after failed Permacol paste injection required additional operative procedures. The satisfaction rate at the 2-year follow-up was 65%. Conclusion. Permacol paste injection is minimally invasive and technically easy to perform. It can be considered as a viable and reasonable option for the treatment of complex cryptoglandular anal fistulas in patients with fecal continence disorders.

scholarly journals Effect of self-regulatory behaviour change techniques and predictors of physical activity maintenance in cancer survivors: a 12-month follow-up of the Phys-Can RCT

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne-Sophie Mazzoni ◽  
Hannah L. Brooke ◽  
Sveinung Berntsen ◽  
Karin Nordin ◽  
Ingrid Demmelmaier
Keyword(s):  
Physical Activity ◽  
Cancer Survivors ◽  
Cancer Treatment ◽  
Tobacco Use ◽  
Exercise Intervention ◽  
Behaviour Change Techniques ◽  
Exercise Motivation ◽  
History Of

Abstract Background Current knowledge about the promotion of long-term physical activity (PA) maintenance in cancer survivors is limited. The aims of this study were to 1) determine the effect of self-regulatory BCTs on long-term PA maintenance, and 2) identify predictors of long-term PA maintenance in cancer survivors 12 months after participating in a six-month exercise intervention during cancer treatment. Methods In a multicentre study with a 2 × 2 factorial design, the Phys-Can RCT, 577 participants with curable breast, colorectal or prostate cancer and starting their cancer treatment, were randomized to high intensity exercise with or without self-regulatory behaviour change techniques (BCTs; e.g. goal-setting and self-monitoring) or low-to-moderate intensity exercise with or without self-regulatory BCTs. Participants’ level of PA was assessed at the end of the exercise intervention and 12 months later (i.e. 12-month follow-up), using a PA monitor and a PA diary. Participants were categorized as either maintainers (change in minutes/week of aerobic PA ≥ 0 and/or change in number of sessions/week of resistance training ≥0) or non-maintainers. Data on potential predictors were collected at baseline and at the end of the exercise intervention. Multiple logistic regression analyses were performed to answer both research questions. Results A total of 301 participants (52%) completed the data assessments. A main effect of BCTs on PA maintenance was found (OR = 1.80, 95%CI [1.05–3.08]) at 12-month follow-up. Participants reporting higher health-related quality-of-life (HRQoL) (OR = 1.03, 95%CI [1.00–1.06] and higher exercise motivation (OR = 1.02, 95%CI [1.00–1.04]) at baseline were more likely to maintain PA levels at 12-month follow-up. Participants with higher exercise expectations (OR = 0.88, 95%CI [0.78–0.99]) and a history of tobacco use at baseline (OR = 0.43, 95%CI [0.21–0.86]) were less likely to maintain PA levels at 12-month follow-up. Finally, participants with greater BMI increases over the course of the exercise intervention (OR = 0.63, 95%CI [0.44–0.90]) were less likely to maintain their PA levels at 12-month follow-up. Conclusions Self-regulatory BCTs improved PA maintenance at 12-month follow-up and can be recommended to cancer survivors for long-term PA maintenance. Such support should be considered especially for patients with low HRQoL, low exercise motivation, high exercise expectations or with a history of tobacco use at the start of their cancer treatment, as well as for those gaining weight during their treatment. However, more experimental studies are needed to investigate the efficacy of individual or combinations of BCTs in broader clinical populations. Trial registration NCT02473003 (10/10/2014).

scholarly journals The Effect of a Lower Body Positive Pressure Supported Treadmill Exercise Regime on Systemic Biomarkers of Inflammation and Cartilage Degradation in Individuals with Knee Osteoarthritis: A Pilot Study

2021 ◽  
Vol 9 (3) ◽  
pp. 18
Author(s):  
Stephen Cornish ◽  
Jason Peeler
Keyword(s):  
Articular Cartilage ◽  
Knee Pain ◽  
Weight Bearing ◽  
Cartilage Degradation ◽  
Treadmill Walking ◽  
Positive Pressure ◽  
Control Group ◽  
Knee Oa ◽  
And Cartilage

Background: Knee osteoarthritis (OA) has been linked to a chronic low-grade inflammatory response and altered metabolic activity of articular cartilage. Objective: The purpose of this investigation was to evaluate the effectiveness of a 12-week (3 times/week) lower body positive pressure (LBPP) treadmill walking regime on knee pain and systemic biomarkers of inflammation and cartilage degradation. Methods: Sixteen overweight (BMI > 25 kg/m2) knee OA patients were randomized to a LBPP treadmill walking exercise group (N = 7) or non-exercise control group (N = 9). Baseline and 12-week follow-up assessments evaluated the following dependent variables: acute knee pain during full weight bearing treadmill walking; inflammatory biomarkers (C-reactive protein, interleukin-1β, interleukin-6, s100A8/A9, and tumor necrosis factor-α), and catabolic metabolism of articular cartilage (sCOMP). Results: Knee pain at baseline and follow-up remained unchanged for the non-exercise control group (P > 0.05). However, knee pain for the LBPP exercise group was significantly decreased at follow-up (P ≤ 0.05). No differences in the biomarkers of inflammation and cartilage degradation were observed for between and within group comparisons (all P > 0.05). Conclusions: Data suggested that the LBPP supported walking regime could be effectively used to promote regular weight bearing exercise without exacerbation of knee joint pain and did not increase levels of systemic inflammation or catabolic activity of articular cartilage in overweight knee OA patients. This pilot investigation offers important insight regarding the potential role that the LBPP technology could play in facilitating investigations examining the disease modifying effect of exercise on knee OA pathogenesis.

Long-term effects of group exercise intervention on maximal step-up height in middle-aged female primary care patients with obesity and other cardio-metabolic risk factors

2020 ◽  
Author(s):  
Lillemor Amanda Nyberg ◽  
Carl Johan Sundberg ◽  
Per Wändell ◽  
Jan Kowalski ◽  
Mai-Lis Hellenius
Keyword(s):  
Physical Activity ◽  
Waist Circumference ◽  
Exercise Intervention ◽  
Metabolic Risk ◽  
Group Exercise ◽  
Long Term Effects ◽  
Sf 36 ◽  
Primary Care Patients

Abstract Background: Low physical performance is a predictor of morbidity and mortality. This study looks at long-term effects of an exercise intervention on maximal step-up height (MSH) in individuals with low physical function. Furthermore, we studied correlates to changes in MSH. Methods: Female patients (n=101), mean(SD) age of 52(11) years, were recruited for a 3-month group exercise intervention including 2-3 sessions/week of mixed aerobic fitness and strength training. MSH, weight, body mass index (BMI), waist circumference, maximal oxygen consumption (VO₂-max), self-reported health (SF-36) and physical activity (PA) were measured at baseline (T0), after 3 months (T1) and after 14-30(mean 22) months (T2). Relationships between changes in MSH (cm) and age, baseline MSH, time to follow-up, changes in anthropometric measurements, VO₂-max, SF-36 and PA were studied with regression analyses. Results: MSH, significantly, increased from T0 to T1, 27.2(5.7) to 29.0(5.5) cm and decreased to 25.2(5.5) cm at T2. Time to follow-up (B=-0.42, p<0.001) and change in BMI (B=-0.29, p=0.012) correlated significantly to changes in MSH. Waist circumference, VO₂-max, PF and exercise/physical activity levels were significantly improved at T2, while BMI did not change. In a univariate logistic regression model, maintenance of MSH correlated to the extent of mixed training (OR 3.33, 95% CI 1.25-8.89). In a multivariate logistic regression model adjusted for important factors the correlation was not significant. However, MSH was significantly higher in individuals participating in 2-3 session per week compared to one session. Conclusions: A 3-month group exercise intervention increased MSH, improved fitness, decreased risk in female patients with elevated cardio-metabolic risk. After an average of 22 months MSH was reduced while positive effects remained for waist circumference, VO₂-max, physical function and physical activity. However, regular group exercise 2-3 times per week with mixed aerobic fitness and strength training was associated with maintenance of MSH in a subgroup of patients. We suggest that such an intervention including regular support from healthcare professionals is a successful approach for maintaining improved leg-muscle strength among primary care patients.

scholarly journals Intergenerational monitoring in clinical trials of germline gene editing

2019 ◽  
Vol 46 (3) ◽  
pp. 183-187 ◽  
Author(s):  
Bryan Cwik
Keyword(s):  
Clinical Trials ◽  
Gene Editing ◽  
Ethical Issues ◽  
Human Subjects ◽  
Germline Gene ◽  
Ethical Challenges ◽  
Human Subjects Research ◽  
Follow Up Study

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

scholarly journals Colonoscopy at a Combined District General Hospital and Specialist Endoscopy Unit: Lessons from 505 Consecutive Examinations

2002 ◽  
Vol 95 (4) ◽  
pp. 194-197 ◽  
Author(s):  
Siwan Thomas-Gibson ◽  
Catherine Thapar ◽  
Syed G Shah ◽  
Brian P Saunders
Keyword(s):  
General Hospital ◽  
District General Hospital ◽  
British Society ◽  
Completion Rates ◽  
Endoscopy Unit ◽  
Pain Scores ◽  
Training And Supervision ◽  
Long Term Follow Up

Provisional reports from the Intercollegiate British Society of Gastroenterology National Colonoscopy audit show completion rates of 57–77%for the procedure and poor levels of training and supervision. We prospectively audited all aspects of colonoscopy performed at a combined district general hospital and specialist endoscopy unit. Details of referral, examination, endoscopist, complications and follow-up were recorded and patients were sent questionnaires for long-term follow-up. 505 patients (246 male) underwent colonoscopy by 27 different endoscopists. Their median age was 57 years (range 13–92) and 93%were outpatients. 64% patients were symptomatic and 36%were having surveillance or follow-up colonoscopy. The overall caecal intubation rate was 93%, with little difference between surgeons, physicians and experienced trainees (89%, 92%, 94%) and specialist endoscopists (98%). In only one case was an inexperienced trainee (<100 procedures) unsupervised. Pain scores estimated by the endoscopist were well matched with those given by the patient—medians 29 and 26 (maximum 100) respectively. Median satisfaction score was 96 (maximum 100). Polyp pick-up rate was 26.9%and there were 11 new cancers. 16 (3%) minor immediate complications were recorded—5 oversedation, 6 vasovagal attacks, 3 polypectomy haemorrhages and 2 mucosal injuries (neither requiring treatment). 3 patients died within 6 months of follow-up but no death was colonoscopy related. Completion rates in this setting were adequate for all endoscopists studied. Patient satisfaction with the procedure was high and very few immediate or long-term complications were encountered.

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