scholarly journals Effect of hemodiafiltration on measured physical activity: primary results of the HDFIT randomized controlled trial

2020 ◽  
Author(s):  
Roberto Pecoits-Filho ◽  
John Larkin ◽  
Carlos Eduardo Poli-de-Figueiredo ◽  
Américo Lourenço Cuvello-Neto ◽  
Ana Beatriz Lesqueves Barra ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Treatment Effect ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Dialysis Patients ◽  
Clinical Patient ◽  
Randomized Controlled ◽  
Patient Reported

Abstract Background Dialysis patients are typically inactive and their physical activity (PA) decreases over time. Uremic toxicity has been suggested as a potential causal factor of low PA in dialysis patients. Post-dilution high-volume online hemodiafiltration (HDF) provides greater higher molecular weight removal and studies suggest better clinical/patient-reported outcomes compared with hemodialysis (HD). Methods HDFIT was a randomized controlled trial at 13 clinics in Brazil that aimed to investigate the effects of HDF on measured PA (step counts) as a primary outcome. Stable HD patients (vintage 3–24 months) were randomized to receive HDF or high-flux HD. Treatment effect of HDF on the primary outcome from baseline to 3 and 6 months was estimated using a linear mixed-effects model. Results We randomized 195 patients (HDF 97; HD 98) between August 2016 and October 2017. Despite the achievement of a high convective volume in the majority of sessions and a positive impact on solute removal, the treatment effect HDF on the primary outcome was +538 [95% confidence interval (CI) −330 to 1407] steps/24 h after dialysis compared with HD, and was not statistically significant. Despite a lack of statistical significance, the observed size of the treatment effect was modest and driven by steps taken between 1.5 and 24.0 h after dialysis, in particular between 20 and 24 h (+197 steps; 95% CI −95 to 488). Conclusions HDF did not have a statistically significant treatment effect on PA 24 h following dialysis, albeit effect sizes may be clinically meaningful and deserve further investigation.

scholarly journals Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

scholarly journals Determining the feasibility of a trial to evaluate the effectiveness of phototherapy versus placebo at reducing pain during physical activity for people with knee osteoarthritis: a pilot randomized controlled trial 

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Kyle Vader ◽  
Abey Bekele Abebe ◽  
Mulugeta Bayisa Chala ◽  
Kevin Varette ◽  
Jordan Miller
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Treatment Fidelity ◽  
Randomized Controlled ◽  
Link Type ◽  
Full Trial

Abstract Background Although practice guidelines recommend physical activity and exercise for the management of knee osteoarthritis, pain is a common barrier to participation. Phototherapy has been shown to reduce pain intensity for people with knee osteoarthritis, but it is unclear if it reduces pain during physical activity or contributes to improved rehabilitation outcomes. Objective The aim of this study is to assess the feasibility of performing a fully powered randomized controlled trial (RCT) comparing an active phototherapy intervention versus placebo on pain during physical activity for people with knee osteoarthritis. Methods A pilot RCT was conducted to test the feasibility of a trial comparing 8-sessions (4 weeks) of active phototherapy versus placebo. People were able to participate if they (1) were an English speaking adult (> 18 years of age), (2) had received a diagnosis of knee osteoarthritis from a physician, and (3) self-reported experiencing pain and disability related to their knee osteoarthritis for > 3 months. Primary outcomes were the feasibility of participant recruitment, retention, assessment procedures, and maintaining high treatment fidelity. Secondary outcomes piloted for a full trial included pain during physical activity (primary outcome of full trial); self-reported pain severity, physical function, stiffness, adherence to prescribed exercise, global rating of change, patient satisfaction, and adverse events; 6-min walk test; and pressure pain threshold. Results Twenty participants (4 men; 16 women) with knee osteoarthritis and a mean age of 63.95 (SD: 9.27) years were recruited over a 3-week period (6.7 participants per week). Fifteen out of 20 (75%) of participants completed the primary outcome assessment at 4 weeks and 19/20 (95%) of participants were retained and completed the final 16-week assessment. Overall, 89% of all assessment items were completed by participants across all time-points. Fifteen out of 20 participants (75%) completed all 8 treatment sessions. Treatment fidelity was 100% for all completed treatment sessions. No adverse events were reported by participants in either group. Conclusions Results suggest that the trial methodology and intervention are feasible for implementation in a fully powered randomized controlled trial to determine the effectiveness of phototherapy at reducing pain during physical activity for people with knee osteoarthritis. Trial registration ClinicalTrials.gov, NCT04234685, January 21, 2020–Retrospectively registered.

scholarly journals Treatment of Osteoarthritis with Autologous, micro fragmented Adipose Tissue: A study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background: Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro fragmented adipose tissue has been suggested to relieve symptoms.Methods/Design: The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grade 2 – 3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months, the Tegner activity score, treatment failure and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion: This trial is the first to investigate the efficacy of autologous, micro fragmented adipose tissue in a randomized controlled trial. The study uses the patient reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

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