scholarly journals Autoregulated Heavy Slow Resistance Training Combined with Radial Shockwave Therapy for Plantar Heel Pain: Protocol for a Mixed Methods Pilot Randomised Controlled Trial

2020 ◽  
Author(s):  
Ian Burton
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Resistance Training ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Heel Pain ◽  
Shockwave Therapy ◽  
Plantar Heel Pain ◽  
Pilot Rct ◽  
Randomised Controlled

Background: Plantar heel pain (PHP) is considered a tendinopathy and it affects up to 10% of the population. Both heavy slow resistance training (HSRT) and extracorporeal shockwave therapy (ESWT) have shown effectiveness for treating PHP in isolation. However more comprehensive exercise protocols and progression methods are needed due to poor long-term outcomes, and better standardization of ESWT protocols are required. Autoregulation of resistance training involves self-selecting exercise dosage based on individual factors. Although autoregulation has proven effective for strength gains in athletes, it has not been investigated in tendinopathy. It is recommended that PHP not be treated by one treatment in isolation, with there being a need to investigate feasibility and effectiveness of combined treatments in PHP. Currently, no studies have investigated autoregulated HSRT combined with ESWT, despite their individual efficacy. The optimal treatment protocol for PHP is unknown, and there is a need to ascertain whether the addition of ESWT to autoregulated HSRT leads to better outcomes compared to either alone. Methods: A three-arm randomised controlled trial (RCT) comparing these groups would be the ideal way to investigate this question, with a pilot RCT testing trial procedures and process evaluation required prior to a definitive RCT. Patients expectations, feasibility and acceptability of combined ESWT and exercise for PHP also remain unknown. Therefore, the addition of qualitative interviews in a mixed methods pilot RCT would help ascertain acceptability and help explain the intervention outcomes.

scholarly journals Home-based exercise for people living with frailty and chronic kidney disease: A mixed-methods pilot randomised controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0251652
Author(s):  
Andrew C. Nixon ◽  
Theodoros M. Bampouras ◽  
Helen J. Gooch ◽  
Hannah M. L. Young ◽  
Kenneth W. Finlayson ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Kidney Disease ◽  
Usual Care ◽  
Controlled Trial ◽  
Pilot Randomised Controlled Trial ◽  
Home Based ◽  
Pilot Rct ◽  
Randomised Controlled

Background Frailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed to inform the design of a definitive RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD. Methods Participants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability. Results Six hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence. Conclusions This pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD. Trial registration ISRCTN87708989; https://clinicaltrials.gov/.

Habits-GDM mobile application in managing gestational diabetes in Singapore: A mixed-methods study (Preprint)

2020 ◽  
Author(s):  
Shilpa Surendran ◽  
Chang Siang Lim ◽  
Gerald Choon Huat Koh ◽  
Tong Wei Yew ◽  
E Shyong Tai ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Perceived Usefulness ◽  
Mixed Methods Study ◽  
Automatic Data ◽  
Glucose Testing ◽  
Randomised Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing in Singapore and the cost of providing traditional care for GDM is high. Mobile health (mHealth) applications may act as useful tools in the management of GDM. OBJECTIVE The objective of this mixed-methods study was to measure the usage behaviour and explore users’ perceived usefulness of the Habits-GDM application when managing GDM in a randomised controlled trial. METHODS We conducted a quantitative analysis of the application usage behaviour in 170 Habits-GDM application users and 14 semi-structured interviews with users from a randomised controlled trial. RESULTS The convenience of automatic data transfer of weight values to the Habits-GDM application helped users (116/170, 68%) log their weight at least once a week. However, when the application had usability challenges, users avoided using that feature, i.e. users logged only an average of less than one meal/week out of the recommended six meals/week. Of the usability challenges, many users (12/14, 85.7%) mentioned food items not worded in the commonly known way and limited ethnic food database as the primary barriers. Only half of the users (84/170, 49.4%) accessed the educational lessons, but many (9/14, 64%) identified the provision of always available, valuable health-related information as an advantage of the educational lessons. ‘Healthy eating’ and ‘Why exercise’ were the most (56/84, 66.67%) and least (38/84, 45.24%) frequently accessed educational lessons, respectively. Users (10/14, 71.4%) reported sending messages to the coach via the chat interface only when they faced logistic issues and 86.45% of all the coach messages were replies typed by the research coordinator in response to the logistics issues (i.e. a request for blood glucose testing strips and appointment confirmation) raised by the users. Healthcare professionals lack of access to the coach’s dashboard discouraged users from asking queries related to GDM via the e-coaching feature. CONCLUSIONS The findings suggest that mHealth application acts as a useful tool in managing GDM. Culturally sensitive mHealth applications with a provision for women to interact with healthcare professionals should be developed in cooperation with the users. CLINICALTRIAL Not applicable.

scholarly journals Acceptability and Feasibility of a 13-Week Pilot Randomised Controlled Trial Testing the Effects of Incremental Doses of Beetroot Juice in Overweight and Obese Older Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 769
Author(s):  
Abrar M Babateen ◽  
Oliver M Shannon ◽  
Gerard M O’Brien ◽  
Edward Okello ◽  
Anmar A Khan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Beetroot Juice ◽  
Obese Adults ◽  
Pilot Randomised Controlled Trial ◽  
Brain Functions ◽  
Linear Relationships ◽  
Trial Testing ◽  
Pilot Rct ◽  
Randomised Controlled

Nitrate-rich food can increase nitric oxide production and improve vascular and brain functions. This study examines the feasibility of a randomised controlled trial (RCT) testing the effects of prolonged consumption of different doses of dietary nitrate (NO3-) in the form of beetroot juice (BJ) in overweight and obese older participants. A single-blind, four-arm parallel pilot RCT was conducted in 62 overweight and obese (30.4 ± 4 kg/m2) older participants (mean ± standard deviation (SD), 66 ± 4 years). Participants were randomized to: (1) high-NO3- (HN: 2 × 70 mL BJ/day) (2) medium-NO3- (MN: 70 mL BJ/day), (3) low-NO3- (LN: 70 mL BJ on alternate days) or (4) Placebo (PL: 70 mL of NO3--depleted BJ on alternate days), for 13 weeks. Compliance was checked by a daily log of consumed BJ, NO3- intake, and by measuring NO3- and NO2- concentrations in plasma, saliva, and urine samples. Fifty participants completed the study. Self-reported compliance to the interventions was >90%. There were significant positive linear relationships between NO3- dose and the increase in plasma and urinary NO3- concentration (R2 = 0.71, P < 0.001 and R2 = 0.46 P < 0.001, respectively), but relationships between NO3- dose and changes in salivary NO3- and NO2- were non-linear (R2 = 0.35, P = 0.002 and R2 = 0.23, P = 0.007, respectively). The results confirm the feasibility of prolonged BJ supplementation in older overweight and obese adults.

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