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Supervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and frequency. However, no guidance is offered regarding exercise training intensity. This study aims to compare the effects of 12-week-long supervised walking exercise training (high-intensity interval training (HIIT) vs moderate-intensity exercise (MOD)) in patients with chronic symptomatic PAD.
This study is a monocentric, interventional, non-blinded randomised controlled trial. 60 patients (30 in each group) will be randomly allocated (by using the random permuted blocks) to 12 weeks (three times a week) of HIIT or MOD. For HIIT, exercise sessions will consist of alternating brief high-intensity (≥85% of the peak heart rate (HRpeak)) periods (≤60 s) of work with periods of passive rest. Patients will be asked to complete 1 and then 2 sets of 5–7 (progressing to 10–15x60 s) walking intervals. For the MOD group, exercise training sessions will consist of an alternation of periods of work performed at moderate intensity (≤76% HRpeak) and periods of passive rest. Interventions will be matched by training load. The primary outcome will be the maximal walking distance. Secondary outcomes will include functional performance, functional capacity, heath-related quality of life, self-perceived walking abilities, physical activity and haemodynamic parameters.
The Angiof-HIIT Study was approved by the Human Research Ethics Committee of the Canton de Vaud (study number: 2022-01752). Written consent is mandatory prior to enrolment and randomisation. The results will be disseminated via national and international scientific meetings, scientific peer-reviewed journals and social media.
In Tokyo 2020 Paralympic Games, there were the rule and goal size changes at the blind football competition. This study aimed to compare the scoring and head impact characteristics during blind football competition between the Rio 2016 and Tokyo 2020 Paralympic Games using the official videos.
Video-based observational study.
In total, 36 blind football (men’s football 5-a-side) game videos were obtained from the official International Paralympic Committee.
Head impact was defined as the sudden contact of any object with the head. Videos were analysed to assess the number of scores and head impacts along with their corresponding details (ie, round, playing phase, scoring situation, impact situation, occurrence area, impact object, head impact site, fall and foul).
The total number of goals scored at the Tokyo 2020 Paralympic Games was nearly double that at the Rio 2016 Paralympic Games. Regarding head impacts, a total of 2036 cases (Rio 2016, n=1105; Tokyo 2020, n=931) were evaluated. Significant differences were observed in head impact characteristics between the Rio 2016 and Tokyo 2020 Paralympic Games among seven outcomes (round, scoring situation, impact situation, occurrence area, impact object, site of head impact and fall).
Compared with the Rio 2016 Paralympic Games, the Tokyo 2020 Paralympic Games showed an increase in the number of points scored and different head impact characteristics.
Breast cancer survivors (BCSs) are often faced with multiple mental and physical sequelae and are at increased risk of emotional distress, degraded health-related quality of life (HRQoL), chronic pain and fatigue.
Physical activity is strongly associated with improved HRQoL and survival rates; however, adherence rates to recommendations for a healthy lifestyle are seldom satisfactory among BCSs. Also, few studies have examined the effectiveness of multicomponent and personalised interventions that integrate physical activity and motivational techniques to improve the HRQoL of BCS.
"Activité physique adaptée Doublée d’un Accompagnement d’après cancer" (ADA) is an integrated programme of physical activity enriched with a dietary and supportive care approach targeting BCS in the early post-treatment phase. The effectiveness of the ADA intervention will be evaluated using a cluster randomised controlled trial design with two arms (ADA programme vs usual care; 1:1 ratio).
The ADA intervention aims to recruit 160 participants and will be implemented by Siel Bleu, a non-profit association specialised in health prevention via adapted physical activity. Measurements will be performed at baseline, 3, 6 and 12 months after the start of the intervention. The primary outcome will be participants’ HRQoL, at 12 months measured by the Functional Assessment of Chronic Illness Therapy-Fatigue global score. Secondary outcome will include participants’ physical, social, emotional and functional well-being. The effect of the intervention on physical activity level, motivation for physical activity, relation to food and self-efficacy will also be evaluated.
The study was approved by the ‘CPP Paris XI’ Institutional Review Board on 5 May 2022 (Ref no.: 21.04512.000048-22004). The study’s findings will be shared through various channels, including academic publications, simplified reports for wider audiences and active engagement with medical and institutional organisations as well as patients’ associations.
Knee osteoarthritis (KOA) is still a challenging degenerative joint disease with high morbidity and disease burden. Early-stage KOA, the focus of this study, could present a Window of Opportunity to arrest the disease process and reduce the disease burden. Yijinjing exercise is an important part of physical and psychological therapies in Traditional Chinese Exercise and may be an effective treatment. However, there is no clinical efficacy assessment of Yijinjing exercise for patients with early-stage KOA. Therefore, we designed a randomised controlled trial to evaluate the effectiveness of Yijinjing exercise on patients with early-stage KOA.
This is a parallel-design, two-arm, analyst assessor-blinded, randomised controlled trial. In total, 60 patients with early-stage KOA will be recruited and randomly assigned to the Yijinjing exercise group (n=30) and health education group (n=30) at a ratio of 1:1, receiving 12 weeks of Yijinjing exercise or health education accordingly. The primary outcome will be measured with the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes will include the Visual Analogue Scale, Short-Form 36 Item Health Survey Questionnaire, Beck Depression Inventory, Perceived Stress Scale, Berg Balance Scale, and Gait Analysis for a comprehensive assessment. Outcome measures are collected at baseline, at 12 week ending intervention and at the 12 week, 24 week and 48 week ending follow-up. The primay time point will be 12 weeks postintervention. Adverse events will be recorded for safety assessment.
This study has been approved by the ethical application of the Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee (2021SHL-KY-78).
ChiCTR2200065178
Older adults constitute a heterogeneous group, and the focus of the individual physical exercise is often subject to the reasoning and experience of health professionals or exercise physiologists who prescribe them. Thus, this is the first effort to explicitly conceptualise the planning of individualised physical exercise training (
The concept of
Outpatient setting.
We included 115 older adults (70 females) from an outpatient setting with a median age of 74 years.
Health indicators assessing aerobic capacity, strength, balance and musculoskeletal pain/discomfort sites were collected and informed the concept of
We included 115 older adults (70 females) from an outpatient setting median age of 74 years. Approximately two-thirds of participants exceeded at least one health indicator cut-point for aerobic training. One-third of the participants exceeded the cut-point for upper extremity strength, and almost all participants >99% exceeded the cut-point for lower extremity strength. Approximately two-thirds of the participants exceeded the cut-point for functional/balance training. The most prevalent site of musculoskeletal pain was the lower extremities. Eight of 20 training combinations were used, clustering the 115 participants primarily in three main training combinations.
This study shows that older adults vary in physical functioning, indicating that exercise preferences and rehabilitation needs are individual.
Traumatic shoulder dislocation is a common shoulder injury, especially among the young and active population. More than 95% of dislocations are anterior, in which the humeral head is forced beyond the anterior glenoid rim. The injury leads to increased joint laxity and recurrence rates are high. There is evidence that the shoulder biomechanics and neuromuscular control change following dislocation, but the existing literature is scarce, and it remains to be established if and how these parameters are useful in the clinical setting. The aim of this exploratory prospective cohort study is to investigate biomechanical and neuromuscular outcomes in patients with traumatic anterior shoulder instability undergoing arthroscopic Bankart repair, to test the hypothesis that examinations of these characteristics are applicable in the clinical setting to assess shoulder instability.
This is a prospective multicentre cohort study with repeated measures of 30 patients undergoing arthroscopic Bankart repair. With carefully selected and completely non-invasive examination methods, we will investigate biomechanical and neuromuscular outcomes in the affected shoulders once presurgically and twice post surgically at 6 and 12 months. Patients’ contralateral shoulders are investigated once to establish a preinjury level.
The study was approved by the Capital Region Ethics Committee (journal-no: H-21027799) and the Capital Region Knowledge Center for Data Reviews (journal-no: P-2021-842) before patient recruitment began. The study results will be published in international peer-reviewed journals, online and in other relevant media, presented at medical conventions and disseminated to clinicians and patients as appropriate.
Cardiac rehabilitation (CR) can reduce cardiovascular mortality and improve health-related quality of life. In the United Kingdom, patient uptake of CR remains low (52%), falling well short of the target in the 2019 National Health Service long-term plan (85%). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and physical activity advice, enabling patients to engage in regular long-term physically active lifestyles. This randomised controlled trial (RCT) will evaluate the feasibility of mHealth technology when incorporated into a structured home-based walking intervention, in people with recent myocardial infarction.
This is a feasibility, assessor blinded, parallel group RCT. Participants will be allocated to either CR standard care (control group) or CR standard care+mHealth supported exercise counselling (mHealth intervention group). Feasibility outcomes will include the number of patients approached, screened and eligible; the percentage of patients who decline CR (including reasons for declining), agree to CR and consent to being part of the study; the percentage of patients who enrol in standard CR and reasons for drop out; and the percentage of participants who complete clinical, physical and psychosocial outcomes to identify a suitable primary outcome for a future definitive trial.
The trial was approved in the UK by the Northwest—Greater Manchester East Research Ethics Committee (22/NW/0301) and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings.
Frailty is one of the most common comorbidities in kidney transplant recipients (KTRs). Physical, psychological and social frailty could be improved by exercise intervention. Baduanjin, also known as Eight-section Brocades, is a type of traditional Chinese medicine exercise characterised by the interplay between physical postures and movements, breathing and mind. It can help frail patients strengthen their upper and lower body muscles, improve their mood, quality of life and frailty. However, the effectiveness of Baduanjin on frail KTRs remains unknown. Therefore, we will conduct a randomised controlled trial (RCT) to evaluate the effectiveness of Baduanjin on frail KTRs.
This protocol describes an assessor and analyst blinded, parallel RCT for frail KTRs comparing Baduanjin group (n=72) with care-as-usual group (n=72). The primary outcomes are frailty assessed by Frailty Phenotype scale and Tilburg Frailty Indicator scale, and muscle strength assessed by a grip strength metre. The secondary outcomes are quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (MOS SF-36) and depression assessed by the Hospital Anxiety and Depression Scale. All these data will be collected at the baseline, after 3, 6, 9 and 12 months, respectively. Two-way mixed analysis of variance (ANOVA) will be used to test the effectiveness of Baduanjin exercise. Qualitative interviews with participants in the intervention group will also be performed after 6 months. Themes will be extracted from interview transcripts using NVivo software.
The Ethics Committees of Beijing University of Chinese Medicine (2022BZYLL1018) and China-Japan Friendship Hospital (2022-KY-250) had approved the study. The organ donors were all from China-Japan Friendship Hospital. They provided informed consent and they were not executed prisoners. We have provided BMJ Open with documentation from the hospital that indicates that the organs will be harvested ethically. The findings of this study will be disseminated through peer-reviewed journals, international conferences, media reports and briefings.
ChiCTR2100041730
Chronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors; thus, treatments to reduce symptoms are important to improve the quality of life of this population. We aimed to evaluate the effects of transcranial direct current stimulation (tDCS) combined with Pilates-based exercises compared with sham stimulation on pain, quality of life and disability in patients with chronic non-specific low back pain.
This is a protocol for a double-blind randomised controlled trial with participants, outcome assessor and statistician blinded. We will include 36 individuals with a history of non-specific chronic low back pain for more than 12 weeks and minimum pain intensity of 3 points on the Numerical Pain Rating Scale. Individuals will be randomised into two groups: (1) active tDCS combined with Pilates-based exercises and (2) sham tDCS combined with Pilates-based exercises. Three weekly sessions of the protocol will be provided for 4 weeks, and individuals will be submitted to three assessments: the first (T0) will be performed before the intervention protocol, the second (T1) immediately after the intervention protocol and the third (T2) will be a follow-up 1 month after the end of the intervention. We will assess pain, disability, central sensitisation, quality of life, pressure pain threshold, global impression of change, adverse events and medication use. The Numerical Pain Rating Scale and the Roland-Morris Disability Questionnaire will be used at T1 to assess pain and disability, respectively, as primary outcome measures.
This trial was prospectively registered in ClinicalTrials.gov website and ethically approved by the Ethics and Research Committee of the Faculty of Health Sciences of Trairi (report number: 5.411.244) before data collection. We will publish the results in a peer-reviewed medical journal and on institution websites.
ClinicalTrials.gov (NCT05467566).
Anterior cruciate ligament (ACL) rupture is one of the most common knee injuries in sports, and the gold standard for treating ACL rupture is tendon graft reconstruction. Internal brace technology is being used nowadays for ligament repair; however, more relevant in vivo clinical evidence is required for using internal brace technology in ACL reconstruction (ACLR). We conducted a randomised controlled trial to investigate the clinical efficacy of internal brace technology in ACLR.
This randomised, parallel-controlled trial included patients with ACL rupture who underwent inpatient surgery at the Department of Orthopaedics, Xiangya Hospital, Central South University. Random number table method was used to assign the participants to either the test or the control group. The test group underwent ACLR using the internal brace technique, whereas the control group underwent standard ACLR. Uniform postoperative rehabilitation protocol was used for both the groups. Patient-reported outcomes included preoperative baseline and postoperative recovery at 1, 3, 6, 12 and 24 months. The primary outcome was International Knee Documentation Committee function from baseline (ACL rupture) to 6 months postoperatively. Secondary outcomes included (1) other patient outcome reporting metrics, Lysholm knee score, Knee Injury and Osteoarthritis Outcome Score and Visual Analog Scale; (2) the use of Kneelax3 knee stabiliser to assess knee stability; (3) occurrence of adverse events, such as graft refraction or symptomatic instability, postoperative infection and contralateral injury and (4) magnetic resonance images at 12 and 24 months after ACLR.
This trial was approved by the Medical Ethics Committee of the Xiangya Hospital of Central South University on 26 October 2021. Data will be published in peer-reviewed journals and presented at national and international conferences.
ChiCTR2200057526.
To examine the associations of cardiorespiratory fitness (VO2 max) and muscular strength with indicators related to the risk scale, such as perceived competence, sensation seeking, competitiveness, risk taking and risk perception in sports.
Cross-sectional study.
High schools from the Region of Murcia (Spain).
Three-hundred-and-seventeen adolescents participated (mean age: 13.69±1.2 years old).
Body mass, body height, Course-Navette test, upper limb strength and psychoeducational factors that determine the propensity towards sports accidents in school children, the Sports Accident Propensity Scale were evaluated. It was performance t-test for independent samples, stepwise multiple linear regression models and a multiple mediation analysis.
The analysis showed significant differences with respect to sex in height, VO2 max, handgrip strength and in all factors of the questionnaire (p=0.02-2 max, strength in the handgrip test and age showed a higher score in factors 1 and 3. Higher scores in factor 2 were associated with better VO2 max and strength in handgrip test. Youngers and better values of strength in the handgrip showed higher score in factors 4 and 5. The mediation analysis with two mediating variables (handgrip strength and VO2 max) showed a significant indirect effect. When handgrip strength and VO2 max were included in the equations, the association between sex and each factor ceased to be significant.
This study highlights the potential benefits of muscular strength (handgrip) and VO2 max in the perceived risk scale, and the variable of age on this.
Clinical trial: NCT05544370 (pre-results).
The aim included investigation of the associations between sedentary (SED), low-intensity physical activity (LIPA), moderate-to-vigorous intensity PA (MVPA) and the prevalence of subclinical atherosclerosis in both coronaries and carotids and the estimated difference in prevalence by theoretical reallocation of time in different PA behaviours.
Cross-sectional.
Multisite study at university hospitals.
A total of 22 670 participants without cardiovascular disease (51% women, 57.4 years, SD 4.3) from the population-based Swedish CArdioPulmonary bioImage study were included. SED, LIPA and MVPA were assessed by hip-worn accelerometer.
Any and significant subclinical coronary atherosclerosis (CA), Coronary Artery Calcium Score (CACS) and carotid atherosclerosis (CarA) were derived from imaging data from coronary CT angiography and carotid ultrasound.
High daily SED (>70% 10.5 hours/day) associated with a higher OR 1.44 (95% CI 1.09 to 1.91), for significant CA, and with lower OR 0.77 (95% CI 0.63 to 0.95), for significant CarA. High LIPA (>55% 8 hours/day) associated with lower OR for significant CA 0.70 (95% CI 0.51 to 0.96), and CACS, 0.71 (95% CI 0.51 to 0.97), but with higher OR for CarA 1.41 (95% CI 1.12 to 1.76). MVPA above reference level, >2% 20 min/day, associated with lower OR for significant CA (OR range 0.61–0.67), CACS (OR range 0.71–0.75) and CarA (OR range 0.72–0.79). Theoretical replacement of 30 min of SED into an equal amount of MVPA associated with lower OR for significant CA, especially in participants with high SED 0.84 (95% CI 0.76 to 0.96) or low MVPA 0.51 (0.36 to 0.73).
MVPA was associated with a lower risk for significant atherosclerosis in both coronaries and carotids, while the association varied in strength and direction for SED and LIPA, respectively. If causal, clinical implications include avoiding high levels of daily SED and low levels of MVPA to reduce the risk of developing significant subclinical atherosclerosis.
FreshRSS 