BACKGROUND: Sarcopenia and frailty often worsen in older adults because of declines in activities of daily living and social connections that are associated with chronic diseases and traumatic injuries such as falls and fractures. Exercise intervention for sarcopenia can take >3 months to improve muscle mass, muscle strength, and walking speed. Thus, a specialized intervention system for shorter periods of time is needed. In this study, we aimed to evaluate the short-term efficacy of an exercise program using the wearable cyborg Hybrid Assistive Limb (HAL) lumbar type in physical function in mobility-limited older adults who do not require transition to long-term care.
METHODS: This randomized, single-blind, parallel-group study involved 79 community-dwelling older adults with physical frailty or locomotive syndrome assigned to an intervention group (n = 40) with the HAL lumbar type exercise program or a control group (n = 39) without the exercise program. The intervention group underwent trunk training (including trunk and hip flexion, standing and sitting from a single sitting position, and squats) and gait training (treadmill and parallel bars) twice a week for 5 weeks while wearing the HAL lumbar type. The 10-m usual and maximum walking speeds, Timed Up and Go test results, 5-times chair-standing test results, 5-question Geriatric Locomotive Function Scale (GLFS-5) scores, body-fat percentage, and muscle mass were measured before and after the intervention and analyzed using the intention-to-treat method.
RESULTS: The intervention (23 % male; mean age, 74.7 ± 4.7 years) and control (21 % male; mean age, 75.1 ± 4.1 years) groups did not differ significantly in baseline characteristics. Seventy-seven participants completed the program; two withdrew for personal reasons. The mean difference (standard error) between the groups for the primary outcome (usual walking speed) was 0.35 (0.04) m/s; the time-by-group interaction was significant (p < 0.001). Secondary outcomes (maximum walking speed, Timed Up and Go test results, 5-times chair-standing test results, and GLFS-5 scores) significantly improved in the intervention group. Body composition was unchanged in both groups.
CONCLUSIONS: A 5-week exercise program using the HAL lumbar type is a promising option for community-dwelling older adults with limited mobility who do not require nursing care, resulting in clinically meaningful improvements in most physical functions within a short period.

Women who undergo cesarean delivery have reported experiencing mood distress related to the surgery and postoperative pain. Heart rate variability biofeedback (HRVB) training is known to have positive effects on mental health, but its effects on women undergoing cesarean delivery have not yet been determined. This study evaluated the effects of an HRVB training intervention on stress, anxiety, and depression in women undergoing cesarean delivery. We hypothesized that 10 sessions of HRVB training could cumulatively improve emotion regulation in participants. This study was designed as a double-blinded randomized controlled trial involving a total of 86 enrolled women who were then divided into two groups: intervention and control. During their hospitalization, the intervention group underwent HRVB training daily, while both groups received standard perinatal care. Heart rate variability (HRV) was assessed using root mean square of successive differences (RMSSD), standard deviation of normal-to-normal intervals (SDNN), high-frequency power (HF) and low-frequency power (LF). HRV parameters, stress, anxiety, and depression were evaluated at baseline and on the fifth day after childbirth. Intention-to-treat (ITT) analyses examined change over time between groups. Although no significant effects were found for the RMSSD and HF, a significant increase was observed in SDNN (F = 13.43, p = < 0.001, ƞ2 = 0.14), and LF at post-assessment (F = 4.26, p = .04, ƞ2 = 0.05) compared to the control group. Except for the depression variable, stress (F = 6.11, p = .02, ƞ2 = 0.07) and anxiety (F = 8.78, p = .004, ƞ2 = 0.10) significantly decreased compared to the control group on the fifth postpartum day. Furthermore, post-hoc analysis showed that HRVB was more effective in decreasing mild to severe depressive symptoms (F = 7.60, p = .001, ƞ2 = 0.27). The intervention program successfully decreased self-perceived stress and anxiety in the postpartum period and relieved symptoms in more severely depressed participants. Our findings suggest that this program is suitable and beneficial for application in women during the early postpartum period following cesarean delivery.

UNASSIGNED: Various biofeedback stimulation techniques for managing sleep bruxism (SB) have recently emerged; however, the effect of the successive application of vibratory feedback stimulation has not been clarified. This study aimed to elucidate the effect of vibration feedback stimulation via an oral appliance (OA) on SB.
UNASSIGNED: This prospective, single-arm, open-label intervention study included 20 participants diagnosed with \"definite\" SB who wore a specially designed OA for 98 nights at home. A force-based SB detection system triggered a vibrator attached to the OA. Vibratory stimulation was withheld during the first 3-week adaptation period (weeks 1-3), applied during the 9-week stimulation period (weeks 4-12), and withheld again during the post-stimulation period (weeks 13-14). The number and duration of SB events per hour of sleep were calculated based on piezoelectric signals recorded with the OA-based vibration feedback device and compared between weeks 3 and 4, 8, 12, and 14 and between weeks 12 and 14 using the Friedman test (post-hoc test with Bonferroni correction).
UNASSIGNED: The duration of SB events significantly decreased after vibratory stimulation (weeks 3 versus 4, 8, and 12: P < 0.001, P = 0.026, and P = 0.033, respectively) and then significantly increased upon cessation of vibratory stimulation after the stimulation period (weeks 12 versus 14: P < 0.001).
UNASSIGNED: Contingent vibratory stimulation through an OA-based vibration feedback device may suppress SB-related masticatory muscle activity continuously for 9 weeks and may be an effective alternative for managing SB.

BACKGROUND: Low anterior resection syndrome (LARS) is a distressing condition that affects approximately 25-80% of patients following surgery for rectal cancer. LARS is characterized by debilitating bowel dysfunction symptoms, including fecal incontinence, urgent bowel movements, and increased frequency of bowel movements. Although biofeedback therapy has demonstrated effectiveness in improving postoperative rectal control, the research results have not fulfilled expectations. Recent research has highlighted that stimulating the pudendal perineal nerves has a superior impact on enhancing pelvic floor muscle function than biofeedback alone. Hence, this study aims to evaluate the efficacy of a combined approach integrating biofeedback with percutaneous electrical pudendal nerve stimulation (B-PEPNS) in patients with LARS through a randomized controlled trial (RCT).
METHODS: In this two-armed multicenter RCT, 242 participants with LARS after rectal surgery will be randomly assigned to undergo B-PEPNS (intervention group) or biofeedback (control group). Over 4 weeks, each participant will undergo 20 treatment sessions. The primary outcome will be the LARS score. The secondary outcomes will be anorectal manometry and pelvic floor muscle electromyography findings and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scores. Data will be collected at baseline, post-intervention (1 month), and follow-up (6 months).
CONCLUSIONS: We anticipate that this study will contribute further evidence regarding the efficacy of B-PEPNS in alleviating LARS symptoms and enhancing the quality of life for patients following rectal cancer surgery.
BACKGROUND: Chinese Clincal Trials Register ChiCTR2300078101. Registered 28 November 2023.

UNASSIGNED: Heart rate variability biofeedback (HRVB) is a well-studied intervention known for its positive effects on emotional, cognitive, and physiological well-being, including relief from depressive symptoms. However, its practical use is hampered by high costs and a lack of trained professionals. Smartphone-based HRVB, which eliminates the need for external devices, offers a promising alternative, albeit with limited research. Additionally, premenstrual symptoms are highly prevalent among menstruating individuals, and there is a need for low-cost, accessible interventions with minimal side effects. With this pilot study, we aim to test, for the first time, the influence of smartphone-based HRVB on depressive and premenstrual symptoms, as well as anxiety/stress symptoms and attentional control.
UNASSIGNED: Twenty-seven participants with above-average premenstrual or depressive symptoms underwent a 4-week photoplethysmography smartphone-based HRVB intervention using a waitlist-control design. Laboratory sessions were conducted before and after the intervention, spaced exactly 4 weeks apart. Assessments included resting vagally mediated heart rate variability (vmHRV), attentional control via the revised attention network test (ANT-R), depressive symptoms assessed with the BDI-II questionnaire, and stress/anxiety symptoms measured using the DASS questionnaire. Premenstrual symptomatology was recorded through the PAF questionnaire if applicable. Data analysis employed linear mixed models.
UNASSIGNED: We observed improvements in premenstrual, depressive, and anxiety/stress symptoms, as well as the Executive Functioning Score of the ANT-R during the intervention period but not during the waitlist phase. However, we did not find significant changes in vmHRV or the Orienting Score of the ANT-R.
UNASSIGNED: These findings are promising, both in terms of the effectiveness of smartphone-based HRVB and its potential to alleviate premenstrual symptoms. Nevertheless, to provide a solid recommendation regarding the use of HRVB for improving premenstrual symptoms, further research with a larger sample size is needed to replicate these effects.

OBJECTIVE: Investigate effects of integrated training for pelvic floor muscles (PFM) with and without transabdominal ultrasonography (TAUS) imaging-guided biofeedback in postpartum women with pregnancy-related pelvic girdle pain (PPGP).
METHODS: Three-arm, single-blinded randomized controlled trial SETTING: University laboratory PARTICIPANTS: Fifty-three postpartum women with PPGP randomized into stabilization exercise with TAUS-guided biofeedback (BIO+EXE), exercise (EXE), and control (CON) groups.
METHODS: The BIO+EXE and EXE groups underwent an 8-week exercise program, with the BIO+EXE group receiving additional TAUS-guided biofeedback for PFM training during the first 4 weeks. The CON group only received a pelvic educational session.
METHODS: Primary outcomes included self-reported pain (numeric rating scale) and disability (pelvic girdle questionnaire). Secondary outcomes included functional tests (active straight leg raising [ASLR] fatigue, timed up-and-go, and 6-meter walking tests) and muscle contractibility indicated by muscle thickness changes for abdominal muscles and bladder base displacement for PFM (ultrasonographic measures).
RESULTS: The BIO+EXE group had lower pain [1.8 (1.5) vs. 4.4 (1.5), mean difference -2.6, 95% confidence interval (CI) -3.9 to -1.2] and disability [14% (10) vs. 28% (21), mean difference -14, 95% CI -25 to -2] and faster walking speed [3.1 seconds (1) vs. 3.3 seconds (1), mean difference -0.2, 95% CI -1.0 to -0.2] than the CON group. The EXE group only had lower pain intensity compared to the CON group [2.7 (2.0) vs. 4.4 (1.5), mean difference -1.7, 95% CI -3.1 to -0.4]. No significant differences were observed among groups in timed up-and-go, ASLR fatigue, or muscle contractibility.
CONCLUSIONS: Integrated training for PFM and stabilization with TAUS-guided biofeedback seems to be beneficial for reducing pain and disability in postpartum women with PPGP. CONTRIBUTION OF THE PAPER.

Objective: College students experience intense anxiety, for which biofeedback mindfulness techniques show effectiveness in relief. However, typical biofeedback products often lead to user fatigue and boredom because of a single or fixed feedback and lack of focus on mindfulness enhancement. Materials and Methods: In this research, we developed Mindjourney, a VR-based respiratory feedback mindfulness system, designed to enhance mindfulness and alleviate anxiety through continuous/noncontinuous feedback and nonjudgmental reward/punishment for self-perception and attention management. A randomized controlled trial involved 72 college students, split equally into short-term (n = 34, age: 23.11 ± 1.729) and 4-week long-term (n = 38, age: 24.12 ± 1.408) groups, with equal randomization for intervention and control groups. Pre/postintervention tests were measured by using Trait Anxiety Inventory (TAI) and Five Facet Mindfulness Questionnaire (FFMQ) for long-term groups and Galvanic Skin Response and State Anxiety Inventory (SAI) for short-term groups. Results: Results showed that the long-term intervention group showed a significant increase in mindfulness (P = 0.001 for FFMQ total score). Furthermore, observe and act with awareness subscales showed significant increase after intervention (P = 0.034 for observe, P < 0.001 for act with awareness) compared with the control group. Both intervention groups demonstrated a significant decrease in anxiety levels compared with the control groups (P = 0.049 for SAI, P = 0.01 for TAI). Moreover, participants expressed high interest in this biofeedback mindfulness system and willingness for long-term usage. Conclusion: The proposed biofeedback mindfulness practice system could potentially facilitate mindfulness practice and serve as a convenient tool for anxiety relief in campus college students.

BACKGROUND: 43 % of people who are diagnosed with COVID-19 will experience persistent symptoms, also known as \"long COVID,\" which lasts past the recovery of the acute infection. Long COVID symptoms overlap with symptoms that the Biosound Therapy System (BTS) has been shown to improve. The BTS is a multimodal treatment that includes biofeedback, vibroacoustic therapy synchronized with music that plays binaural beats, and video content. This study aimed to determine feasibility for a future full-scale Randomized Controlled Trial (RCT) and explore the impact of the BTS on long COVID symptoms.
METHODS: This pre-post pilot study was conducted in an outpatient mental health clinic. Adults aged 20-65 years old with persistent COVID-19 symptoms were screened and randomly assigned to the intervention or control group. The intervention group was given 8 Biosound Therapy sessions during a period of 4 weeks. All participants were assessed at baseline and at post-intervention using the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item scale (GAD-7), Cambridge Brain Sciences (CBS) tasks, and the COVID-19 Persistent Symptom Questionnaire. The feasibility outcomes were recruitment rates, retention rates, and open-ended questions about participants\' experiences.
RESULTS: 15 participants enrolled in the study and 13 completed the study (9 intervention, 4 control). Trial recruitment ended prematurely due to the emergence of the Omicron variant of COVID-19. Participants responded to open-ended questions with only positive remarks and made no comments on the study not being feasible. A Wilcoxon signed-rank test indicated that compared to baseline, participants in the intervention group had significant improvement in their GAD-7 score, PHQ9 score, 2 Cambridge Brain Science tasks (\"Odd\" and \"Double Trouble\"), fatigue, and difficulties in concentrating or remembering (p < 0.05; 95 % CI).
CONCLUSIONS: The intervention group showed promising improvement without reported side effects. A full-scale RCT is feasible as long as the recruitment setting is changed to a location that allows access to more patients with long COVID. Results were limited due to the small sample size; therefore, a full-scale trial is needed.

This study evaluated learning and recall effects following a feedback-based retraining program. A 6-month follow-up of a quasi-randomized controlled trial was performed with and without recall. Twenty runners were assigned to experimental or control groups and completed a 3-week running program. A body-worn system collected axial tibial acceleration and provided real-time feedback on peak tibial acceleration for six running sessions in an athletic training facility. The experimental group received music-based biofeedback in a faded feedback scheme. The controls received tempo-synchronized music as a placebo for blinding purposes. The peak tibial acceleration and vertical loading rate of the ground reaction force were determined in a lab at baseline and six months following the intervention to assess retention and recall. The impacts of the experimental group substantially decreased at follow-up following a simple verbal recall (i.e., run as at the end of the program): peak tibial acceleration:-32%, p = 0.018; vertical loading rate:-34%, p = 0.006. No statistically significant changes were found regarding the retention of the impact variables. The impact magnitudes did not change over time in the control group. The biofeedback-based intervention did not induce clear learning at follow-up, however, a substantial impact reduction was recallable through simple cueing in the absence of biofeedback.

BACKGROUND: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach.
OBJECTIVE: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being.
METHODS: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV.
RESULTS: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant.
CONCLUSIONS: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions.