Feasibility and safety of in-bed cycling/stepping in critically ill patients: A study protocol for a pilot randomized controlled clinical trial.

BACKGROUND: Intensive care unit (ICU)-acquired weakness (ICU-AW) is one of the most common complications of post-ICU syndrome. It is the leading cause of gait disturbance, decreased activities of daily living, and poor health-related quality of life. The early rehabilitation of critically ill patients can reduce the ICU-AW. We designed a protocol to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. METHODS: The study is designed as a single-center, single-blind, pilot, randomized, parallel-group study. After the screening, participants are randomly allocated to two groups, stratified by mechanical ventilation status. The intervention group will be provided with exercises of in-bed cycling/stepping according to the level of consciousness, motor power, and function in addition to conventional rehabilitation. In contrast, the control group will be provided with only conventional rehabilitation. The length of intervention is from ICU admission to discharge, and interventions will be conducted for 20 minutes, a maximum of three sessions per day. RESULTS: The outcomes are the number and percentage of completed in-bed cycling/stepping sessions, the duration and percentage of in-bed cycling/stepping sessions, and the number of cessations of in-bed cycling/stepping sessions, the interval from ICU admission to the first session of in-bed cycling/stepping, the number and percentage of completed conventional rehabilitation sessions, the duration and percentage of conventional rehabilitation sessions, the number of cessations of conventional rehabilitation sessions, the number of adverse events, level of consciousness, functional mobility, muscle strength, activities of daily living, and quality of life. DISCUSSION: This study is a pilot clinical trial to investigate the feasibility and safety of conventional rehabilitation with additional in-bed cycling/stepping in critically ill patients. If the expected results are achieved in this study, the methods of ICU rehabilitation will be enriched. TRIAL REGISTRATION: clinicialtrials.gov, Clinical Trials Registration #NCT05868070.

Exercise Management Using a Mobile App in Patients With Parkinsonism: Prospective, Open-Label, Single-Arm Pilot Study.

BACKGROUND: Patients with parkinsonism have higher inactivity levels than the general population, and this results in increased comorbidities. Although exercise has benefits for motor function and quality of life (QOL) in patients with parkinsonism, these patients face many barriers to exercise participation, such as lack of motivation, fatigue, depression, and time constraints. Recently, the use of mobile apps has been highlighted as a remote exercise management strategy for patients with chronic diseases. OBJECTIVE: This study aimed to evaluate the effects of home-based exercise management with a customized mobile app on the exercise amount, physical activity, and QOL of patients with parkinsonism. METHODS: This was a prospective, open-label, single-arm pilot study. The therapist installed the app in the smartphones of the participants and educated them on how to use the app. The therapist developed an individualized multimodal exercise program that consisted of stretching, strengthening, aerobic, balance and coordination, and oral-motor and vocal exercises. Participants were encouraged to engage in an 8-week home-based exercise program delivered through a customized app. The alarm notifications of the app provided reminders to exercise regularly at home. The primary outcome was the exercise amount. The secondary outcomes were assessed using the International Physical Activity Questionnaire (IPAQ), Parkinson's Disease Questionnaire-39 (PDQ-39), and Geriatric Depression Scale (GDS). The usability of the customized app was assessed using a self-report questionnaire. RESULTS: A total of 21 participants with parkinsonism completed the intervention and assessment between September and December 2020 (mean age: 72 years; women: 17/21, 81%; men: 4/21, 19%). The participants reported a significant increase in the total amount of exercise (baseline: mean 343.33, SD 206.70 min/week; 8-week follow-up: mean 693.10, SD 373.45 min/week; P<.001) and in the amount of each exercise component, including stretching, strengthening, balance and coordination, and oral-motor and vocal exercise after 8 weeks. Analysis of the secondary outcomes revealed significant improvements in the IPAQ (P=.006), PDQ-39 (P=.02), and GDS (P=.04) scores. The usability of the program with the mobile app was verified based on the positive responses such as "intention to use" and "role expectation for rehabilitation." CONCLUSIONS: Exercise management with a customized mobile app may be beneficial for improving exercise adherence, physical activity levels, depression management, and QOL in patients with parkinsonism. This remotely supervised technology-based, reinforcing, and multimodal exercise management strategy is recommended for use in patients with parkinsonism. In addition, this program proved useful as an alternative exercise management strategy during the COVID-19 pandemic when patients with Parkinson disease were less physically active than before and showed aggravation of symptoms. However, additional clinical trials are needed to evaluate the efficacy of this exercise program in a large population and to confirm its disease-modifying effects.

Knee Extensor Strength Measurement in Patients With Limited Physical Activity Using a Supine Dynamometer Anchoring Frame.

OBJECTIVE: To investigate the reliability of knee extensor strength measurements using a supine hand-held dynamometer (HHD) anchoring frame in patients with limited physical activity. Although an HHD is suitable for bedside use, its inter-rater reliability is low because measurements can be influenced by tester strength. METHODS: Maximal knee extensor isometric strength was measured using an HHD anchored to the supine frame. Three trials of three maximal contractions were assessed by two raters. RESULTS: A total of 33 inpatients who were non-ambulatory due to acute illness participated in the study. The intraclass correlation coefficients were 0.974 (inter-rater) and 0.959 (intra-rater). The minimal detectable changes in intra- and inter-observer measurements were 29.46 N (24.10%) and 36.73 N (29.26%), respectively. The limits of agreement ranged from -19.79% to 24.81% for intra-rater agreement and from -21.45% to 37.07% for inter-rater agreement. CONCLUSION: The portable dynamometer anchoring system can measure the isometric strength of the knee extensor reliably in the supine position, and could be used for measurements in patients who have difficulty visiting the laboratory and maintaining a seated posture.

Reliability and validity of knee extensor strength measurements using a portable dynamometer anchoring system in a supine position.

BACKGROUND: Muscle strength measurements using hand-held dynamometry (HHD) can be affected by the inadequate strength of the tester and lack of stabilization of the participants and the device. A portable HHD anchoring system was designed that enabled the measurement of isometric knee extensor muscle strength in a supine position. This can be used with individuals who are unable to assume the sitting position required for the measurement of knee extensor strength in conventional isokinetic dynamometry (IKD). The aim of this study was to evaluate the reliability and validity of knee extensor strength measurements using this device. METHODS: The maximal knee extensor isometric strength of the dominant leg in healthy adults aged 20 to 40 years was tested. Three trials of three contractions were assessed by two raters using the portable dynamometer anchoring system whilst the participant was in the supine position. After the three measurement trials, peak knee extensor torque was evaluated using IKD. The intraclass correlation coefficient (ICC) and 95% limits of agreement (LOA) for intra- and inter-rater reliability were obtained. RESULTS: Thirty-nine participants (19 male and 20 female, aged 30.08 ± 4.16 y), completed the three measurement trials. The ICC for intra-rater reliability was 0.98 for the maximum measurements of knee extensor strength (95% confidence interval [CI]: 0.96-0.98) and 0.98 (95% CI: 0.96-0.99) for inter-rater reliability. The mean difference (%) between the maximum knee extensor strength measurements of each trial was 1.02% (LOA range: - 11.13 to 13.16%) for intra-rater and - 1.44% (LOA range: - 13.98 to 11.08%) for inter-rater measurements. The Pearson correlation coefficient of the maximum voluntary peak torque measurements with the portable dynamometer anchoring system and IKD was 0.927. CONCLUSIONS: The portable dynamometer anchoring system is a reliable and valid tool for measuring isometric knee extensor strength in a supine position. Future clinical feasibility studies are needed to determine if this equipment can be applied to people with severe illness or disabilities. TRIAL REGISTRATION: KCT0003041 .