Smartphone measurements of physical activity and fitness are associated with early trial discontinuation of patients in (hemato)oncology phase I/II clinical trials

Abstract Background Patients, who discontinue early, do not benefit from phase I/II clinical trials (early-phase clinical trials (EPCT)). In this study, associations between objective smartphone measurements of physical activity and fitness and early trial discontinuation in patients with cancer participating in EPCT were investigated. Methods Before start of treatment, physical activity (steps/day) and physical fitness (meters walked in 6 min) were measured with a smartphone, and patient-reported physical function (PRO-PF) was assessed (EORTC QLQ-C30-PF). Early trial discontinuation was defined as discontinuation ≤ 28 days. Univariable logistic regression analyses were performed to study associations of physical activity, fitness, and function with early trial discontinuation. Optimal cutoff values of physical activity and fitness were assessed with ROCs, based on positive predictive values (PPV). Results Median (interquartile range (IQR)) step count was 4263 (2548–6897) steps/day, mean ± standard deviation 6-min walking distance was 477 ± 120 m and median (IQR) PRO-PF score was 83 (67–95) points. Fourteen patients (12%) discontinued the trial early. Smartphone measurements of physical activity in units of 100 steps per day (odds ratio (OR) = 0.96, 95% CI = 0.94–0.99, p = 0.01), physical fitness (OR = 0.99, 95% CI = 0.98–0.99, p < 0.01), and PRO-PF (OR = 0.97, 95% CI = 0.94–1.00, p = 0.03) were associated with early trial discontinuation. Optimal cutoff values were < 900 steps for physical activity and < 285 m for physical fitness. PPV for early trial discontinuation was 100% in patients who walked both < 1500 steps per day and < 300 m in 6 min. Conclusions Objective smartphone measurements of physical activity and fitness are associated with early trial discontinuation. However, cutoff values should be externally validated in a larger cohort before implementation in clinical practice.

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Predictors for early trial discontinuation of patients with cancer participating in phase I clinical trials

Annals of Oncology ◽

10.1093/annonc/mdz244.058 ◽

2019 ◽

Vol 30 ◽

pp. v187 ◽

Cited By ~ 1

Author(s):

J.A.J. Douma ◽

L.M. Buffart ◽

M. Labots ◽

C.W. Menke-van derHouven van Oordt ◽

M. Skardhamar ◽

...

Keyword(s):

Clinical Trials ◽

Phase I ◽

Phase I Clinical Trials ◽

Patients With Cancer ◽

Early Trial ◽

Trial Discontinuation

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Exercise, genetics and prevention of type 2 diabetes

Essays in Biochemistry ◽

10.1042/bse0420177 ◽

2006 ◽

Vol 42 ◽

pp. 177-192 ◽

Cited By ~ 8

Author(s):

Gang Hu ◽

Jesús Rico-Sanz ◽

Timo A. Lakka ◽

Jaakko Tuomilehto

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Clinical Trials ◽

Physical Fitness ◽

Prospective Studies ◽

Dietary Modification ◽

Glucose Levels ◽

The Past ◽

Joint Associations

Type 2 diabetes is one of the fastest growing public health problems in both developed and developing countries. Cardiovascular disease is the most prevalent complication of type 2 diabetes. In the past decade, the associations of physical activity, physical fitness and changes in the lifestyle with the risk of type 2 diabetes have been assessed by a number of prospective studies and clinical trials. A few studies have also evaluated the joint associations of physical activity, body mass index and glucose levels with the risk of type~2 diabetes. The results based on prospective studies and clinical trials have shown that moderate or high levels of physical activity or physical fitness and changes in the lifestyle (dietary modification and increase in physical activity) can prevent type 2 diabetes.

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Clinical Predictors of Early Trial Discontinuation for Patients Participating in Phase I Clinical Trials in Oncology

Cancers ◽

10.3390/cancers13102304 ◽

2021 ◽

Vol 13 (10) ◽

pp. 2304

Author(s):

Joeri A. J. Douma ◽

Laurien M. Buffart ◽

Ramy Sedhom ◽

Mariette Labots ◽

Willemien C. Menke-van der Houven van Oordt ◽

...

Keyword(s):

Alkaline Phosphatase ◽

Phase I ◽

Alkaline Phosphatase Level ◽

Phase I Trials ◽

Opioid Use ◽

Performance Score ◽

Eligibility Criteria ◽

Elevated Alkaline Phosphatase ◽

Early Trial ◽

Trial Discontinuation

Despite stringent eligibility criteria for trial participation, early discontinuation often occurs in phase I trials. To better identify patients unlikely to benefit from phase I trials, we investigated predictors for early trial discontinuation. Data from 415 patients with solid tumors who participated in 66 trials were pooled for the current analysis. Early trial discontinuation was defined as (i) trial discontinuation within 28 days after start of treatment or (ii) discontinuation before administration of the first dosage in eligible patients. Multilevel logistic regression analyses were conducted to identify predictors for early trial discontinuation. Eighty-two participants (20%) demonstrated early trial discontinuation. Baseline sodium level below the lower limit of normal (OR = 2.95, 95%CI = 1.27–6.84), elevated alkaline phosphatase level >2.5 times the upper limit of normal (OR = 2.72, 95%CI = 1.49–4.99), performance score ≥ 1 (OR = 2.07, 95%CI = 1.03–4.19) and opioid use (OR = 1.82, 95%CI = 1.07–3.08) were independent predictors for early trial discontinuation. Almost 50% of the patients with hyponatremia and all four patients in whom all four predictors were present together discontinued the trial early. Hyponatremia, elevated alkaline phosphatase level, performance score ≥1 and opioid use were identified as significant predictors for early trial discontinuation. Hyponatremia was the strongest predictor and deserves consideration for inclusion in eligibility criteria for future trials.

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Evidence-Based Optimal Cutoff Values with the Validation of Criterion-Referenced Standards for Sarcopenic Elderly Fitness Improvement

BioMed Research International ◽

10.1155/2020/1638082 ◽

2020 ◽

Vol 2020 ◽

pp. 1-8

Author(s):

Hyunseok Jee ◽

Soo Hyun Park ◽

Saejong Park

Keyword(s):

Physical Fitness ◽

Roc Curve ◽

Scientific Evidence ◽

Exercise Program ◽

The Elderly ◽

Transitional Period ◽

Evidence Based ◽

Optimal Cutoff ◽

Cutoff Values ◽

Criterion Referenced

This study provides a newly updated perspective of information on severely screened 21 previous studies of the various measurement methods for improving physical fitness and providing determined cutoff values from our reserved elderly human database. We aimed to provide scientific evidence-based information regarding physical fitness standards for developing useful prognostics, promoting and maintaining health programs for sarcopenic elderly. 21 previous studies emphasizing criterion referenced standards and receiver operator characteristic (ROC) curve analyses for improving physical fitness were screened. For predicting the prevalence of sarcopenia, the t-test, logistic regression, linear regression, ROC curve analyses, and voluntary categorizations such as the twentieth or sixtieth percentile classification were used. Based on these scientific evidences, we determined cutoff values from our reserved DB and realized that 75 years for men and 70 years for women are the transitional period during which there are large declines in muscle and fat mass (p<0.01), which reflects physical function tests (p<0.01) in both genders. Using the six factors with ideal cutoff thresholds, an individual exercise program can be designed for alleviating symptoms of frailty caused by sarcopenia for the elderly.

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Epidemiological studies of exercise in diabetes prevention

Applied Physiology Nutrition and Metabolism ◽

10.1139/h07-030 ◽

2007 ◽

Vol 32 (3) ◽

pp. 583-595 ◽

Cited By ~ 44

Author(s):

Gang Hu ◽

Timo A. Lakka ◽

Tuomas O. Kilpeläinen ◽

Jaakko Tuomilehto

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Clinical Trials ◽

Physical Fitness ◽

Prospective Studies ◽

Scientific Evidence ◽

Total Mortality ◽

Epidemiological Studies ◽

Glucose Levels

Type 2 diabetes is one of the fastest growing public health problems in both developed and developing countries. It is estimated that the number of people with diabetes in the world will double in coming years, from 171 million in 2000 to 366 million in 2030. Cardiovascular disease accounts for more than 70% of total mortality among patients with type 2 diabetes. The associations of physical activity, physical fitness, and changes in the lifestyle with the risk of type 2 diabetes have been assessed by a number of prospective studies and clinical trials in the past decade. Several studies have also evaluated the joint associations of physical activity, body mass index, and glucose levels with the risk of type 2 diabetes. Prospective studies and clinical trials have shown that moderate or high levels of physical activity or physical fitness and changes in the lifestyle (dietary modification and increase in physical activity) can prevent type 2 diabetes. Our review of the scientific evidence confirms that 30 min/d of moderate- or high-level physical activity is an effective and safe way to prevent type 2 diabetes in all populations.

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Study on Health and Physical Fitness for Office Workers in Hong Kong: Phase I

Asian Journal of Physical Education & Recreation ◽

10.24112/ajper.21177 ◽

1996 ◽

Vol 2 (2) ◽

pp. 39-48

Author(s):

Pak Kwong CHUNG

Keyword(s):

Physical Activity ◽

Blood Pressure ◽

Heart Rate ◽

Health Status ◽

Physical Fitness ◽

Phase I ◽

Office Workers ◽

Resting Heart Rate ◽

Lung Capacity ◽

Cardiorespiratory Endurance

LANGUAGE NOTE | Document text in Chinese; abstract in English only.The study consisted of two phases: Phase I was designed to investigate the health status and physical fitness levels of office workers and phase II was conducted to examine the training effects of a circuit training on health and physical fitness of the workers. In phase I, health and stress inventories (Pace of Life Index, General Well-Being Scale, and Bacek Sports Questionnaire), health indices (blood total cholesterol, blood pressure, lung capacity, and resting heart rate), and physical fitness assessment (bicycle ergometer test; skinfold measurement, sit-ups test; grip strength test; and sit and reach test) were conducted to 171 (112 males & 59 females, aged 30-49) office workers from 22 local corporations. From Descriptive Statistics analyses, it was found that the overall health status and stress level of the office workers were at acceptable levels. However, the lung capacity of the workers was in the category of "fair". The total cholesterol level of the male 40-year old group was found higher than the optimal level. Most of the fitness indices of the workers were in categories of "average" or "fair" when comparing with that of the general population of U.S.A. The Correlation analyses shown that the female workers, with higher regular physical activity hours, had fewer incidents of low-back pain and lower resting heart rates. It was also found that the lower the percent body fat, the lower the systolic blood pressure and the better the cardiorespiratory endurance. Similar correlations were found in the male workers: the better the cardiorespiratory endurance, the lower the resting heart rate and systolic blood pressure for the workers. Researchers indicated that workers with higher levels of physical fitness would have higher working ability and productivity, it was suggested that local office workers should give priority to regular physical activity. Activities such as aerobic exercises, calisthenics, stretching, and muscular training should be included in the exercise programmes so that a total fitness can be developed.

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