DOI: 10.5061/dryad.v41ns1s6c
title: Effects of individualized step targets on physical activity in COPD. A randomized study

description: Purpose: Improving physical activity (PA) is important in patients with
 chronic obstructive pulmonary disease (COPD). Goal setting can be a
 possible intervention, but its effect cannot be maintained for six months.
 We evaluated the effects of providing an individualized target step count,
 reflecting the disease condition of each patient, on PA and other factors,
 such as myokines, after six months in patients with COPD. Patients and
 methods: We performed a randomized parallel group, open-label study
 (INTAR-Step study) between the target provision (intervention) group and
 the usual care (control) group and investigated differences in the
 proportion of subjects who achieved the target as a primary endpoint and
 differences in changes in PA parameters and myokines as secondary
 endpoints. This study was registered with UMIN-CTR (UMIN000046390, January
 13, 2022). Results: A total of 73 patients were analyzed (intervention,
 n=38; control, n=35). The proportion of participants in the intervention
 group who achieved their target step count did not show a significant
 increase relative to the control group (p=0.157). However, the change in
 step count, and change in duration of activity at ≥3.0 metabolic
 equivalents were significantly increased in the intervention group. The
 Changes in the Growth differentiation factor-15 (GDF-15), fatty
 acid-binding protein-3, and Irisin levels also increased in the
 intervention group. Furthermore, GDF-15 levels were significantly higher
 in patients with increased step counts than in those with decreased step
 counts. Conclusion: Providing individualized step targets did not increase
 the proportion of subjects who achieved their targets, but it increased
 their step counts after six months. GDF-15 may be involved in the increase
 in the step count.
description: Recruitment was performed at five institutes, namely Osaka
 Metropolitan University, Saga University, Yamaguchi University, Wakayama
 Medical University, and NHO Wakayama Hospital, from June 2022 to January
 2023. Written informed consent was obtained from all participants. This
 study was approved by the ethics committee of NHO Wakayama Hospital
 (approval number: 03-06; approval date: October 26, 2021) and registered
 with UMIN-CTR (UMIN000046390, January 13, 2022).
description: # Effects of individualized step targets on physical activity in COPD. A
 randomized study
 [https://doi.org/10.5061/dryad.v41ns1s6c](https://doi.org/10.5061/dryad.v41ns1s6c) ## Description of the data and file structure After obtaining informed consent (visit 1), participants were required to measure patient demographics, post-bronchodilator spirometry, patient-reported outcome measures (PROs), serum myokines, body composition, chest computed tomography (CT), transdermal advanced glycation end-products (AGEs), and PA using an accelerometer with a recording of a diary for 2 weeks (Data6_visit2.csv). Between four and twenty weeks after visit 1, participants were randomly assigned to the intervention or the control group (visit 2; week 0). Subjects in the intervention group were educated and encouraged to increase their step counts and were provided with the target step count value and a pedometer, whereas subjects in the control group were educated and encouraged to increase their step counts. Twelve weeks after visit 2 (visit3; week 12, permitted at week 8-19) patients were required to visit doctor and were encouraged to increase their step counts. Twenty-four weeks after visit 2 (visit 4; week 24, permitted at week 20–40) (Data5_visit4.csv), participants were required to measure their demographics, PROs, body composition, serum myokines, transdermal AGEs, and their PA using an accelerometer while recording a diary for 2 weeks. ### Files and variables #### File: Data6\_visit2.csv **Description:** Baseline data (at visit 1 and visit 2). This file contains baseline data (visit 1) and randomization results (visit 2). ##### Variables * Interv: intervention group; Cont, control group - Target value: individual target value of step count - Age: 5, 50-59; 6, 60-69; 7, 70-79; 8, 80-89 years old at the time of consent. - Smoking(pack-years): smoking history, expressed as packs x years. - Living alone(Y/N): Y, subject who lives alone; N, subject who lives with other persons - Occupation(Y/N): Y, subject who has a job; N, subject who has no job or is retired - Sex: binary variable left ambiguous to further de-identify patients - SpO2(%): lowest SpO2 values during six-minute walking test - BP(mmHg): blood pressure. expressed in mmHg - Hight(cm): expressed in cm - Weight(kg): expressed in kg - BMI(kg/m^2): body mass index, expressed in kg/m^2 - IC(L): inspiratory capacity, expressed in liter - FEV1(L): forced expiratory volume in one second, expressed in liter - FVC(L): forced vital capacity, expressed in liter - FVC%pred(%): forced vital capacity percent of predicted value, expressed in % - FEV1%pred(%): forced expiratory volume in one second percent of predicted value, expressed in % - FEV1/FVC(%): forced expiratory volume in one second / forced vital capacity, expressed in % - mMRC(point): score of modified Medical Research Council dyspnea scale - CAT(point): score of COPD assessment test - PROMS-D(point): score of patient-reported outcome measures for dyspnea - KCL(point): score of Kihon Checklist - MOCA-J(point): score of Japanese version of the Montreal Cognitive Assessment - AGE: AGE value measured with AGE scanner, AGE200® (Diagnoptics Technologies BV, Netherlands) - Phase A(˚): phase angle measured with bioelectric impedance analysis using a body composition analyzer, InBody S10® (InBody Japan Inc., Tokyo, Japan) - SMI(kg/m^2): smooth muscle index, expressed in kg/m^2 - Total PA(METs·h): the total physical activity, calculated as the sum of metabolic equivalents (METs) values (≥3.0 METs) x the time spent (hours) - Step(steps): number of step counts per day - 1-1.5METs(min): the duration of physical activity at 1.0-1.5 METs - ≥2METs(min): the duration of physical activity at ≥2.0 METs - ≥3METs(min): the duration of physical activity at ≥3.0 METs - GDF-15(pg/mL): growth differentiation factor-15, expressed in pg/mL - BDNF(pg/mL): brain-derived neurotrophic factor, expressed in pg/mL - Osteonectin(ng/mL): expressed in ng/mL - FABP-3(pg/mL): fatty acid-binding protein-3, expressed in pg/mL - FSTL-1(pg/mL): follistatin-like protein 1, expressed in pg/mL - Oncostatin M(pg/mL): expressed in pg/mL - FGF21(pg/mL): fibroblast growth factor-21, expressed in pg/mL - Irisin(ng/mL): expressed in ng/mL - Null: data could not be obtained - ND: not detected. - Reasons for “null” data: Since MoCA-J was set as an optional item, some data became “null”. E00073 could not obtain AGE data due to measurement error. E00028 and E00008 could not perform InBody due to right leg prosthesis and ICD implantation, respectively. E00077 could not fully obtain InBody data (phase angle and SMI) due to measurement error. E00068, and E00067 could not obtain phase angle data because the InBody at the facility did not support phase angle measurement.  E00031 was randomly assigned to the control group but it was found that he had refrained from going out due to fears of getting COVID-19. Therefore, his PA data were excluded from the analysis. #### File: Data5\_visit4.csv **Description:** 6-month evaluation (at visit 4). This file contains the data from 6 months after randomization (visit 4). ##### Variables * 0016, E00056, E00071, E00003, E00074, E00022, and E00031 were excluded at 6-month evaluation (visit 4) because they met exclusion criteria or invalid physical activity data. * Abbreviations of variables are same as “Baseline data (at visit 1 and visit 2)”. * Reasons for “null” data: Since MoCA-J was set as an optional item, some data became “null”. E00028 and E00008 could not perform InBody due to right leg prosthesis and ICD implantation, respectively. E00068, and E00067 could not obtain phase angle data because the InBody at the facility did not support phase angle measurement. #### **Change log** **May 2025:** * File Data3_visit3.csv was deleted because it was not necessary for this study. * File Data6_visit2.csv was renamed from Data5_visit2.csv * Variable 'Housemate' changed to 'Living alone'