Dataset Information

Pedometer Step Count Targets during Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial.

ABSTRACT: RATIONALE:Increasing physical activity is a key therapeutic aim in chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) improves exercise capacity, but there is conflicting evidence regarding its ability to improve physical activity levels. OBJECTIVES:To determine whether using pedometers as an adjunct to PR can enhance time spent in at least moderate-intensity physical activity (time expending ?3 metabolic equivalents [METs]) by people with COPD. METHODS:In this single-blind randomized controlled trial, participants were assigned 1:1 to receive a control intervention (PR comprising 8 wk, two supervised sessions per week) or the trial intervention (PR plus pedometer-directed step targets, reviewed weekly for 8 wk). In the randomization process, we used minimization to balance groups for age, sex, FEV1 percent predicted, and baseline exercise capacity and physical activity levels. Outcome assessors and PR therapists were blinded to group allocation. The primary analysis was based on the intention-to-treat principle. MEASUREMENTS AND MAIN RESULTS:The primary outcome was change from baseline to 8 weeks in accelerometer-measured daily time expending at least 3 METs. A total of 152 participants (72% male; mean [SD] FEV1 percent predicted, 50.5% [21.2]; median [first quartile, third quartile] time expending ?3 METs, 46 [21, 92] min) were enrolled and assigned to the intervention (n?=?76) or control (n?=?76) arm. There was no significant difference in change in time expending at least 3 METs between the intervention and control groups at 8 weeks (median [first quartile, third quartile] difference, 0.5 [-1.0, 31.0] min; P?=?0.87) or at the 6-month follow-up (7.0 [-9, 27] min; P?=?0.16). CONCLUSIONS:Pedometer-directed step-count targets during an outpatient PR program did not enhance moderate-intensity physical activity levels in people with COPD. Clinical trial registered with www.clinicaltrials.gov (NCT01719822).

SUBMITTER: Nolan CM

PROVIDER: S-EPMC5443901 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Pedometer Step Count Targets during Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial.

Nolan Claire M CM Maddocks Matthew M Canavan Jane L JL Jones Sarah E SE Delogu Veronica V Kaliaraju Djeya D Banya Winston W Kon Samantha S C SSC Polkey Michael I MI Man William D-C WD

American journal of respiratory and critical care medicine 20170501 10

<h4>Rationale</h4>Increasing physical activity is a key therapeutic aim in chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) improves exercise capacity, but there is conflicting evidence regarding its ability to improve physical activity levels.<h4>Objectives</h4>To determine whether using pedometers as an adjunct to PR can enhance time spent in at least moderate-intensity physical activity (time expending ≥3 metabolic equivalents [METs]) by people with COPD.<h4>Methods ...[more]

PMID: 27911566

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Project description:BACKGROUND:Regular physical activity (PA) is recommended for persons with chronic obstructive pulmonary disease (COPD). Interventions that promote PA and sustain long-term adherence to PA are needed. OBJECTIVE:We examined the effects of an Internet-mediated, pedometer-based walking intervention, called Taking Healthy Steps, at 12 months. METHODS:Veterans with COPD (N=239) were randomized in a 2:1 ratio to the intervention or wait-list control. During the first 4 months, participants in the intervention group were instructed to wear the pedometer every day, upload daily step counts at least once a week, and were provided access to a website with four key components: individualized goal setting, iterative feedback, educational and motivational content, and an online community forum. The subsequent 8-month maintenance phase was the same except that participants no longer received new educational content. Participants randomized to the wait-list control group were instructed to wear the pedometer, but they did not receive step-count goals or instructions to increase PA. The primary outcome was health-related quality of life (HRQL) assessed by the St George's Respiratory Questionnaire Total Score (SGRQ-TS); the secondary outcome was daily step count. Linear mixed-effect models assessed the effect of intervention over time. One participant was excluded from the analysis because he was an outlier. Within the intervention group, we assessed pedometer adherence and website engagement by examining percent of days with valid step-count data, number of log-ins to the website each month, use of the online community forum, and responses to a structured survey. RESULTS:Participants were 93.7% male (223/238) with a mean age of 67 (SD 9) years. At 12 months, there were no significant between-group differences in SGRQ-TS or daily step count. Between-group difference in daily step count was maximal and statistically significant at month 4 (P<.001), but approached zero in months 8-12. Within the intervention group, mean 76.7% (SD 29.5) of 366 days had valid step-count data, which decreased over the months of study (P<.001). Mean number of log-ins to the website each month also significantly decreased over the months of study (P<.001). The online community forum was used at least once during the study by 83.8% (129/154) of participants. Responses to questions assessing participants' goal commitment and intervention engagement were not significantly different at 12 months compared to 4 months. CONCLUSIONS:An Internet-mediated, pedometer-based PA intervention, although efficacious at 4 months, does not maintain improvements in HRQL and daily step counts at 12 months. Waning pedometer adherence and website engagement by the intervention group were observed. Future efforts should focus on improving features of PA interventions to promote long-term behavior change and sustain engagement in PA. CLINICALTRIAL:Clinicaltrials.gov NCT01102777; https://clinicaltrials.gov/ct2/show/NCT01102777 (Archived by WebCite at http://www.webcitation.org/6iyNP9KUC).

Project description:Background and objectivesAvailable evidence suggests that adults with chronic obstructive pulmonary disease (COPD) performed substantially worse than healthy controls on many balance measures and balance training can improve the balance measures in this population. We conducted this study to determine the effects of incorporating balance training into pulmonary rehabilitation (PR) on the incidence of falls at 12 months follow-up in high fall risk adults with COPD.MethodsWe conducted a prospective international multi-center randomized controlled trial. Eligible participants were adults with COPD at a high risk of future falls and were randomly assigned (1:1) to the intervention or control group. The intervention included personalized balance training for a targeted total of 90 min per week. Both the intervention and control groups received usual PR (2-3 times per week for 8-12 weeks). The primary outcome was the incidence of falls at 12-month follow-up using monthly fall diary calendars. Negative binomial regression or recurrent events models were used to examine the effects of the intervention on fall events. Multiple imputations were performed to deal with missing values.ResultsOf 258 participants who were enrolled in the trial, 178 provided falls information (intervention group = 91, control group = 87) and were included in the main analysis. Forty-one participants (45%) experienced at least one fall event in the intervention group and 33 (38%) in the control group (p = 0.34). The mean incidence of falls at 12 months was similar between the two groups (128 versus 128 per 100 person-years; mean difference: 0.30, 95% CI: -0.76 to 1.36 per 100 person-years). The results are robust after multiple imputations for missing data (n = 67).ConclusionsPR incorporating balance training compared to PR alone did not reduce the incidence of falls over the 12-month period in high fall risk adults with COPD.Trial registrationThe study was registered with ClinicalTrials.gov (NCT02995681) on 14/12/2016.

Project description:BACKGROUND:Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. A growing body of evidence shows that individuals with COPD have important deficits in balance control that may be associated with an increased risk of falls. Pulmonary rehabilitation (PR) is a key therapeutic intervention for individuals with COPD; however, current international guidelines do not include balance training and fall prevention strategies. OBJECTIVE:The primary aim of this trial is to determine the effects of PR with balance training compared to PR with no balance training on the 12-month rate of falls in individuals with COPD. Secondary aims are to determine the effects of the intervention on balance, balance confidence, and functional lower body strength, and to estimate the cost-effectiveness of the program. METHODS:A total of 400 individuals from nine PR centers across Canada, Europe, and Australia will be recruited to participate in a randomized controlled trial. Individuals with COPD who have a self-reported decline in balance, a fall in the last 2 years, or recent near fall will be randomly assigned to an intervention or control group. The intervention group will undergo tailored balance training in addition to PR and will receive a personalized home-based balance program. The control group will receive usual PR and a home program that does not include balance training. All participants will receive monthly phone calls to provide support and collect health care utilization and loss of productivity data. Both groups will receive home visits at 3, 6, and 9 months to ensure proper technique and progression of home exercise programs. The primary outcome will be incidence of falls at 12-month follow-up. Falls will be measured using a standardized definition and recorded using monthly self-report fall diary calendars. Participants will be asked to record falls and time spent performing their home exercise program on the fall diary calendars. Completed calendars will be returned to the research centers in prepaid envelopes each month. Secondary measures collected by a blinded assessor at baseline (pre-PR), post-PR, and 12-month follow-up will include clinical measures of balance, balance confidence, functional lower body strength, and health status. The cost-effectiveness of the intervention group compared with the control group will be evaluated using the incremental cost per number of falls averted and the incremental cost per quality-adjusted life years gained. RESULTS:Recruitment for the study began in January 2017 and is anticipated to be complete by December 2019. Results are expected to be available in 2020. CONCLUSIONS:Findings from this study will improve our understanding of the effectiveness and resource uses of tailored balance training for reducing falls in individuals with COPD. If effective, the intervention represents an opportunity to inform international guidelines and health policy for PR in individuals with COPD who are at risk of falling. TRIAL REGISTRATION:ClinicalTrials.gov NCT02995681; https://clinicaltrials.gov/ct2/show/NCT02995681 (Archived by WebCite at http://www.webcitation.org/6ukhxgAsg).

Project description:PurposeThis Stay Active after Rehabilitation (STAR) study examined the effects of a pedometer-based behavioral intervention for individuals with COPD during three weeks of inpatient pulmonary rehabilitation (PR) on patients' physical activity levels six weeks and six months after PR, including steps (primary outcome), moderate-intensity physical activity, and sedentary time as well as patient quality of life, symptoms, and other psychological and clinical variables.Patients and methodsRehabilitation patients with COPD wore a triaxial accelerometer (ActiGraph wGT3X) for seven days two weeks before (T0) as well as six weeks (T3) and six months (T4) after PR. In addition to the three-week inpatient PR (control group, CG), the randomly allocated intervention group (IG) received a brief pedometer-based behavioral intervention with the application of the following behavior-change techniques: performing the behavior, individual goal-setting, self-monitoring, and feedback. The effects were analyzed using analysis of covariance with an intention-to-treat approach.ResultsA total of 327 patients (69% male, age: 58 years, FEV1 (%): 53.5, six-minute walk distance: 447.8 m) were randomly allocated to either the IG (n = 167) or CG (n = 160). Although both groups increased their daily steps after PR (IG: MT3-T0 = 1152, CG: MT3-T0 = 745; IG: MT4-T0 = 795, CG: MT4-T0 = 300), the slightly higher increases in daily steps in the IG compared to the CG at T3 (Δ388 steps, d = 0.16) and T4 (Δ458 steps, d = 0.15) were not statistically significant (p > 0.05 for all). Patients in both groups showed moderate to high pre-post-changes in terms of secondary outcomes, but no advantage favoring the IG was found.ConclusionThe results show that adding a pedometer-based behavioral intervention to standard German three-week inpatient PR for COPD patients did not result in more physical activity in terms of steps and moderate-intensity physical activity or less sedentary time. However, both groups (IG and CG) showed remarkably enhanced physical activity levels six weeks and six months after PR, as well as improvements in other secondary outcomes (eg, quality of life).

Project description:ObjectiveThe present systematic review and meta-analysis of randomized clinical trials (RCTs) aimed to investigate the effects of pulmonary rehabilitation in individuals with chronic obstructive pulmonary disease (COPD).MethodsThe RCTs of pulmonary rehabilitation programs published between 1999 and 2021 were retrieved from electronic databases (PubMed, Cochrane Library, and Embase). Two reviewers independently assessed the topical relevance and trial quality and extracted data for meta-analysis using the Stata software version 14.0.ResultsA total of 39 trials involving 2,397 participants with COPD were evaluated. We found that patients who received pulmonary rehabilitation program had significant improvement in the 6-min walk test (6MWT), St. George Respiratory Questionnaire score, and the modified British Medical Research Council score as compared to those who received usual care. Yoga and Tai Chi showed significant improvement in the forced expiratory volume (FEV1)% in 1 s predicted value. However, no significant difference was detected in the modified Borg score, forced vital capacity (FVC), and FEV1/FVC predicted value between the pulmonary rehabilitation and usual care groups.ConclusionYoga and Tai Chi showed a significant improvement in the FEV1% predicted value. Also, pulmonary rehabilitation program improved the exercise capacity, the quality of life, and dyspnoea in patients with COPD.Key messagesA total of 39 trials involving 2,397 participants with COPD were evaluated.We found that patients who received pulmonary rehabilitation program had significant improvement in the 6MWT, St. George Respiratory Questionnaire score, and the modified British Medical Research Council score as compared to those who received usual care.Yoga and Tai Chi showed significant improvement in the FEV1% predicted value.No significant difference was detected in the modified Borg score, FVC, and FEV1/FVC predicted value between the pulmonary rehabilitation and usual care groups.

Dataset Information

Pedometer Step Count Targets during Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial.

Publications

Pedometer Step Count Targets during Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial.

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