The Effects of a Lifestyle Intervention Supported by the InterWalk Smartphone App on Increasing Physical Activity Among Persons With Type 2 Diabetes: Parallel-Group, Randomized Trial.

BACKGROUND: Effective and sustainable implementation of physical activity (PA) in type 2 diabetes (T2D) health care has in general not been successful. Efficacious and contemporary approaches to support PA adherence and adoption are required. OBJECTIVE: The primary objective of this study was to investigate the effectiveness of including an app-based (InterWalk) approach in municipality-based rehabilitation to increase moderate-and-vigorous PA (MVPA) across 52 weeks compared with standard care among individuals with T2D. METHODS: The study was designed as a parallel-group, randomized trial with 52 weeks' intervention and subsequent follow-up for effectiveness (52 weeks from baseline). Participants were recruited between January 2015 and December 2016 and randomly allocated (2:1) into 12 weeks of (1) standard care + InterWalk app-based interval walking training (IWT; IWT group; n=140), or (2) standard care + the standard exercise program (StC group; n=74). Following 12 weeks, the IWT group was encouraged to maintain InterWalk app-based IWT (3 times per week for 30-60 minutes) and the StC group was encouraged to maintain exercise without structured support. Moreover, half of the IWT group (IWTsupport group, n=54) received additional motivational support following the 12-week program until 52-week follow-up. The primary outcome was change in objectively measured MVPA time (minutes/day) from baseline to 52-week follow-up. Key secondary outcomes included changes in self-rated physical and mental health-related quality of life (HRQoL), physical fitness, weight, and waist circumference. RESULTS: Participants had a mean age of 59.6 (SD 10.6) years and 128/214 (59.8%) were men. No changes in MVPA time were observed from baseline to 52-week follow-up in the StC and IWT groups (least squares means [95% CI] 0.6 [-4.6 to 5.8] and -0.2 [-3.8 to 3.3], respectively) and no differences were observed between the groups (mean difference [95% CI] -0.8 [-8.1 to 6.4] minutes/day; P=.82). Physical HRQoL increased by a mean of 4.3 (95% CI 1.8 to 6.9) 12-item Short-Form Health Survey (SF-12) points more in the IWT group compared with the StC group (Benjamini-Hochberg adjusted P=.007) and waist circumference apparently decreased a mean of -2.3 (95% CI -4.1 to -0.4) cm more in the IWT group compared with the StC group but with a Benjamini-Hochberg adjusted P=.06. No between-group differences were observed among the remaining key secondary outcomes. CONCLUSIONS: Among individuals with T2D referred to municipality-based lifestyle programs, randomization to InterWalk app-based IWT did not increase objectively measured MVPA time over 52 weeks compared with standard health care, although apparent benefits were observed for physical HRQoL. TRIAL REGISTRATION: ClinicalTrials.gov NCT02341690; https://clinicaltrials.gov/ct2/show/NCT02341690.

Effect of ecological momentary assessment, goal-setting and personalized phone-calls on adherence to interval walking training using the InterWalk application among patients with type 2 diabetes-A pilot randomized controlled trial.

OBJECTIVES: The objective was to investigate the feasibility and usability of electronic momentary assessment, goal-setting and personalized phone-calls on adherence to a 12-week self-conducted interval walking training (IWT) program, delivered by the InterWalk smartphone among patients with type 2 diabetes (T2D). METHODS: In a two-arm pilot randomized controlled trial (Denmark, March 2014 to February 2015), patients with T2D (18-80 years with a Body Mass Index of 18 and 40 kg/m2) were randomly allocated to 12 weeks of IWT with (experimental) or without additional support (control). The primary outcome was the difference between groups in accumulated time of interval walking training across 12 weeks. All patients were encouraged to use the InterWalk application to perform IWT for ≥90 minute/week. Patients in the experimental group made individual goals regarding lifestyle change. Once a week inquiries about exercise adherence was made using an ecological momentary assessment (EMA). In case of consistent self-reported non-adherence, the patients would receive a phone-call inquiring about the reason for non-adherence. The control group did not receive additional support. Information about training adherence was assessed objectively. Usability of the EMA was assessed based on response rates and self-reported satisfaction after 12-weeks. RESULTS: Thirty-seven patients with T2D (66 years, 65% female, hemoglobin 1Ac 50.3 mmol/mol) where included (n = 18 and n = 19 in experimental and control group, respectively). The retention rate was 83%. The experimental group accumulated [95%CI] 345 [-7, 698] minutes of IWT more than the control group. The response rate for the text-messages was 83% (68% for males and 90% for females). Forty-one percent of the experimental and 25% of the control group were very satisfied with their participation. CONCLUSION: The combination inquiry about adherence using EMA, goal-setting with the possibility of follow-up phone calls are considered feasible interventions to attain training adherence when using the InterWalk app during a 12-week period in patients with T2D. Some uncertainty about the effect size of adherence remains. TRIAL REGISTRATION: Clinicaltrials.gov NCT02089477.

Effectiveness of remote feedback on physical activity in persons with type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: The objective of this systematic review and meta-analysis was to examine the effectiveness of remote feedback intervention compared with standardized treatment on physical activity levels in persons with type 2 diabetes. Further, to investigate the influence of the length of intervention, number of contacts, study size, delivery of feedback, and preliminary face-to-face sessions. METHODS: A systematic literature search was conducted in May 2017, with a priori defined eligibility criteria: randomized controlled trials investigating remote feedback interventions in adult persons with type 2 diabetes, using physical activity as outcome. The effect size was calculated as standardized mean difference (SMD) and was pooled in a meta-analysis using a random-effects model. Meta-regression analyses were performed to examine if the observed effect size could be attributed to study- or intervention characteristics using these as covariates. RESULTS: The literature search identified 4455 articles of which 27 met the eligibility criteria. The meta-analysis including a total of 4215 participants found an overall effect size in favour of remote feedback interventions compared to standardized treatment, SMD = 0.33 (95% CI: 0.17 to 0.49), I2 = 81.7%). Analyses on study characteristics found that the effect on physical activity was only influenced by study size, with a larger effect in small studies. CONCLUSION: Adding remote feedback to standardized treatments aimed at increasing physical activity in persons with type 2 diabetes showed a small to moderate additional increase in physical activity levels. Systematic review registration: PROSPERO CRD42016033479.

Motivational factors for initiating, implementing, and maintaining physical activity behavior following a rehabilitation program for patients with type 2 diabetes: a longitudinal, qualitative, interview study.

AIM: To explore motivational factors for initiating, implementing, and maintaining physical activity following a rehabilitation program for patients with type 2 diabetes mellitus. METHODS: Semi-structured, individual, qualitative interviews with five informants from the InterWalk trial were conducted at three separate occasions; at initiation of the rehabilitation program, at completion of the 12-week program, and 52 weeks after enrolment. Interviews were audio-recorded, transcribed, and analyzed according to Systematic Text Condensation. The framework of Self-Determination Theory was applied to guide analysis after identification of preliminary themes. RESULTS: Commitment and obligation were emphasized as being motivational in initiating physical activity. Toward the termination of the program, this was challenged by an expressed need for autonomy. Successful behavioral change was characterized by transfer of commitment to a new structure in everyday life, which also honored the request for autonomy. Feeling capable of participating in physical activity was facilitated through knowledge, practical experience, and progress and considered motivational, whereas lack of progress extinguished motivation. Finally, enjoyment of the activity was determining for long-term maintenance of physical activity behavior. CONCLUSION: Satisfaction of innate psychological needs leads to more autonomous regulation of behavior and, through this study, we investigated determining factors for extrinsically motivated behavior and factors of importance to the internalization process.

Long-term effect of smartphone-delivered Interval Walking Training on physical activity in patients with type 2 diabetes: protocol for a parallel group single-blinded randomised controlled trial.

INTRODUCTION: Physical activity is a cornerstone in type 2 diabetes (T2D) rehabilitation. Effective long-term and low-cost strategies to keep these patients' physically active are needed. However, maintaining physical activity behaviour is difficult once formalised interventions end. Structured exercise training supported by mobile technology and remote feedback is potentially an effective strategy. The objective of the trial is to investigate whether mobile health support using the InterWalk application for smartphones is effective in increasing physical activity levels in persons with T2D over time compared with standard care. We investigate whether Interval Walking Training using the InterWalk application is superior to Danish municipality-based rehabilitation in increasing moderate-and-vigorous physical activity levels in patients with T2D across 52 weeks. Secondary, we hypothesise that a motivational programme added from end of intervention to 52 weeks further increases level of physical activity in everyday life in patients with T2D. METHODS AND ANALYSIS: The trial is a parallel-group, open-labelled, randomised controlled trial with long-term follow-up at 52 week including patients with T2D. The primary outcome is change in moderate-and-vigorous physical activity. The key secondary outcome includes motivation for physical activity behaviour change. Other secondary outcomes are VO2-peak, strength in the lower extremities. Exclusion criterion is medical contraindication to exercise. We include up to 246 patients and randomly allocate them into a control (standard group) or an experimental group (8-12 weeks of IWT supported by the smartphone-based InterWalk application) in a 1:2 fashion. After intervention, the experimental group is randomly allocated into two follow-up conditions with unsupervised IWT with or without motivational support until 52-week follow-up. The intention-to-treat principle is applied. ETHICS AND DISSEMINATION: The local regional Research Ethics Committee in Denmark (H-1-2014-074) and the Danish Data Protection Agency (j.nr. 2014-54-0897) have approved the trial. Positive, negative or inconclusive results will be disseminated in scientific journals and conferences. TRIAL REGISTRATION NUMBER: NCT02341690.

General practitioners' perceptions of COPD treatment: thematic analysis of qualitative interviews.

BACKGROUND: In Denmark, the treatment of COPD is mainly managed by general practitioners (GPs). Pulmonary rehabilitation (PR) is available to patients with COPD in the local community by GP referral, but in practice, many patients do not participate in rehabilitation. The aim of our study was to explore 1) GPs' perceptions of their role and responsibility in the rehabilitation of patients with COPD, and 2) GPs' perceptions of how patients manage their COPD. METHODS: The study was based on a qualitative design with semi-structured key-informant interviews with GPs. Investigator triangulation was applied during data generation, and analysis was done using thematic analysis methodology. RESULTS: Our main findings were that GPs relied on patients themselves to take the initiative to make clinic appointments and on professionals at health centers to provide the PR including consultations on lifestyle changes. The GPs experienced that patients chose to come to the clinic when they were in distress and that patients either declined or had poor adherence to rehabilitation when offered. The GPs were relieved that the health centers had taken over the responsibility of rehabilitation as GPs lacked the resources to discuss rehabilitation and follow up on individual plans. CONCLUSION: Our study suggested a potential self-reinforcing problem with the treatment of COPD being mainly focused on medication rather than on PR. Neither GPs nor patients used a proactive approach. Further, GPs were not fully committed to discuss non-pharmacological treatment and perceived the patients as unmotivated for PR. As such, there is a need for optimizing non-pharmacological treatment of COPD and in particular the referral process to PR.

The Effect of Game-Based Interventions in Rehabilitation of Diabetics: A Systematic Review and Meta-Analysis.

INTRODUCTION: Game-based interventions have been proposed as a way to improve both patient adherence to physical activity (PA) and disease-related knowledge to achieve better self-management of blood glucose levels (HbA1c). The objective of this study was to systematically review the literature on the effect of game-based interventions on HbA1c, diabetes-related knowledge, and physical outcomes in rehabilitation of diabetes patients. METHODS: We conducted a systematic literature search in MEDLINE, EMBASE, PEDro, Scopus, Cochrane Central Register of Controlled Trials, CINAHL, and Psych INFO in October 2014 based on a priori defined inclusion criteria: patients with diabetes (type 1 or type 2), game-based interventions, and randomized controlled trials. RESULTS: The database search identified 1,101 potential articles for screening, four of which were eligible for the present systematic review. Game-based interventions show no effect on HbA1c (three studies) standardized mean difference = -0.10, 95% confidence interval = [-0.33, 0.14] compared to usual care or waiting lists. Game-based interventions were superior to controls in improving health-related quality of life, muscle strength, and balance (one study). No difference was found between game-based interventions and usual care or waiting lists in terms of diabetes-related knowledge (one study). DISCUSSION: PA is important for diabetes management. The present review indicates that game-based interventions are not superior to ordinary PA in controlling HbA1c. Due to the weak methodological quality of the included studies and the very low body of evidence, the likelihood that the real effect of game-based interventions will be substantially different (i.e., large enough difference to possibly affect decision-making) is high.

Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study.

BACKGROUND AND OBJECTIVES: Total knee arthroplasty (TKA) is often associated with severe pain. Different regional anesthetic techniques exist, all with varying degrees of motor blockade. We hypothesized that pain relief provided by the adductor canal block (ACB) could increase functional muscle strength. METHODS: We included 50 TKA patients with severe movement-related pain; defined as having visual analog scale pain score of greater than 60 mm during active flexion of the knee. The ACB group received an ACB with ropivacaine 0.2% 30 mL and a femoral nerve block (FNB) with 30 mL saline. The FNB group received an ACB with 30 mL saline and an FNB with ropivacaine 0.2% 30 mL. We compared the effect of the ACB versus FNB on maximum voluntary isometric contraction of the quadriceps muscle relative to a postoperative baseline value. Secondary end points were differences between groups in ability to ambulate and changes in pain scores (Clinicaltrials.gov identifier NCT01922596). RESULTS: After block, the quadriceps maximum voluntary isometric contraction increased to 193% (95% confidence interval [CI], 143-288) of the baseline value in the ACB group and decreased to 16% (95% CI, 3-33) in the FNB group with an estimated difference of 178% (95% CI, 136-226), P < 0.0001. Pain scores were similar between groups. Before block, 2 of 25 patients in each group were unable to perform the Timed-Up-and-Go test; after block, this number increased to 7 of 25 in the FNB group and decreased to 0 of 25 in the ACB group. CONCLUSION: Adductor canal block provides a clinically relevant and statistically significant increase in quadriceps muscle strength for patients in severe pain after TKA.