scholarly journals A randomized controlled trial of the effect of supervised progressive cross-continuum strength training and protein supplementation in older medical patients: the STAND-Cph trial

2019 ◽  
Author(s):  
Mette Merete Pedersen ◽  
Janne Petersen ◽  
Nina Beyer ◽  
Helle Gybel Juul-Larsen ◽  
Pia Søe Jensen ◽  
...  

Abstract Background: During hospitalization, older adults (+65) are inactive, which puts them at risk of functional decline and loss of independence. Systematic strength training can prevent loss of functional performance and combining strength training with protein supplementation may enhance the response on muscle mass and strength . However, we lack knowledge about the effect of strength training commenced during hospitalization and continued after discharge in older medical patients. This assessor-blinded, randomized study investigated the effect of a simple, supervised strength training program for the lower extremities, combined with post-training protein supplementation during hospitalization and in the home setting for 4 weeks after discharge on change in mobility in older medical patients. Methods: Older medical patients (≥65 yrs) admitted acutely from their home to the Emergency Department were randomized to either standard care or supervised progressive strength training and an oral protein supplement during hospitalization and at home 3 days/week for 4 weeks after discharge. The primary outcome was between-group difference in change in mobility from baseline to 4 weeks after discharge assessed by the De Morton Mobility Index, which assesses bed mobility, chair mobility, static and dynamic balance, and walking. Secondary outcomes were 24-hour mobility, lower extremity strength, gait speed, grip strength and Activities of Daily Living. Results: Eighty-five patients were randomized to an intervention group (N=43) or a control group (N=42). In the intervention group, 43% were highly compliant with the intervention. Our intention to treat analysis revealed no between-group difference in mobility (mean difference in change from baseline to 4 weeks: -4.17 (95 % CI: -11.09;2.74; p=0.24) nor in any of the secondary outcomes. The per protocol analysis showed that the intervention group increased significantly more in the daily number of steps taken compared to the control group (mean difference in change from baseline to 4 weeks: 1033.4 steps (95 % CI: 4.1;2062.7), p=0.049, adjusted for mobility at baseline and length of stay; 1032.8 steps (95% CI: 3.6;2061.9), p=0.049, adjusted for mobility at baseline, length of stay and steps at baseline). Conclusions: Simple supervised strength training for the lower extremities, combined with protein supplementation initiated during hospitalization and continued at home for 4 weeks after discharge was not superior to usual care on change in mobility at 4 weeks in older medical patients. For the secondary outcome, daily number of steps, high compliance with the intervention resulted in a higher daily number of steps. Less than half of the patients were compliant with the intervention indicating that a simpler intervention might be needed. Trial registration: NCT01964482, https://clinicaltrials.gov/ct2/show/NCT01964482 , registration date: October 14, 2013, trial protocol: PubMed ID (PMID): 27039381.

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Mette Merete Pedersen ◽  
◽  
Janne Petersen ◽  
Nina Beyer ◽  
Helle Gybel-Juul Larsen ◽  
...  

Abstract Background During hospitalization, older adults (+ 65 years) are inactive, which puts them at risk of functional decline and loss of independence. Systematic strength training can prevent loss of functional performance and combining strength training with protein supplementation may enhance the response in muscle mass and strength. However, we lack knowledge about the effect of strength training commenced during hospitalization and continued after discharge in older medical patients. This assessor-blinded, randomized study investigated the effect of a simple, supervised strength training program for the lower extremities, combined with post-training protein supplementation during hospitalization and in the home setting for 4 weeks after discharge, on the effect on change in mobility in older medical patients. Methods Older medical patients (≥ 65 years) admitted acutely from their home to the Emergency Department were randomized to either standard care or supervised progressive strength training and an oral protein supplement during hospitalization and at home 3 days/week for 4 weeks after discharge. The primary outcome was between-group difference in change in mobility from baseline to 4 weeks after discharge assessed by the De Morton Mobility Index, which assesses bed mobility, chair mobility, static and dynamic balance, and walking. Secondary outcomes were 24-h mobility, lower extremity strength, gait speed, grip strength and activities of daily living. Results Eighty-five patients were randomized to an intervention group (N = 43) or a control group (N = 42). In the intervention group, 43% were highly compliant with the intervention. Our intention-to-treat analysis revealed no between-group difference in mobility (mean difference in change from baseline to 4 weeks, − 4.17 (95% CI − 11.09; 2.74; p = 0.24) nor in any of the secondary outcomes. The per-protocol analysis showed that the daily number of steps taken increased significantly more in the intervention group compared to the control group (mean difference in change from baseline to 4 weeks, 1033.4 steps (95% CI 4.1; 2062.7), p = 0.049, adjusted for mobility at baseline and length of stay; 1032.8 steps (95% CI 3.6; 2061.9), p = 0.049, adjusted for mobility at baseline, length of stay, and steps at baseline). Conclusions Simple supervised strength training for the lower extremities, combined with protein supplementation initiated during hospitalization and continued at home for 4 weeks after discharge was not superior to usual care in the effect on change in mobility at 4 weeks in older medical patients. For the secondary outcome, daily number of steps, high compliance with the intervention resulted in a greater daily number of steps. Less than half of the patients were compliant with the intervention indicating that a simpler intervention might be needed. Trial registration ClinicalTrials.gov, NCT01964482. Registered on 14 October 2013. Trial protocol PubMed ID (PMID), 27039381.


2019 ◽  
Author(s):  
Mette Merete Pedersen ◽  
Janne Petersen ◽  
Nina Beyer ◽  
Helle Gybel Juul-Larsen ◽  
Pia Søe Jensen ◽  
...  

Abstract Background: During hospitalization, older adults (+65) are inactive, which puts them at risk of functional decline and loss of independence. Systematic strength training can prevent loss of functional performance and combining strength training with protein supplementation may enhance the response on muscle mass and strength. However, we lack knowledge about the effect of strength training commenced during hospitalization and continued after discharge in older medical patients. This assessor-blinded, randomized study investigated the effect of a simple, supervised strength training program for the lower extremities, combined with post-training protein supplementation during hospitalization and in the home setting for 4 weeks after discharge on change in mobility in older medical patients. Methods: Older medical patients (≥65 yrs) admitted acutely from their home to the Emergency Department were randomized to either standard care or supervised progressive strength training and an oral protein supplement during hospitalization and at home 3 days/week for 4 weeks after discharge. The primary outcome was between-group difference in change in mobility from baseline to 4 weeks after discharge assessed by the De Morton Mobility Index, which assesses bed mobility, chair mobility, static and dynamic balance, and walking. Secondary outcomes were 24-hour mobility, lower extremity strength, gait speed, grip strength and Activities of Daily Living. Results: Eighty-five patients were randomized to an intervention group (N=43) or a control group (N=42). In the intervention group, 43% were highly compliant with the intervention. Our intention to treat analysis revealed no between-group difference in mobility (mean difference in change from baseline to 4 weeks: -4.17 (95 % CI: -11.09;2.74; p=0.24) nor in any of the secondary outcomes. The per protocol analysis showed that the intervention group increased significantly more in the daily number of steps taken compared to the control group (mean difference in change from baseline to 4 weeks: 1024.7 steps (95 % CI: 0.7;2048.6); p<0.05; adjusted for mobility at baseline). Conclusions: Simple supervised strength training for the lower extremities, combined with protein supplementation initiated during hospitalization and continued at home for 4 weeks after discharge was not superior to usual care on change in mobility at 4 weeks in older medical patients. For the secondary outcome, daily number of steps, high compliance with the intervention resulted in a higher daily number of steps. Less than half of the patients were compliant with the intervention indicating that a simpler intervention might be needed. Trial registration: NCT01964482, https://clinicaltrials.gov/ct2/show/NCT01964482, registration date: October 14, 2013, trial protocol: PubMed ID (PMID): 27039381.


2019 ◽  
Author(s):  
Mette Merete Pedersen ◽  
Janne Petersen ◽  
Nina Beyer ◽  
Helle Gybel Juul-Larsen ◽  
Pia Søe Jensen ◽  
...  

Abstract Background: During hospitalization, older adults (+65) are inactive, which puts them at risk of functional decline and loss of independence. Systematic strength training can prevent loss of functional performance. However, we lack knowledge about the effect of strength training commenced during hospitalization and continued after discharge in older medical patients. This assessor-blinded, randomized study investigated the effect of a simple, supervised strength training program for the lower extremities, combined with post-training protein supplementation during hospitalization and 4 weeks at home after discharge on change in mobility in older medical patients. Methods: Older medical patients (≥65 yrs) admitted acutely from their home to the Emergency Department were randomized to either standard care or supervised progressive strength training and an oral protein supplement during hospitalization and at home 3 days/week for 4 weeks after discharge. The primary outcome was between-group difference in change in mobility from baseline to 4 weeks after discharge assessed by the De Morton Mobility Index. Secondary outcomes were 24-hour mobility, lower extremity strength, gait speed, grip strength and Activities of Daily Living. Results: Eighty-five patients were randomized to the intervention (N=43) or control group (N=42). In the intervention group, 43% were highly compliant with the intervention. Our intention to treat analysis revealed no between-group difference in mobility (difference baseline to 4 weeks: -4.17 (IQR -11.09;2.74; p=0.24) nor in any of the secondary outcomes. The per protocol analysis showed that the intervention group increased significantly more in the daily number of steps taken compared to the control group (difference in change from baseline to 4 weeks: 1024.7 steps (IQR 0.7;2048.6); p<0.05; adjusted for mobility at baseline). Conclusions: Simple supervised strength training for the lower extremities, combined with protein supplementation initiated during hospitalization and continued at home for 4 weeks after discharge was not superior to usual care on change in mobility at 4 weeks in older medical patients. For the secondary outcome, daily number of steps, high compliance with the intervention resulted in a higher daily number of steps. Less than half of the patients were compliant with the intervention indicating that a simpler intervention might be needed. Trial registration: NCT01964482, https://clinicaltrials.gov/ct2/show/NCT01964482, registration date: October 14, 2013, trial protocol: PubMed ID (PMID): 27039381.


2017 ◽  
Vol 31 (9) ◽  
pp. 1189-1200 ◽  
Author(s):  
Jane Wu ◽  
Steven G Faux ◽  
John Estell ◽  
Stephen Wilson ◽  
Ian Harris ◽  
...  

Objective: To investigate the impact of an in-reach rehabilitation team for patients admitted after road trauma. Design: Randomised control trial of usual care versus early involvement of in-reach rehabilitation team. Telephone follow-up was conducted by a blind assessor at three months for those with minor/moderate injuries and six months for serious/severe injuries. Setting: Four participating trauma services in New South Wales, Australia. Subjects: A total of 214 patients admitted during 2012-2015 with a length of stay of at least five days. Intervention: Provision of rehabilitation services in parallel with ward based therapy using an in-reach team for the intervention group. The control group could still access the ward based therapy (usual care). Main measures: The primary outcome was acute length of stay. Secondary outcomes included percentage requiring inpatient rehabilitation, function (Functional Independence Measure and Timed Up and Go Test), psychological status (Depression Anxiety and Stress Score 21), pain (Orebro Musculoskeletal Pain Questionnaire) and quality of life (Short Form-12 v2). Results: Median length of stay in acute care was 13 days (IQR 8-21). The intervention group, compared to the control group, received more physiotherapy and occupational therapy sessions (median number of sessions 16.0 versus 11.5, P=0.003). However, acute length of stay did not differ between the intervention and control groups (median 15 vs 12 days, P=0.37). There were no significant differences observed in the secondary outcomes at hospital discharge and follow-up. Conclusion: No additional benefit was found from the routine use of acute rehabilitation teams for trauma patients over and above usual care.


2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Lise Vilstrup Holm ◽  
Dorte Ejg Jarbøl ◽  
Henrik Wulff Christensen ◽  
Jens Søndergaard ◽  
Lise Hestbæk

Abstract Background Chiropractic care is commonly used to treat infantile colic. However large trials with parental blinding are missing. Therefore, the purpose of this study is to evaluate the effect of chiropractic care on infantile colic. Method This is a multicenter, single-blind randomized controlled trial conducted in four Danish chiropractic clinics, 2015–2019. Information was distributed in the maternity wards and by maternal and child health nurses. Children aged 2–14 weeks with unexplained excessive crying were recruited through home visits and randomized (1:1) to either chiropractic care or control group. Both groups attended the chiropractic clinic twice a week for 2 weeks. The intervention group received chiropractic care, while the control group was not treated. The parents were not present in the treatment room and unaware of their child’s allocation. The primary outcome was change in daily hours of crying before and after treatment. Secondary outcomes were changes in hours of sleep, hours being awake and content, gastrointestinal symptoms, colic status and satisfaction. All outcomes were based on parental diaries and a final questionnaire. Results Of 200 recruited children, 185 completed the trial (treatment group n = 96; control group n = 89). Duration of crying in the treatment group was reduced by 1.5 h compared with 1 h in the control group (mean difference − 0.6, 95% CI − 1.1 to − 0.1; P = 0.026), but when adjusted for baseline hours of crying, age and chiropractic clinic, the difference was not significant (P = 0.066). The proportion obtaining a clinically important reduction of 1 h of crying was 63% in the treatment group and 47% in the control group (p = 0.037), and NNT was 6.5. We found no effect on any of the secondary outcomes. Conclusion Excessive crying was reduced by half an hour in favor of the group receiving chiropractic care compared with the control group, but not at a statistically significant level after adjustments. From a clinical perspective, the mean difference between the groups was small, but there were large individual differences, which emphasizes the need to investigate if subgroups of children, e.g. those with musculoskeletal problems, benefit more than others from chiropractic care. Trial registration Clinical Trials NCT02595515, registered 2 November 2015


Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Tzikas ◽  
A Samaras ◽  
A Kartas ◽  
D Vasdeki ◽  
G Fotos ◽  
...  

Abstract Background Oral anticoagulation (OAC) is paramount to effective thromboprophylaxis; yet adherence to OAC remains largely suboptimal in patients with atrial fibrillation (AF). Purpose We aimed to assess the impact of an educational, motivational intervention on the adherence to OAC in patients with non-valvular AF. Methods Hospitalised patients with non-valvular AF who received OAC were randomly assigned to usual medical care or a proactive intervention, comprising motivational interviewing and tailored counseling on medication adherence. The primary study outcome was adherence to OAC at 1-year, evaluated as Proportion of Days Covered (PDC) by OAC regimens and assessed through nationwide prescription registers. Secondary outcomes included the rate of persistence to OAC, gaps in treatment, proportion of VKA-takers with labile INR (defined as time to therapeutic range&lt;70%) and clinical events. Results A total of 1009 patients were randomised, 500 in the intervention group and 509 in the control group. At 1-year follow-up, 77.2% (386/500) of patients in the intervention group had good adherence (PDC&gt;80%), compared with 55% (280/509) in the control group (adjusted odds ratio 2.84, 95% confidence interval 2.14–3.75; p&lt;0.001). Mean PDC±SD was 0.85±0.26 and 0.75±0.31, respectively (p&lt;0.001). Patients that received the intervention were more likely to persist in their OAC therapy at 1 year, while usual medical care was associated with more major (≥3 months) treatment gaps [Figure]. Among 212 VKA-takers, patients in the intervention group were less likely to have labile INR compared with those in the control group [21/120 (17.1%) vs 34/92 (37.1%), OR 0.33 95% CI 1.15–0.72, p=0.005]. Clinical events over a median follow-up period of 2 years occurred at a numerically lower, yet non-significant, rate in the intervention group [Table]. Conclusions In patients receiving OAC therapy for non-valvular AF, a motivational intervention significantly improved patterns of medication adherence, without significantly affecting clinical outcomes. Primary and secondary outcomes Funding Acknowledgement Type of funding source: None


Author(s):  
Khawla Loubani ◽  
Rachel Kizony ◽  
Uzi Milman ◽  
Naomi Schreuer

Background: Women after breast cancer (BC) cope with decreased daily participation and quality of life (QOL) due to physical, cognitive, and emotional symptoms. This study examined a hybrid occupation-based intervention, Managing Participation with Breast Cancer (MaP-BC), to improve daily participation in their meaningful activities. Methods: Thirty-five women after BC phase were randomly allocated to the MaP-BC intervention (n = 18) or control (n = 17) group (standard care only). Assessments were administered at baseline (T1), 6-week (T2), and 12-week (T3) post-T1. Main outcome: perceived performance and performance-satisfaction with meaningful activities according to the Canadian Occupational Performance Measure. Secondary outcomes: retained activity levels (Activity Card Sort), QOL (Functional Assessment of Cancer Therapy-Breast), cognitive abilities (Montreal Cognitive Assessment and Behavior Rating Inventory of Executive Function), and upper-extremity functioning (Disability of Arm, Shoulder, Hand). Results showed significant interaction (group x time) effects for the primary outcome in performance, F(2,66) = 29.54, p = 0.001, ɳP2 = 0.472, and satisfaction, F(2,66) = 37.15, p = 0.000, ɳP2 = 0.530. The intervention group improved more in performance, t = 5.51, p = 0.0001, d = 1.298, and satisfaction, t = −5.32, p = 0.0001, d = 1.254, than the control group between T1 and T2. Secondary outcomes demonstrated within-group improvements. Conclusion: MaP-BC, a comprehensive occupation-based hybrid intervention tailored to women’s functional daily needs after BC, improved participation in meaningful activities within a short period.


SLEEP ◽  
2020 ◽  
Vol 43 (11) ◽  
Author(s):  
Liora Kempler ◽  
Louise A Sharpe ◽  
Nathaniel S Marshall ◽  
Delwyn J Bartlett

Abstract Study Objectives Poor sleep is commonly problematic during pregnancy and postpartum and is associated with depression. This trial investigated the efficacy of prenatal brief, group sleep psychoeducation in improving postpartum maternal sleep, and depression. Methods A total of 215 healthy expectant first-time mothers were cluster randomized (1:1) to receive either a 2 × 1.5 h psychoeducation intervention and a set of booklets, or a set of booklets only. Participants completed questionnaires during pregnancy (pre-intervention), and 6 weeks and 4 months postpartum. A post hoc subset of questionnaires was collected at 10 months postpartum. The primary hypothesis was the intervention group would have improved postpartum sleep quality, and reduced levels of insomnia symptoms, fatigue, and daytime sleepiness compared to the control group. Secondary outcomes included depression, anxiety, and stress. Results Linear mixed model analyses failed to confirm a group by time interaction on primary or secondary outcomes across all time points. There was no effect of the intervention on outcomes at 6 weeks, or 10 months postpartum. A significant time by group interaction was found at 4 months, favoring the intervention for sleep quality (p = 0.03) and insomnia symptoms (p = 0.03), but not fatigue or daytime sleepiness. Conclusions Prenatal sleep psychoeducation did not produce a sustained effect on maternal sleep throughout the postpartum period. There was little evidence of benefits on depressive symptoms. Clinical Trial Registration ACTRN12611000859987


2011 ◽  
Vol 9 (4) ◽  
pp. 401-406 ◽  
Author(s):  
Dana Lustbader ◽  
Renee Pekmezaris ◽  
Michael Frankenthaler ◽  
Rajni Walia ◽  
Frederick Smith ◽  
...  

AbstractObjective:The purpose of this study was to assess the impact of a palliative medicine consultation on medical intensive care unit (MICU) and hospital length of stay, Do Not Resuscitate (DNR) designation, and location of death for MICU patients who died during hospitalization.Method:A comparison of two retrospective cohorts in a 17-bed MICU in a tertiary care university-affiliated hospital was conducted. Patients admitted to the MICU between January 1, 2003 and June 30, 2004 (N = 515) were compared to MICU patients who had had a palliative medicine consultation between January 1, 2005 and June 1, 2009 (N = 693). To control for disease severity, only patients in both cohorts who died during their hospitalization were considered for this study.Results:Palliative medicine consultation reduced time until death during the entire hospitalization (log-rank test,p < 0.01). Time from MICU admission until death was also reduced (log-rank test,p < 0.01), further demonstrating the impact of the palliative care consultation on the duration of dying for hospitalized patients. The intervention group contained a significantly higher percentage of patients with a DNR designation at death than did the control group (86% vs. 68%, χ2test,p < 0.0001).Significance of results:Palliative medicine consultation is associated with an increased rate of DNR designation and reduced time until death. Patients in the intervention group were also more likely to die outside the MICU as compared to controls in the usual care group.


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