Early mobilization and quality of life after stroke

ObjectiveTo determine whether early and more frequent mobilization after stroke affects health-related quality of life.MethodsA Very Early Rehabilitation Trial (AVERT) was an international, multicenter (56 sites), phase 3 randomized controlled trial, spanning 2006–2015. People were included if they were aged ≥18 years, presented within 24 hours of a first or recurrent stroke (ischemic or hemorrhagic), and satisfied preordained physiologic criteria. Participants were randomized to usual care alone or very early and more frequent mobilization in addition to usual care. Quality of life at 12 months was a prespecified secondary outcome, evaluated using the Assessment of Quality of Life 4D (AQoL-4D). This utility-weighted scale has scores ranging from −0.04 (worse than death) to 1 (perfect health). Participants who died were assigned an AQoL-4D score of 0.ResultsNo significant difference in quality of life at 12 months between intervention (median 0.47, interquartile range [IQR] 0.07–0.81) and usual care (median 0.49, IQR 0.08–0.81) groups was identified (p = 0.86), nor were there any group differences across the 4 AQoL-4D domains. The same lack of group difference in quality of life was observed at 3 months. When cohort data were analyzed (both groups together), quality of life was strongly associated with acute length of stay, independence in activities of daily living, cognitive function, depressive symptoms, and anxiety symptoms (all p < 0.001). Quality of life in AVERT participants was substantially lower than population norms, and the gap increased with age.ConclusionsEarlier and more frequent mobilization after stroke did not influence quality of life.Clinical trial registrationanzctr.org.au; ACTRN12606000185561Classification of evidenceThis study provides Class II evidence that for people with stroke, earlier and more frequent mobilization did not influence quality of life over the subsequent year.

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Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill

BMJ Open ◽

10.1136/bmjopen-2017-017393 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017393 ◽

Cited By ~ 10

Author(s):

Marc R Nickels ◽

Leanne M Aitken ◽

James Walsham ◽

Adrian G Barnett ◽

Steven M McPhail

Keyword(s):

Quality Of Life ◽

Critical Illness ◽

Randomised Controlled Trial ◽

Usual Care ◽

Hospital Discharge ◽

Controlled Trial ◽

Secondary Outcome ◽

Surgical Intensive Care Unit ◽

Randomised Controlled

IntroductionIn-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown.Methods and analysisA single-centre randomised controlled trial in a mixed medical-surgical intensive care unit (ICU) will be conducted. Adult patients (n=68) who are expected to be mechanically ventilated for more than 48 hours and remain in ICU for a further 48 hours from recruitment will be randomly allocated into either (1) a usual care group or (2) a group that receives usual care and additional in-bed cycling sessions. The primary outcome is change in rectus femoris cross-sectional area at day 10 in comparison to baseline measured by blinded assessors. Secondary outcome measures include muscle strength, incidence of ICU-acquired weakness, handgrip strength, time to achieve functional milestones (sitting out of bed, walking), Functional Status Score in ICU, ICU Mobility Scale, 6 min walk test 1 week post-ICU discharge, incidence of delirium and quality of life (EuroQol Five Dimensions questionnaire Five Levels scale). Quality of life assessments will be conducted post-ICU admission at day 10, 3 and 6 months after acute hospital discharge. Participants in the intervention group will complete an acceptability of intervention questionnaire.Ethics and disseminationAppropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness.Trial registration numberThis trial has been prospectively registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12616000948493); Pre-results.

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Comparing the Effect of Dienogest and OCPS on Pain and Quality of Life in Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Trial

Archives of Iranian Medicine ◽

10.34172/aim.2021.96 ◽

2021 ◽

Vol 24 (9) ◽

pp. 670-677

Author(s):

Gelareh Niakan ◽

Samaneh Rokhgireh ◽

Majid Ebrahimpour ◽

Abolfazl Mehdizadeh Kashi

Keyword(s):

Quality Of Life ◽

Pelvic Pain ◽

Controlled Trial ◽

Primary Objective ◽

Secondary Outcome ◽

Double Blind ◽

Oral Contraceptive Pills ◽

Significant Difference ◽

The Difference

Background: Endometriosis is an estrogen-dependent disease that adversely affects women’s quality of life (QOL). We aimed to compare the effect of dienogest and oral contraceptive pills (OCPs) on pain and QOL in women with endometriosis. Methods: This randomized double-blind trial was conducted at Rasoul-e-Akram hospital, affiliated to Iran University of Medical Sciences, Tehran, Iran, from March 2018 to March 2020, on women with severe endometriosis confirmed by laparoscopic surgery. Ninety patients were randomly given either dienogest (Vissane 2 mg tablet; n = 30), or OCPs (LD; n = 30), or placebo (n = 30) daily for 12 weeks. The primary objective of this study was to evaluate the patient’s pain including dyspareunia, dysuria, dyschezia, and pelvic pain. The secondary outcome was considered as a change in patients’ QOL score. Results: The mean age of population was 32.99 ± 7.1 years. There was no significant difference in the three groups regarding baseline characteristics. Pelvic pain was significantly reduced, while the effect of medication on dysuria and dyschezia was not significant. The overall QOL score between the control and dienogest (P = 0.02) and OCPs groups (P = 0.001) was significantly different; however, the difference was not significant between the two intervention groups Conclusion: The finding of the present study revealed that there is no difference in the efficacy of dienogest and OCPs in management of pain and the QOL. But there was a significant difference between the placebo and intervention groups.

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Evaluating the provision of Further Enabling Care at Home (FECH+) for informal caregivers of older adults discharged home from hospital: protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-046600 ◽

2021 ◽

Vol 11 (6) ◽

pp. e046600

Author(s):

Anne-Marie Hill ◽

Rachael Moorin ◽

Susan Slatyer ◽

Christina Bryant ◽

Keith Hill ◽

...

Keyword(s):

Quality Of Life ◽

Older Adults ◽

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Informal Caregivers ◽

Care Recipient ◽

Care At Home ◽

Randomised Controlled

IntroductionThere are personal and societal benefits from caregiving; however, caregiving can jeopardise caregivers’ health. The Further Enabling Care at Home (FECH+) programme provides structured nurse support, through telephone outreach, to informal caregivers of older adults following discharge from acute hospital care to home. The trial aims to evaluate the efficacy of the FECH+ programme on caregivers’ health-related quality of life (HRQOL) after care recipients’ hospital discharge.Methods and analysisA multisite, parallel-group, randomised controlled trial with blinded baseline and outcome assessment and intention-to-treat analysis, adhering to Consolidated Standards of Reporting Trials guidelines will be conducted. Participants (N=925 dyads) comprising informal home caregiver (18 years or older) and care recipient (70 years or older) will be recruited when the care recipient is discharged from hospital. Caregivers of patients discharged from wards in three hospitals in Australia (one in Western Australia and two in Queensland) are eligible for inclusion. Participants will be randomly assigned to one of the two groups. The intervention group receive the FECH+ programme, which provides structured support and problem-solving for the caregiver after the care recipient’s discharge, in addition to usual care. The control group receives usual care. The programme is delivered by a registered nurse and comprises six 30–45 min telephone support sessions over 6 months. The primary outcome is caregivers’ HRQOL measured using the Assessment of Quality of Life—eight dimensions. Secondary outcomes include caregiver preparedness, strain and distress and use of healthcare services. Changes in HRQOL between groups will be compared using a mixed regression model that accounts for the correlation between repeated measurements.Ethics and disseminationParticipants will provide written informed consent. Ethics approvals have been obtained from Sir Charles Gairdner and Osborne Park Health Care Group, Curtin University, Griffith University, Gold Coast Health Service and government health data linkage services. Findings will be disseminated through presentations, peer-reviewed journals and conferences.Trial registration numberACTRN12620000060943.

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Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042627 ◽

2021 ◽

Vol 11 (3) ◽

pp. e042627

Author(s):

María Reina-Bueno ◽

María del Carmen Vázquez-Bautista ◽

Inmaculada C Palomo-Toucedo ◽

Gabriel Domínguez-Maldonado ◽

José Manuel Castillo-López ◽

...

Keyword(s):

Quality Of Life ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Controlled Trial ◽

Secondary Outcome ◽

Foot Orthoses ◽

Systemic Lupus ◽

Custom Made ◽

Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

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Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

10.31487/j.jicoa.2021.04.01.sup ◽

2021 ◽

Author(s):

Maj Siercke ◽

Sanne Pagh Moller ◽

Lau Caspar Thygesen ◽

Henrik Sillesen ◽

Dorthe Overgaard

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Clinical Trial ◽

Mixed Methods ◽

Usual Care ◽

Randomized Clinical Trial ◽

Intermittent Claudication ◽

Walking Distance ◽

Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

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A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein

Phlebology The Journal of Venous Disease ◽

10.1177/0268355519885221 ◽

2019 ◽

Vol 35 (5) ◽

pp. 305-315 ◽

Cited By ~ 2

Author(s):

Sandip Nandhra ◽

Tom Wallace ◽

Joseph El-Sheikha ◽

Daniel Carradice ◽

Ian Chetter

Keyword(s):

Quality Of Life ◽

General Anaesthesia ◽

Saphenous Vein ◽

Primary Outcome ◽

Great Saphenous Vein ◽

Bodily Pain ◽

Secondary Outcome ◽

Surgical Ligation ◽

Significant Difference

Introduction Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. Methods Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. Results A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20–54) mm vs. (GA alone) 56 (24–70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6–17.9) vs. 4.3 (IQR 2.7–7.9) P = 0.004). Conclusion The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39

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Yoga in women undergoing treatment for breast cancer: Impact on quality of life in a randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.527 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 527-527

Author(s):

Nita S. Nair ◽

Nishu Singh Goel ◽

Rohini W Hawaldar ◽

Shabina Siddique ◽

Vani Parmar ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Adjuvant Therapy ◽

Low Cost ◽

Controlled Trial ◽

Statistical Significance ◽

Disease Free Survival ◽

Complementary Therapy ◽

Significant Difference

527 Background: Yoga has been tested in multiple small-randomized studies for its impact on quality of life (QOL) on breast cancer (BC). We propose to study the effect of yoga on disease free survival as the primary endpoint in women with operable breast cancer. (Study methodology details refer to NCT02161900). Methods: Women with non-metastatic BC were randomized to yoga and conventional exercise (YCE) versus conventional exercise only (CE) in addition to standard therapy. Over and above documentation of recurrence and death, QOL was assessed in these women using the EORTC QLQC30, BR23, Brief fatigue inventory (BFI), Visual pain scores (VPS) and a spirituality questionnaire (SQ). EORTC QLQ was assessed at baseline (BL), 6-9 months (mo), 18-21 mo. BFI and VPS at BL, 6-8 mo and 12-15 mo and SQ at BL and 12-15 mo. We report the first interim analysis of QOL in 605 patients randomized to the study with atleast 1 year of follow up. The groups were balanced in both arms with respect to clinico-pathological factors. Results: At 6-9 mo (completion of adjuvant therapy), there was no significant difference in global QOL scores (p = 0.08), however 52% women on YCE showed an improvement from baseline compared to 42% in CE. At 18-21 mo emotional function scores were better in YCE (p = 0.002); with lesser systemic side effects in YCE arm (44% vs 56% p = NS). The median score of fatigue after adjuvant therapy measured by QLQ C30 was lower in YCE (17.37vs22.22, p = 0.003) which was similar to that observed by BFI at 12-15 mo (1.6vs 2, p = 0.04). Also in YCE there was lower reporting of detriment in general activity (41%vs 59%) and mood (34%vs66%) (p = NS). In VPS at 12-15mo, the median scores for pain intensity (p = 0.042), pain on movement (p = 0.038), pain on mobilization (p = 0.008) were lower in YCE. Lastly SQ assessed spirituality and showed no difference, but less deterioration compared to baseline scores in YCE. Conclusions: Yoga did not show a significant difference in global QOL but had a major benefit reaching statistical significance in fatigue, emotional score and pain. Yoga is a low-risk, low-cost complementary therapy that may improve compliance to therapy by improving parameters that can affect day-to-day activity in women with breast cancer. Clinical trial information: NCT02161900.

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TIRED: A randomised controlled trial evaluating efficacy of cognitive behavior therapy and graded exercise therapy in severely fatigue patients with advanced cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.34_suppl.183 ◽

2018 ◽

Vol 36 (34_suppl) ◽

pp. 183-183

Author(s):

Hanneke Poort ◽

Marlies Peters ◽

Winette T.A. Van Der Graaf ◽

Pythia Nieuwkerk ◽

Agnes W Van de Wouw ◽

...

Keyword(s):

Quality Of Life ◽

Usual Care ◽

Advanced Cancer ◽

Severe Fatigue ◽

Graded Exercise Therapy ◽

Significant Difference ◽

Eortc Qlq C30 ◽

Secondary Outcomes ◽

Eortc Qlq

183 Background: Patients with advanced, metastatic cancer frequently suffer from severe fatigue. We assessed the effect of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) on fatigue during cancer treatment with palliative intent. Methods: This randomized study took place between Jan 1, 2013 and Sep 1, 2017 at Radboud University Medical Center (Nijmegen, Netherlands). We enrolled adult patients from nine medical oncology clinics. Eligible patients had advanced cancer and reported severe fatigue (Checklist Individual Strength, subscale fatigue severity [CIS fatigue] ≥ 35) during cancer treatment. Participants were randomized to CBT, GET, or usual care (1:1:1 ratio, using a computer-generated sequence, stratified by study site and minimized for sex). We measured fatigue (CIS fatigue and European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-Core 30 [EORTC-QLQ-C30] fatigue), quality of life, emotional functioning, physical functioning (all by EORTC-QLQ-C30), and functional impairments (Sickness Impact Profile [SIP8]) at baseline, 14, 18, and 26 weeks. The primary outcome was CIS fatigue at 14 weeks; secondary outcomes included scores for the aforementioned scales. We registered the trial with TrialRegister.nl (NTR3812). Results: 134 participants completed baseline measures (46 CBT, 42 GET, 46 usual care); 126 completed assessment at 14 weeks. There was a significant difference in CIS fatigue scores between CBT and usual care (-7.22, 97.5% CI -12.73 to -1.72; p = .003, d= 0.72), but no significant difference between GET and usual care (-4.70, -10.24 to 0.85, p = .057, d= 0.44). Secondary outcomes showed significant differences for EORTC-QLQ-C30 fatigue (-13.05 [95% CI -22.12 to -3.97]; p = 0.005), quality of life (10.15 [2.37 to 17.93]; p = 0.11), and physical functioning (7.10 [0.48 to 13.72]; p = 0.036), but not for emotional functioning or SIP8 functional impairments (p's > 0.05). There were no significant differences in secondary outcomes between GET and usual care. Conclusions: The findings support CBT for severe fatigue in patients with advanced cancer during treatment. Clinical trial information: NTR3812.

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Biopsy versus resection in the management of malignant gliomas: a systematic review and meta-analysis

Journal of Neurosurgery ◽

10.3171/2009.7.jns09758 ◽

2010 ◽

Vol 112 (5) ◽

pp. 1020-1032 ◽

Cited By ~ 31

Author(s):

Abraham Tsitlakidis ◽

Nicolas Foroglou ◽

Christos A. Venetis ◽

Ioannis Patsalas ◽

Athanasios Hatzisotiriou ◽

...

Keyword(s):

Quality Of Life ◽

Systematic Review ◽

Overall Survival ◽

Malignant Glioma ◽

Controlled Trial ◽

Meta Analysis ◽

Malignant Gliomas ◽

Karnofsky Performance Scale ◽

Significant Difference

Object The aim of this study was to answer the question whether quality of life and progression-free and overall survival are increased in adults with supratentorial malignant glioma who are treated with cytoreductive resection as compared with those who only undergo biopsy. Methods A literature search of the electronic databases MEDLINE, EMBASE, and CENTRAL was performed to identify relevant studies published before May 2008. Hand-searching of reference lists of the identified studies and relevant review articles was also performed. A study was considered eligible, regardless of study design (prospective or retrospective), if: 1) quality of life and/or progression-free and/or overall survival was compared among adult patients undergoing biopsy or resection, and 2) patient age and Karnofsky Performance Scale scores were not significantly different among the 2 groups compared. Results One randomized controlled trial and 4 retrospective studies (involving a total of 1111 patients) were found eligible for this systematic review. A meta-analysis of the eligible studies demonstrated a significant increase in overall survival in the patients treated with resection instead of biopsy (hazard ratio 0.61, 95% CI 0.52–0.71, p < 0.0001, fixed-effect model). Although statistical pooling was not feasible, the available data suggest that quality of life was increased in patients treated with resection rather than biopsy, while there did not seem to be any significant difference in progression-free survival between the 2 groups. Conclusions Based on the best available evidence, it appears that cytoreductive resection in adults with supratentorial malignant glioma is associated with improved overall survival as compared with biopsy. However, well-designed prospective studies are needed for more solid conclusions to be drawn.

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