scholarly journals Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation

Stroke ◽  
2020 ◽  
Vol 51 (9) ◽  
pp. 2639-2648 ◽  
Author(s):  
Tara D. Klassen ◽  
Sean P. Dukelow ◽  
Mark T. Bayley ◽  
Oscar Benavente ◽  
Michael D. Hill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Controlled Trial ◽  
Critical Time ◽  
Inpatient Rehabilitation ◽  
Post Evaluation ◽  
Walking Recovery ◽  
Higher Doses ◽  
Walking Endurance

Background and Purpose: We investigated the effect of higher therapeutic exercise doses on walking during inpatient rehabilitation, typically commencing 1 to 4 weeks poststroke. Methods: This phase II, blinded-assessor, randomized controlled trial recruited from 6 Canadian inpatient rehabilitation units, between 2014 and 2018. Subjects (n=75; 25/group) were randomized into: control (usual care) physical therapy: typically, 1 hour, 5 days/week; Determining Optimal Post-Stroke Exercise (DOSE1): 1 hour, 5 days/week, more than double the intensity of Control (based on aerobic minutes and walking steps); and DOSE2: 2 hours, 5 days/week, more than quadruple the intensity of Control, each for 4 weeks duration. The primary outcome, walking endurance at completion of the 4-week intervention (post-evaluation), was compared across these groups using linear regression. Secondary outcomes at post-evaluation, and longitudinal outcomes at 6 and 12-month evaluations, were also analyzed. Results: Both DOSE1 (mean change 61 m [95% CI, 9–113], P =0.02) and DOSE2 (mean change 58 m, 6–110, P =0.03) demonstrated greater walking endurance compared with Control at the post-evaluation. Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control. Longitudinal analyses revealed that improvements in walking endurance from the DOSE intervention were retained during the 1-year follow-up period over usual care. Conclusions: This study provides the first preliminary evidence that patients with stroke can improve their walking recovery and quality of life with higher doses of aerobic and stepping activity within a critical time period for neurological recovery. Furthermore, walking endurance benefits achieved from a 4-week intervention are retained over the first-year poststroke. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01915368.

scholarly journals 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 ◽  
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.

Acupuncture for Cancer-Related Fatigue in Patients With Breast Cancer: A Pragmatic Randomized Controlled Trial

2012 ◽  
Vol 30 (36) ◽  
pp. 4470-4476 ◽  
Author(s):  
Alexander Molassiotis ◽  
Joy Bardy ◽  
Jennifer Finnegan-John ◽  
Peter Mackereth ◽  
David W. Ryder ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Usual Care ◽  
Controlled Trial ◽  
Well Being ◽  
Anxiety And Depression ◽  
Cancer Related Fatigue ◽  
General Fatigue ◽  
Acupuncture Effect

Purpose We aimed to assess the effectiveness of acupuncture for cancer-related fatigue (CRF) in patients with breast cancer. Patients and Methods We conducted a pragmatic, randomized controlled trial comparing acupuncture with enhanced usual care. Three hundred two outpatients with breast cancer participated. We randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care (random assignment of 1:3 respectively) with minimization controlling for baseline general fatigue and maintenance treatment. Treatment was delivered by acupuncturists once a week for 6 weeks through needling three pairs of acupoints. The usual care group received a booklet with information about fatigue and its management. Primary outcome was general fatigue at 6 weeks, measured with the Multidimensional Fatigue Inventory (MFI). Other measurements included the Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy–General quality-of-life scale, and expectation of acupuncture effect. Analyses were by intention to treat. Results Two hundred forty-six of 302 patients randomly assigned provided complete data at 6 weeks. The difference in the mean General Fatigue score, between those who received the intervention and those who did not, was −3.11 (95% CI, −3.97 to −2.25; P < .001). The intervention also improved all other fatigue aspects measured by MFI, including Physical Fatigue and Mental Fatigue (acupuncture effect, −2.36 and −1.94, respectively; both at P < .001), anxiety and depression (acupuncture effect, −1.83 and −2.13, respectively; both at P < .001), and quality of life (Physical Well-Being effect, 3.30; Functional Well-Being effect, 3.57; both at P < .001; Emotional Well-Being effect, 1.93; P = .001; and Social Functioning Well-Being effect, 1.05; P < .05). Conclusion Acupuncture is an effective intervention for managing the symptom of CRF and improving patients' quality of life.

scholarly journals The effect of graded activity and pain education (GAPE) - an early post-surgical rehabilitation programme after lumbar spinal fusion: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Heidi Tegner ◽  
Bente Appel Esbensen ◽  
Marius Henriksen ◽  
Rachid Bech-Azeddine ◽  
Mari Lundberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Sedentary Behaviour ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Physically Active ◽  
Fear Of Movement ◽  
Post Surgery ◽  
Lumbar Spinal

Abstract BackgroundPatients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objectives are to examine the effect of GAPE on, respectively, disability, pain, fear of movement, self-efficacy for exercise and health-related quality of life.MethodsThe study is an RCT planned to include 144 patients undergoing LSF at 1-2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient’s self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery), and at three and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery), and at three, six, and 12 months post-surgery. DiscussionWe hypothesize that, compared with the “usual care group”, GAPE will primarily lead to a significantly reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient’s self-efficacy for exercise and quality of life. Trial registration: www.clinicaltrials.gov (NCT04103970), 24 September 2019

scholarly journals Using a quality of life (QoL)-monitor: preliminary results of a randomized trial in Dutch patients with early breast cancer

2020 ◽  
Vol 29 (11) ◽  
pp. 2961-2975
Author(s):  
R. T. Lugtenberg ◽  
M. J. Fischer ◽  
F. de Jongh ◽  
K. Kobayashi ◽  
K. Inoue ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Usual Care ◽  
Early Breast Cancer ◽  
Patient Management ◽  
Illness Perceptions ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Care Needs

Abstract Purpose The diagnosis and treatment of cancer negatively affect patients’ physical, functional and psychological wellbeing. Patients’ needs for care cannot be addressed unless they are recognized by healthcare providers (HCPs). The use of quality of life (QoL) assessments with feedback to HCPs might facilitate the identification and discussion of QoL-topics. Methods 113 patients with stage I–IIIB breast cancer treated with chemotherapy were included in this randomized controlled trial. Patients were randomly allocated to receive either usual care, or usual care with an intervention consisting of a QoL-monitor assessing QoL, distress and care needs before every chemotherapy cycle visit. Patients completed questionnaires regarding QoL, illness perceptions, self-efficacy, and satisfaction with communication. From the 2nd visit onwards, patients in the intervention arm and their HCPs received a copy of the QoL overview and results were shown in patients’ medical files. Audio-recordings and patients’ self-reports were used to investigate effects on communication, patient management and patient-wellbeing. A composite score for communication was calculated by summing the number of QoL-topics discussed during each consultation. Results Use of the QoL-monitor resulted in a higher communication score (0.7 topics increase per visit, p = 0.04), especially regarding the disease-specific and psychosocial issues (p < 0.01). There were no differences in patient management, QoL, illness perceptions or distress. Patients in the experimental arm (n = 60) had higher scores on satisfaction with communication (p < 0.05). Conclusions Use of a QoL-monitor during chemotherapy in patients with early breast cancer might result in a more frequent discussion of QoL-topics, associated with high levels of patients’ satisfaction.

scholarly journals The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion—study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Heidi Tegner ◽  
Bente Appel Esbensen ◽  
Marius Henriksen ◽  
Rachid Bech-Azeddine ◽  
Mari Lundberg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Sedentary Behaviour ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Physically Active ◽  
Fear Of Movement ◽  
Post Surgery ◽  
Lumbar Spinal

Abstract Background Patients with chronic low back pain undergoing lumbar spinal fusion (LSF) are physically inactive and thereby at risk of poor health. Barriers to being physically active need to be acknowledged in post-surgical rehabilitation. The primary objective of this randomized controlled trial (RCT) is to examine the effect of an early active intervention consisting of graded activity and pain education (GAPE) on sedentary behaviour in a population of patients undergoing LSF. The secondary objective is to examine the effect of GAPE on disability, pain, fear of movement, self-efficacy for exercise, and health-related quality of life. Methods The study is an RCT planned to include 144 patients undergoing LSF at 1–2 levels for low back pain caused by degeneration of the lumbar spine. The patients will be randomly assigned to receive either usual care or usual care plus GAPE. GAPE consists of nine individual physiotherapist-guided sessions over a 10-week period. The overall purpose is to reduce sedentary behaviour, by educating the patient about pain and, based on a cognitive behavioural perspective, gradually strengthen the patient’s self-efficacy to be physically active and reduce fear of movement. The physiotherapist will plan the intervention in collaboration with the patient. Based on a semi-structured interview and observations of the patient in their home, they will set individually functional goals. The primary outcome will be a reduction in sedentary behaviour, measured by an accelerometer at baseline (pre-surgery) and at 3 and 12 months post-surgery. Secondary outcomes will include disability, pain, fear of movement, self-efficacy for exercise, and quality of life. Secondary outcome data will be collected at baseline (pre-surgery) and at 3, 6 and 12 months post-surgery. Discussion We hypothesize that, compared with the “usual care group”, GAPE will primarily lead to a significant reduction in sedentary behaviour, and secondarily a reduction in disability, pain intensity, and fear of movement; further, it will increase the patient’s self-efficacy for exercise and quality of life. Trial registration www.clinicaltrials.gov NCT04103970, Registered on 24 September 2019

scholarly journals Effect of Baduanjin Exercise Intervention on Cognitive Function and Quality of Life in Women With Breast Cancer Receiving Chemotherapy: Study Protocol of A Randomized Controlled Trial

2021 ◽  
Author(s):  
Xiaolin Wei ◽  
Ruzhen Yuan ◽  
Yongmei Jin ◽  
Shu Li ◽  
Mingyue Wang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cognitive Function ◽  
Usual Care ◽  
Exercise Intervention ◽  
Early Stage ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
To Receive

Abstract Background: Cancer-related cognitive impairments (CRCI) are frequently reported by cancer patients before and after medical treatment. However, there are no effective interventions to or manage cognitive problem for women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancerundergoing chemotherapy. Method/design: A single-blinded, randomized controlled trial was designed. The trail will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomized(1:1) to receive either supervised Baduanjin exercise intervention (at least 5 times/week and 30min for each time) plus usual care or usual care alone for three months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures such as subjective and objective cognitive function, symptoms (fatigue, depressive symptoms, anxiety) and health-related quality of life at baseline(T0), 8 weeks(T1) and 12 weeks(T3). Primary cognitive outcomes will be reported descriptively while effect sizes and 95% confidence intervals (CIs) will be calculated for cognitive measures. The collected data will be analysed using an intention-to-treat principle. Discussion: This study is the first-known randomized clinical trial to investigate whether Baduanjin exercise plus usual care superior to usual care alone on cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive function and promote survivorship care among breast cancer survivors.Trial registration: Chinese Clinical Trial Registry(ChiCTR), ID: ChiCTR 2000033152. Registered on 22 May 2020.

scholarly journals A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol

2019 ◽  
Vol 5 (4) ◽  
pp. 00186-2019 ◽  
Author(s):  
Caroline Wright ◽  
Simon P. Hart ◽  
Victoria Allgar ◽  
Anne English ◽  
Flavia Swan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Usual Care ◽  
Study Protocol ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Controlled

IntroductionIdiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes breathlessness and cough that worsen over time, limiting daily activities and negatively impacting quality of life. Although treatments are now available that slow the rate of lung function decline, trials of these treatments have failed to show improvement in symptoms or quality of life. There is an immediate unmet need for evidenced-based interventions that improve patients' symptom burden and make a difference to everyday living. This study aims to assess the feasibility of conducting a definitive randomised controlled trial of a holistic, complex breathlessness intervention in people with IPF.Methods and analysisThe trial is a two-centre, randomised controlled feasibility trial of a complex breathlessness intervention compared with usual care in patients with IPF. 50 participants will be recruited from secondary care IPF clinics and randomised 1:1 to either start the intervention within 1 week of randomisation (fast-track group) or to receive usual care for 8 weeks before receiving the intervention (wait-list group). Participants will remain in the study for a total of 16 weeks. Outcome measures will be feasibility outcomes, including recruitment, retention, acceptability and fidelity of the intervention. Clinical outcomes will be measured to inform outcome selection and sample size calculation for a definitive trial.Ethics and disseminationYorkshire and The Humber – Bradford Leeds Research Ethics Committee approved the study protocol (REC 18/YH/0147). Results of the main trial and all secondary end-points will be submitted for publication in a peer-reviewed journal.

scholarly journals Preschool HABIT-ILE: study protocol for a randomised controlled trial to determine efficacy of intensive rehabilitation compared with usual care to improve motor skills of children, aged 2–5 years, with bilateral cerebral palsy

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e041542
Author(s):  
Leanne Sakzewski ◽  
Sarah Reedman ◽  
Kate McLeod ◽  
Megan Thorley ◽  
Andrea Burgess ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Usual Care ◽  
Motor Function ◽  
Motor Skills ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Gross Motor ◽  
Gross Motor Function ◽  
Randomised Controlled

IntroductionYoung children with bilateral cerebral palsy (BCP) often experience difficulties with gross motor function, manual ability and posture, impacting developing independence in daily life activities, participation and quality of life. Hand Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE) is a novel intensive motor intervention integrating upper and lower extremity training that has been developed and tested in older school-aged children with unilateral and BCP. This study aims to compare an adapted preschool version of HABIT-ILE to usual care in a randomised controlled trial.Methods and analysis60 children with BCP aged 2–5 years, Gross Motor Function Classification System (GMFCS) II–IV will be recruited. Children will be stratified by GMFCS and randomised using concealed allocation to either receive Preschool HABIT-ILE or usual care. Preschool HABIT-ILE will be delivered in groups of four to six children, for 3 hours/day for 10 days (total 30 hours). Children receiving Preschool HABIT-ILE be provided a written home programme with the aim of achieving an additional 10 hours of home practice (total dose 40 hours). Outcomes will be assessed at baseline, immediately following intervention and then retention of effects will be tested at 26 weeks. The primary outcome will be the Peabody Developmental Motors Scales–Second Edition to evaluate gross and fine motor skills. Secondary outcomes will be gross motor function (Gross Motor Function Measure-66), bimanual hand performance (Both Hands Assessment), self-care and mobility (Pediatric Evaluation of Disability Inventory-Computer Adapted Test), goal attainment (Canadian Occupational Performance Measure), global performance of daily activities (ACTIVLIM-CP), cognition and adaptive function (Behavior Rating Inventory of Executive Function—Preschool Version), habitual physical activity (ActiGraph GT3X+) and quality of life (Infant Toddler Quality of Life Questionnaire and Child Health Utility Index-9). Analyses will follow standard principles for RCTs using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/59444) and The University of Queensland (2020000336/HREC/19/QCHQ/59444).Trial registration numberACTRN126200000719.

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