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 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 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 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.

scholarly journals “VelaMente?!” - Sailin in a Crew to Improve Self-Efficacy in People with Psychosocial Disabilities: A Randomized Controlled Trial

2017 ◽  
Vol 13 (1) ◽  
pp. 200-212 ◽  
Author(s):  
Federica Sancassiani ◽  
Alessio Cocco ◽  
Giulia Cossu ◽  
Stefano Lorrai ◽  
Giuseppina Trincas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Sense Of Coherence ◽  
Self Efficacy ◽  
Longitudinal Research ◽  
Short Form ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Waiting List ◽  
Treatment As Usual

Introduction:It has been proposed that sailing can improve quality of life, personal and social skills of people with severe psychosocial disabilities. This study aimed to assess the efficacy of a psychosocial rehabilitative intervention focused on sailing on quality of life, self-efficacy and sense of coherence in people with severe psychosocial disabilities.Methods:The study was a randomized, with parallel groups, waiting-list controlled trial. Participants were 51 people with severe psychosocial disabilities. The intervention was a structured course to learn sailing in a crew lasting three months. A randomized group began the sailing course immediately after a pre-treatment assessment; the waitlist group began the sailing course after a three months period of treatments as usual. Participants were assessed before and after the sailing course, or the waiting list period, on the General Self-Efficacy scale (GSES), Sense Of Coherence scale (SOC) and Health Survey-short form (SF-12).Results:Self-efficacy significantly increased after the sailing course and decreased after treatment as usual (p=0.015). Sense of coherence and the levels of quality of life tended to improve after the sailing course, albeit below levels of statistical significance.Conclusion:When compared to more traditional psychosocial rehabilitative activities, an intervention focused on sailing in a crew positively impacts the sense of coherence and the levels of quality of life and significantly improves self-efficacy of people with severe psychosocial disabilities. Further longitudinal research is required.

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 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.

The Effect of Educational Program on Pain Management, Self-Efficacy Behavior, and Quality of Life among Adult Diabetic Patients with Peripheral Neuropathy Pain: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Jawad Ahmad Abu-Shennar ◽  
Nurhan Bayraktar
Keyword(s):  
Quality Of Life ◽  
Pain Management ◽  
Educational Intervention ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group ◽  
Diabetic Care

Abstract Objective Jordan has a high prevalence of painful diabetic peripheral neuropathy (PDPN), leg complications, and amputations due to diabetes. This study evaluated the effect of educational programs on pain management, self-efficacy behaviors, and quality of life (QoL) among adult patients with PDPN. Methods The randomized controlled trial study was conducted at the Jordanian Ministry of Health hospitals between October 2019 – March 2020. Seventy-two adult patients with PDPN were randomized to an experimental group of 36 patients who attended an educational program and a control group who followed routine diabetic care in the study setting. The data were collected using a socio-demographic and diabetes clinical/laboratory data form, the numeric rating scale (NRS), diabetes self-efficacy scale (DSES), and the quality-of-life questionnaire (EQ-5D). The intervention program consisted of four educational sessions at weekly intervals. Pre-test and post-test evaluations were conducted. Results After the educational intervention, the mean scores of the NRS (p=0.020), DSES (p<0.001), and EQ-5D (p<0.001) in the experimental group improved significantly improved compared to those in the control group. Additionally, while there were no significant correlations between the three study outcomes in the pre-test stage, correlations were observed to be significant after the educational intervention. Conclusion This study shows that the design and implementation of educational intervention combined with routine diabetic care facilitate effective pain management, self-efficacy behaviors, and QoL of patients with PDPN. The health care providers are recommended to use the educational programs for such patients at various levels of services in both health centers and diabetes clinics.

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