Blood Pressure Changes During Moderate Intensity Strength Training in Aortic Stent-graft Patients
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Contact: Christian Have (christian.have.dall@regionh.dk)
Brief summary: Patients with an aortic stent graft are recommended to do muscle strengthening exercise as part of their rehabilitation. But, as excess blood pressure pose a risk to the integrity of the stent graft, high intensity muscle strengthening exercise may potentially be detrimental, and hence moderate intensity muscle strengthening is recommended. However, the blood pressure changes during moderate intensity strengthening exercises are unknown, and this study aims to quantify these among patients and compare them to those of healthy volunteers.
The purpose of this study is to investigate the increase in blood pressure during quadriceps muscle strength training in patients with aortic stent graft.
Time plan: 2018
Registration: https://clinicaltrials.gov/ct2/show/NCT03424863
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Liver cirrhosis |
SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy (SMILE)
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| Contact: Christian Have (christian.have.dall@regionh.dk) Brief summary: To investigate whether simple reminders about healthy lifestyle sent via mobile phone text messages can improve the liver cirrhosis severity and prognosis (as assessed by the MELD score supported by the Child-Pugh score) among patients with liver cirrhosis that have been through a 12-week supervised and facility-based physical exercise training program and in-patient rehabilitation. Time plan: 2016-2018 Registration: https://clinicaltrials.gov/ct2/show/NCT02811887 Publications: |
Osteoarthritis |
Digital Motivation to Decrease Inactive Behaviour in Patients With Knee Osteoarthritis
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Contact: Cecilie Bartholdy (cecilie.roedgaard.bartholdy@regionh.dk)
Brief summary: Physical inactivity is a major risk behaviour with a potential for causing premature death, particularly among people with mobility limitations, such as knee osteoarthritis.
Digital motivational interventions (such as SMS) can motive to a healthy behaviour including increased physical activity.
The purpose of this study is to investigate if motivational text messages following an exercise intervention to improve mobility limitations will change the physical activity level in patients with knee osteoarthritis.
This study is designed as pilot randomized controlled trial, with equal randomization (1:1). Eligible participants will be randomised into one of two groups (intervention or control) after completing their baseline measurements. The intervention group will receive weekly motivational text messages and the control group will not receive any attention from the study.
Time plan: 2016-2018
Registration: https://clinicaltrials.gov/ct2/show/NCT03339011
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Knee Replacement Outcome Predicted by Physiotherapists
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Contact: Marius Henriksen (Marius.henriksen@regionh.dk)
Brief summary: The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards can predict the future course (post hospitalisation) of recovery of patients undergoing KA. The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor prognosis; 10=best prognosis).
Time plan: 2016-2019
Registration: https://clinicaltrials.gov/ct2/show/NCT02982785
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Physical Activity in relation to current management of osteoarthritis (PhD-project)
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Contact: Cecilie Bartholdy (cecilie.roedgaard.bartholdy@regionh.dk)
Brief summary: Fysisk aktivitet måles vha af accelerometer før og efter vægttab, træning eller kirurgisk behandling af knæartrose.
Time plan: 2016-2018
Registration: https://clinicaltrials.gov/ct2/show/NCT03125954
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Weight
Loss and Physical Activity in Overweight/Obese Individuals With Knee
Osteoarthritis
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Contact: Cecilie Bartholdy (cecilie.roedgaard.bartholdy@regionh.dk)
Brief summary: This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis. In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.
This substudy aims to investigate any changes in physical activity associated with the initial 8-week weight loss intervention.
Time plan: 2016-2018
Registration: https://clinicaltrials.gov/ct2/show/NCT02910544
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Patellofemoral pain |
Comparison of Exercise Therapies for Patellofemoral Pain (COMPETE)
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Contact: Rudi Hansen (rudi.hansen@regionh.dk)
Brief summary: Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young adults. PFP is characterised by significant retropatellar and/or peripatellar pain and impairment of function and quality of daily life. Exercise therapy is unequivocally recommended as a core component of the management of PFP. Different exercise types (e.g. quadriceps strengthening, hip strengthening and functional/neuromuscular exercises) have been investigated, with knee and hip strengthening exercises as the most common and recommended types. These exercises approaches produce similar small to moderate effects on pain and physical function. However, the PFP population is very heterogeneous and "one-size-fits-all"-approaches presumably are sub-optimal because the heterogeneity is ignored. The heterogeneity probably explains the overall limited beneficial effects of exercise, and the lack of differences in direct comparisons of different exercise types. In that sense, it is not unlikely that certain patient characteristics may predict outcome success of either a hip training program or a training program that focus on the quadriceps but this remains to be shown. This study has two aims: 1. To assess the comparative effectiveness of two different exercise programs (Quadricep Exercise [QE] vs. Hip Exercise [HE]) on self-reported pain and function in individuals with PFP.
2. To explore candidate patient characteristics that predict differential responses to the two exercise programs (QE vs HE) on self-reported pain and physical function in individuals with PFP.
Time plan: 2017–2020
Registration: https://clinicaltrials.gov/ct2/show/NCT03069547
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Pulmonary rehabilitation |
Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? (REPLACE)
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Contact: Christian Have (christian.have.dall@regionh.dk)
Brief summary: The purpose is to evaluate if physical exercise intervention leads to an improved asthma control as measured by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can be reduces in asthmatics.
Time plan: 2017-2020
Registration: https://clinicaltrials.gov/ct2/show/NCT03290898
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Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease (TAPAS)
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Contact: Christian Have (christian.have.dall@regionh.dk) Brief summary: The aim of this study is to investigate if patients hospitalised for medical disease will increase their time spent out of bed during hospitalisation through simple feedback about physical activities from a mobile device. Time plan: 2017-2018 Registration: https://clinicaltrials.gov/ct2/show/NCT03333850 Publications: |
Shoulder |
Progressive
Active Exercise After Surgical Rotator Cuff Repair (CUT’n’MOVE)
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Contact: Birgitte Hougs Kjær (Birgitte.hougs.kjaer@regionh.dk)
Brief summary: The aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.
Time plan: 2016-2019
Registration: https://clinicaltrials.gov/ct2/show/NCT02969135
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Stroke rehabilitation |
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Electrical somatosensory stimulation in early rehabilitation of arm paresis after stroke: A randomized controlled trial
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Contact: Emma Ghaziani (emma.ghaziani@regionh.dk)
Brief summary: Arm paresis is present in 48–77% of acute stroke patients. Complete functional recovery is reported in only 12–34%. Although the arm recovery is most pronounced during the first 4 weeks post-stroke, few studies examined the effect of upper extremity interventions during this period. The objective of this study was to investigate the effect of electrical somatosensory stimulation (ESS) delivered during early stroke rehabilitation on the recovery of arm functioning. A number of 102 patients with arm paresis were randomized to a high-dose or a low-dose ESS-group within 7 days post-stroke according to our sample-size estimation. The high-dose group received 1-hour ESS to the paretic arm daily during hospitalization immediately followed by minimum 15-minute task-oriented arm training that was considered a component of the usual rehabilitation. The low-dose group received a placebo ESS followed by identical training. Primary outcome: Box and Block Test; secondary outcomes: Fugl-Meyer Assessment of Upper Extremity, grip strength, pinch strength, perceptual threshold of touch, pain and modified Rankin Scale; all recorded at baseline, post-intervention and at 6 months post-stroke.
Time plan: completed, 2014-2018
Registration: ClinicalTrials.gov: NCT02250365
Publications:
1. Ghaziani E, Couppe C, Henkel C, et al. Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial. Trials 2017; 18: 84. DOI: 10.1186/s13063-017-1815-9.
2. Ghaziani E, Couppé C, Siersma V, Søndergaard M, Christensen H, Magnusson SP. Electrical somatosensory stimulation in early rehabilitation of arm paresis after stroke: A randomized controlled trial. Neurorehabilitation & Neural Repair (in press) |
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Can clinical tests early post-stroke aid the prediction of arm functioning at 6 months?
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Contact: Emma Ghaziani (emma.ghaziani@regionh.dk)
Brief summary: To be applicable in clinical practice, prognosis of arm recovery after stroke needs to be based on easy-to-perform, meaningful measures. Several clinical tests have been proposed for prognosis of arm functioning; further validation of their predictive value is needed. The objective of this study was to examine the individual predictive value of easy-to-perform clinical tests for early prognosis of arm functioning. We performed a secondary analysis of merged data from two independent studies (n=223). Following variables measured 3−7 days post-stroke using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) were considered as potential predictors: shoulder abduction and elbow extension within synergies, forearm pronation/supination, wrist dorsiflexion, mass finger extension, grasping ability and the sensory subscale. Logistic regression was used for each predictor to calculate the odds ratio of two levels of arm functioning measured with the motor part of FMA-UE at 6 months post-stroke: FMA-UE-motor ≥32 and ≥58.
Time plan: 2018
Registration: ClinicalTrials.gov: NCT02250365, NCT01115348
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Tendinopathy |
Treatment of Patellar Tendinopathy
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