Exercise therapy and cognitive behavioural therapy to improve fatigue, daily activity performance and quality of life in Postpoliomyelitis Syndrome: the protocol of the FACTS-2-PPS trial

Contains fulltext : 88661.pdf (publisher's version ) (Open Access)BACKGROUND: Postpoliomyelitis Syndrome (PPS) is a complex of late onset neuromuscular symptoms with new or increased muscle weakness and muscle fatigability as key symptoms. Main clinical complaints are severe fatigue, deterioration in functional abilities and health related quality of life. Rehabilitation management is the mainstay of treatment. Two different therapeutic interventions may be prescribed (1) exercise therapy or (2) cognitive behavioural therapy (CBT). However, the evidence on the effectiveness of both interventions is limited. The primary aim of the FACTS-2-PPS trial is to study the efficacy of exercise therapy and CBT for reducing fatigue and improving activities and quality of life in patients with PPS. Additionally, the working mechanisms, patients' and therapists' expectations of and experiences with both interventions and cost-effectiveness will be evaluated. METHODS/DESIGN: A multi-centre, single-blinded, randomized controlled trial will be conducted. A sample of 81 severely fatigued patients with PPS will be recruited from 3 different university hospitals and their affiliate rehabilitation centres. Patients will be randomized to one of three groups i.e. (1) exercise therapy + usual care, (2) CBT + usual care, (3) usual care. At baseline, immediately post-intervention and at 3- and 6-months follow-up, fatigue, activities, quality of life and secondary outcomes will be assessed. Costs will be based on a cost questionnaire, and statistical analyses on GEE (generalized estimated equations). Analysis will also consider mechanisms of change during therapy. A responsive evaluation will be conducted to monitor the implementation process and to investigate the perspectives of patients and therapists on both interventions. DISCUSSION: A major strength of the FACTS-2-PPS study is the use of a mixed methods design in which a responsive and economic evaluation runs parallel to the trial. The results of this study will generate new evidence for the rehabilitation treatment of persons with PPS. TRIAL REGISTRATION: Dutch Trial Register NTR1371

The relationship between ambulatory step activity, self-reported physical functioning and standardised timed walking in patients with haematological malignancies

Purpose. This cross-sectional study investigated the degree of association between the results of ambulatory step activity monitoring (SAM), self-reported physical functioning (SRPF) and the 6-minute standardised walking test (6-MWT) in cancer patients with haematological malignancies. Method. Assessments of ambulatory SAM, SRPF and 6-MWT were assessed in 102 patients up to 122 days (mean 78+35) after haematopoietic stem cell transplantation (HSCT). To determine the association between measures of walking, the Pearson product moment correlation coefficient (r) including the 95%CI and the r2 were calculated. Simple linear regression analyses were performed to estimate the ambulatory step activity from SRPF and the 6-MWT. Results. The average age was 47 years (+12) and body mass index 23.4 (+4). The correlations were low between ambulatory SAM outputs and SRPF (ranging from70.32 to 0.34, p50.01), and very low between SAM outputs and 6-MWT, (ranging from 0.21 to 0.24). The correlation between SRPF and the 6-MWT was low (0.33, p50.01). The correlation between SRPF and the 6-MWT was low (0.33, p50.01). The 95%CIs were quite narrow around r. The shared variance (r2) between the SAM and SPPF ranged between 4% and 11% and the shared variance between the SAM and 6-MWT ranged between 0.5% and 18%. Linear regression yielded weak relationships and large standard errors of estimate between the SAM, SRPF and 6-MWT. Conclusions. SRPF and the 6-MWT do not reflect daily walking activity. In clinical use (e.g. to evaluate the effects of a rehabilitation program), ambulatory step activity outputs can be considered an additional outcome to assess day-to-day walking activity in patients with haematological cancer after HSCT

A candidate core set of outcome measures based on the international classification of functioning, disability and health for clinical studies on lower limb orthoses

Background: Although many core sets of measurement concepts have been published in the literature, this has not been done for the field of lower limb orthoses. Objectives: This paper provides an overview of the measurement concepts that are relevant in lower limb orthotic evaluations, and it proposes a candidate Core Set of outcome measures to be used in clinical studies on ankle-foot orthoses (AFOs) and knee-ankle-foot orthoses (KAFOs). Study Design: Literature review. Methods: The International Classification of Functioning, Disability and Health (ICF) was used as framework to select relevant concepts. Results and conclusion: Measurement concepts covering all ICF levels of functioning were identified as relevant for the Core Set, including functions of the joints and bones (b710-b729), muscle functions (b730-b749), gait pattern functions (b770), walking (b450), moving around in different locations (d460), and daily-life functioning (d5-d9). Further validation of this candidate Core Set through a formal decision-making process is needed to obtain consensus among experts in the field. Based on such a consensus, the next step will be to systematically review the literature and identify those measurement instruments that are best suited to assess the proposed concepts, based on their psychometric properties in a given sample and context. Thereafter, we suggest that this ICF Core Set of measurement instruments should be applied in orthotic studies on AFOs and KAFOs in ambulatory patients with gait problems. Clinical relevance Although many ICF Core Sets have been published, this has not been done for the field of lower limb orthoses. We feel that such a Core Set is urgently needed, to enable comparison of results, and establish evidence on the efficacy of orthotic treatment, which will improve patient care. © The International Society for Prosthetics and Orthotics 2011

European consensus on the concepts and measurement of the pathophysiological neuromuscular responses to passive muscle stretch

BACKGROUND AND PURPOSE: To support clinical decision-making in central neurological disorders, a physical examination is used to assess responses to passive muscle stretch. However, what exactly is being assessed is expressed and interpreted in different ways. A clear diagnostic framework is lacking. Therefore, the aim was to arrive at unambiguous terminology about the concepts and measurement around pathophysiological neuromuscular response to passive muscle stretch. METHODS: During two consensus meetings, 37 experts from 12 European countries filled online questionnaires based on a Delphi approach, followed by plenary discussion after rounds. Consensus was reached for agreement ≥75%. RESULTS: The term hyper-resistance should be used to describe the phenomenon of impaired neuromuscular response during passive stretch, instead of for example 'spasticity' or 'hypertonia'. From there, it is essential to distinguish non-neural (tissue-related) from neural (central nervous system related) contributions to hyper-resistance. Tissue contributions are elasticity, viscosity and muscle shortening. Neural contributions are velocity dependent stretch hyperreflexia and non-velocity dependent involuntary background activation. The term 'spasticity' should only be used next to stretch hyperreflexia, and 'stiffness' next to passive tissue contributions. When joint angle, moment and electromyography are recorded, components of hyper-resistance within the framework can be quantitatively assessed. CONCLUSIONS: A conceptual framework of pathophysiological responses to passive muscle stretch is defined. This framework can be used in clinical assessment of hyper-resistance and will improve communication between clinicians. Components within the framework are defined by objective parameters from instrumented assessment. These parameters need experimental validation in order to develop treatment algorithms based on the aetiology of the clinical phenomena.status: publishe

The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in polio survivors: protocol for a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Many Polio survivors have reduced mobility, pain and fatigue, which make access to conventional forms of aerobic exercise difficult. Inactivity leads to increased risk of health problems, many of which are prevalent among Polio survivors. Aerobic exercise programmes in Polio survivors should utilise stable muscle groups and should be designed to minimise exacerbation of pain and fatigue. A home-based arm ergometry aerobic exercise programme may represent an affordable and accessible exercise modality, incorporating exercise prescription principles in this group.</p> <p>Methods/design</p> <p>This is a prospective, single blinded, randomised controlled trial. There are two arms; exercise intervention using arm ergometers and control. Polio survivors meeting eligibility criteria will be recruited and randomly allocated to intervention or control groups. Participants allocated to the intervention group will receive a small arm ergometer and a polar heart rate monitor. They will carry out a home-based moderate intensity (50-70% HRMax) aerobic exercise programme for eight weeks, following instruction by the treating physiotherapist. Assessments will occur at baseline and after eight weeks and will include tests of physical fitness, activity, energy cost of walking, fatigue and quality of life. Clinically feasible assessment tools including the Six Minute Arm Test, the Physical Activity Scale for People with Physical Disabilities questionnaire, the Physiological Cost Index, Fatigue Severity Scale and the SF-36v2 will be utilised.</p> <p>Discussion</p> <p>The efficacy of a home-based arm ergometry programme in Polio survivors will be examined. No previous trial has examined such a programme using a wide range of outcome measures pertinent to Polio survivors. This study will provide new information on the impact of arm ergometry on physical fitness, activity, body composition, fatigue, pain, muscle strength, and health related quality of life. Also, the study will provide information, which at present is lacking, on safety of aerobic exercise in Polio, as potential negative outcomes of activity including loss of muscle strength, increased pain and fatigue will be closely monitored.</p> <p>Trial registration</p> <p>Clinicaltrials.gov identifier: NCT01271530</p

Analyzing subcomponents of affective dysregulation in borderline personality disorder in comparison to other clinical groups using multiple e-diary datasets

Background: Affective dysregulation is widely regarded as being the core problem in patients with borderline personality disorder (BPD). Moreover, BPD is the disorder mainly associated with affective dysregulation. However, the empirical confirmation of the specificity of affective dysregulation for BPD is still pending. We used a validated approach from basic affective science that allows for simultaneously analyzing three interdependent components of affective dysregulation that are disturbed in patients with BPD: homebase, variability, and attractor strength (return to baseline). Methods: We applied two types of multilevel models on two e-diary datasets to investigate group differences regarding three subcomponents between BPD patients (n =43; n =51) and patients with posttraumatic stress disorder (PTSD; n= 28) and those with bulimia nervosa (BN; n= 20) as clinical control groups in dataset 1, and patients with panic disorder (PD; n= 26) and those with major depression (MD; n =25) as clinical control groups in dataset 2. In addition, healthy controls (n= 28; n= 40) were included in the analyses. In both studies, e-diaries were used to repeatedly collect data about affective experiences during participants’ daily lives. In study 1 a high-frequency sampling strategy with assessments in 15 min-intervals over 24 h was applied, whereas the assessments occurred every waking hour over 48 h in study 2. The local ethics committees approved both studies, and all participants provided written informed consent. Results: In contradiction to our hypotheses, BPD patients did not consistently show altered affective dysregulation compared to the clinical patient groups. The only differences in affective dynamics in BPD patients emerged with regard to one of three subcomponents, affective homebase. However, these results were not even consistent. Conversely, comparing the patients to healthy controls revealed a pattern of more negative affective homebases, higher levels of affective variability, and (partially) reduced returns to baseline in the patient groups. Conclusions: Our results indicate that affective dysregulation constitutes a transdiagnostic mechanism that manifests in similar ways in several different mental disorders. We point out promising prospects that might help to elucidate the common and distinctive mechanisms that underlie several different disorders and that should be addressed in future studies

Studies examining the efficacy of ankle foot orthoses should report activity level and mechanical evidence

Ankle Foot Orthoses (AFOs) to promote walking ability are a common treatment in patients with neurological or muscular diseases. However, guidelines on the prescription of AFOs are currently based on a low level of evidence regarding their efficacy. Recent studies aiming to demonstrate the efficacy of wearing an AFO in respect to walking ability are not always conclusive. In this paper it is argued to recognize two levels of evidence related to the ICF levels. Activity level evidence expresses the gain in walking ability for the patient, while mechanical evidence expresses the correct functioning of the AFO. Used in combination for the purpose of evaluating the efficacy of orthotic treatment, a conjunct improvement at both levels reinforces the treatment algorithm that is used. Conversely, conflicting outcomes will challenge current treatment algorithms and the supposed working mechanism of the AFO. A treatment algorithm must use relevant information as an input, derived from measurements with a high precision. Its result will be a specific AFO that matches the patient's needs, specified by the mechanical characterization of the AFO footwear combination. It is concluded that research on the efficacy of AFOs should use parameters from two levels of evidence, to prove the efficacy of a treatment algorithm, i.e., how to prescribe a well-matched AFO. © 2010 ISPO