AIIHPC Final Report – Clinical Research Fellowship
Authors:
David Hegarty: Research Fellow – St Francis Hospice
Dr Regina McQuillan: Lead Supervisor – St Francis Hospice
Lisa McGirr: Clinical support – St Francis Hospice
Fiona Cahill: Clinical Support – St Francis Hospice
Dr Rose Galvin: Academic Support – Royal College of Surgeons in Ireland
Title:
Physiotherapy led Palliative Exercise Programme for Parkinson’s Disease (PEP-PD) Patients in an Out-Patient Setting: a feasibility study
Background
Parkinson’s disease (PD) is a progressive neurological disorder with the number of individuals affected in Europe estimated as 1.2 million in 2005 and this is expected to double by 20301. The main clinical manifestations of PD are bradykinesia, tremor, postural instability and rigidity 2. PD is usually classified using the Hoehn and Yahr (H&Y) scale of 1-5, with one being the least symptomatic and five being the most symptomatic. In recent years research has demonstrated that there is a role for specialist palliative care services for PD patients3, 4. The need for palliative care has been identified between H&Y stage 3-5 or after approximately 12 years since PD diagnosis3, 5.
A cross sectional survey of 82 people with PD (PwP) by Saleem et al (2013) found that 80% of palliative stage PD patients 3-5 H&Y reported difficulty with their mobility6. Mobility issues are one the most frequently reporteddebilitating symptoms in this patient cohort, in the context of gait rehabilitation, research has shown that strength based exercise interventions can positively affect gait parameters in PwP7-9. However, studies to date have focused suchinterventions on populations with stages 1-3 H&Y.
Aim
The aim of the study is to examine the feasibility of a lower limb strength-based progressive exercise programme for people with PDH&Y Stage 3 or 4 in a hospice setting.
Design
A small scale feasibility study was conducted with a single patient cohort and pre-test, post-test design using mixed methods in the form of quantitative outcome measures and qualitative semi-structured interviews.
Study setting and participants
Ethical approval was received from the Research Ethics Committee at St. Francis Hospice, Dublin. The study took place in a hospice out-patient physiotherapy department.Referrals were accepted from the Neurology and Physiotherapy departments of specialist hospitalsand from community physiotherapists.
Participants were included if they were over 18 years of age, H&Y Stage 3 or 4, able to walk 10 meters with or without an aid and in the referring clinician’s opinion, cognitively able to take part in a rehabilitation programme.
Participants were excluded if they had engaged in regular exercise over the last six months. For the purposes of this study, regular exercise was defined as30 minutes of formal exercise (gym, swimming, exercise class) three times per week any time over the past six months.
The Physical Activity Readiness Questionnaire10 (PAR-Q)was completed during the screening process and the patient’s general practitioner or consultant neurologist was contacted to discuss the patient’s suitability to engage with the exercise programme if the patient answered ‘no’ to one or more of the questions on the PAR-Q.
DemographicsAge (yrs) / 69.86 (SD - 7)
Sex / 13m/1f
TSD (yrs) / 14.14 (SD – 16)
H&Y 3 (n) / 7
H&Y 4 (n) / 7
Medication changes (n) / 1
Written informed consent was obtained from all participants. Participants completed a baseline assessment, with a blinded assessor (FC),using outcome measures of impairment, activity limitation and participation restrictions.The following outcome measures were used: Six Minute Walk Test (SMWT)11, Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)12 and Parkinson’s Disease Questionaire-39 (PDQ-39)13. Participants’ lower limb strength was also assessed for their predicted one repetition maximum (p1-RM) using the Wathen equation from McNair et al (2011) p1-RM multiplication factors.14 The p1-RM was used to establish the training weight of participants for their exercise programme.
Patients’training weight was between 40-70% of the p1-RM10.The aim of selection was to ensure weight ranges were adhered to by reducing the number of times weights had to be adjusted to minimise patient burden.Weights were increased in 13 of the participants at either the third or fourth week based on the clinical judgement of the physiotherapist training the exercise class (DH). Weights were adjusted based on the clinical judgement of the physiotherapist training the exercise class.
The PEP-PD programme consisted of one session per week for six weeks and was completed at the hospice, the exercise program is further explained in Appendix 1. Participants completed two sessions per week for six weeks at home. Adherence was measured by a weekly phone call or upon discussion with patients during their weekly attendance.
Patients attended for a follow up appointment within 2 weeks of completing the programme where post-test outcome measures and p1-RM were repeated by the blinded assessor. They were also invited to take part in semi-structured interviewsfacilitated by an external researcher trained in qualitative interviewing, this will be reported elsewhere.
The results of the quantitative outcome measures were assessed as described below. Distribution of data was assessed using the Shapiro-Wilk W test for normal data. Paired t-test was used to assess parametric results and Wilcoxon signed-rank test was used for all non-parametric results. Bonferroni methods were used to adjust for multiple comparisons.
Results:
Nineteen referrals were received from the recruitment sites (Table 1).Fourteen participants took part in the programme with twelve patients completing the pre and post outcome measure assessments. Participants were aged between 57 and 85 yearswith a mean age of 69.8 years. Time since diagnosis varied from three months to over forty four years with a mean of just over one year and two months. The stage of disease was evenly split between seven participants at stage three and seven at stage four H&Y. The flow of participants through the study is displayed in Figure 1.
There was a significant improvement in all measures of strength of the lower limb following the intervention (p<0.05). There was no significant difference in changes in walking capacity as measured by the SMWT [mean change 26.9 metres, 95% CI -8.6 - 62.4), p=0.12]. Similar non-significant changes were reported for the PDQ-39 and the MDS-UPDRS. Descriptive statistics are provided in more detail in Table 2a and 2b below.
Table 2a displays a summary of the baseline physical measures of participants who took part in the programme
Predicted 1-Rep Max (Kg) / N / Mean / SD / Min / MaxKnee Extension Right / 14 / 10.52 / 3.69 / 2.93 / 16.87
Knee Extension Left / 14 / 9.5 / 3.49 / 2.73 / 15
Hip Flexion Right / 14 / 9.62 / 3.50 / 5.12 / 16.9
Hip Flexion Left / 14 / 8.94 / 3.3 / 3.28 / 14.63
Hip Extension Right* / 14 / 8.56 / 3.51 / 4.68 / 14.13
Hip Extension Left / 14 / 7.82 / 3.88 / 2.83 / 14.63
Hip Abduction Right / 14 / 10.47 / 4.37 / 4.68 / 16.88
Hip Abduction Left* / 14 / 9.40 / 4.06 / 4.8 / 16
Knee Flexion Right / 14 / 7.96 / 3.20 / 3 / 12.8
Knee Flexion Left / 14 / 7.60 / 2.95 / 3.13 / 12.8
Six minute walk test (meters) / 14 / 305.71 / 138.41 / 30 / 520
MDS-UPDRS
Part 1 / 14 / 15.57 / 5.87 / 8 / 28
Part 2 / 14 / 20.93 / 6.86 / 12 / 35
Part 3 / 14 / 49.07 / 12.11 / 33 / 80
Part 4 / 14 / 3.86 / 2.93 / 0 / 7
Total / 14 / 89.57 / 23.64 / 60 / 150
PDQ-39
Mobility / 13 / 54.03 / 33.1 / 0 / 100
Activities of Daily Living* / 12 / 46.18 / 22.23 / 20.83 / 100
Emotional well being / 13 / 38.46 / 23.02 / 12.5 / 83.33
Stigma / 13 / 28.4 / 27.2 / 0 / 87.5
Social support / 12 / 11.78 / 16.85 / 0 / 50
Cognitions / 13 / 42.3 / 18.62 / 12.5 / 68.75
Communication / 12 / 33.34 / 27.98 / 0 / 91.67
Bodily discomfort / 12 / 49.28 / 29.79 / 0 / 100
Total / 12 / 37.75 / 14.7 / 19.32 / 71.3
*denotes non-parametric distribution of results
Table 2b displays a summary of the post-intervention physical measures of participants who took part in the programme
Knee Extension Right / 12 / 14.19 / 5.85 / 4.2 / 23.63
Knee Extension Left / 12 / 13.87 / 5.35 / 3.93 / 22.93
Hip Flexion Right / 12 / 15.95 / 7.23 / 6.4 / 26.66
Hip Flexion Left / 12 / 15.47 / 6.29 / 6.75 / 28.17
Hip Extension Right / 12 / 15.15 / 6.93 / 5.65 / 26.66
Hip Extension Left / 12 / 15.15 / 7.11 / 5.45 / 29.03
Hip Abduction Right / 12 / 16.58 / 7.29 / 6.55 / 27.9
Hip Abduction Left / 12 / 16.63 / 8.15 / 6 / 31.73
Knee Flexion Right / 12 / 15 / 5.75 / 6.55 / 23.7
Knee Flexion Left / 12 / 14.46 / 6.24 / 5.65 / 24.96
Six minute walk test (meters) / 13 / 327.30 / 134.04 / 50 / 510
MDS-UPDRS
Part 1 / 13 / 16.46 / 6.39 / 8 / 29
Part 2 / 13 / 20.08 / 8.27 / 7 / 36
Part 3 / 13 / 48.46 / 8.59 / 35 / 69
Part 4 / 13 / 2.69 / 2.1 / 0 / 6
Total / 13 / 87.69 / 20.18 / 63 / 138
PDQ-39
Mobility / 12 / 53.54 / 31.49 / 5 / 92.5
Activities of Daily Living / 12 / 47.57 / 18.42 / 12.5 / 75
Emotional well being / 11 / 39.90 / 18.53 / 16.17 / 66.67
Stigma / 12 / 25.51 / 21.73 / 0 / 56.25
Social support / 12 / 15.97 / 15.68 / 0 / 50
Cognitions* / 12 / 42.19 / 15.35 / 25 / 75
Communication / 12 / 40.26 / 31.75 / 0 / 83.3
Bodily discomfort / 12 / 60.40 / 15.54 / 33.3 / 83.33
Total / 11 / 39.53 / 12.92 / 20.67 / 68.83
*denotes non-parametric distribution of results
Qualitative Research
All participants were invited to take part in semi-structured interviews, two were unable due to scheduling, and twelve participants were facilitated by an external researcher trained in qualitative interviewing. The qualitative results are currently being analysed using grounded theory to extract thematic results.
These interviews have been transcribed verbatim and preliminary coding has been completed. The initial analysis has shown a clear theme of ‘improved self-efficacy’. A full review was not possible within the time scale of the current clinical research fellowship.
The results of this analysis will be sent to the AIIHPC upon completion of the ongoing analysis with a provisional completion date of March 2015.
Conclusions:
The results suggest a six week progressive intensity strength training programme improves lower limb strength in people with advanced PD. The feasibility of the programme is also evident from the low levels of attrition from the programme.
The findings of the study need to be interpreted in the context of the study limitations. The lack of a comparison group reduces the internal validity of this study. To this end, further research should address the following issues:
Study Design – a pragmatic exploratory randomised controlled trial is needed to improve the internal and external validity of the findings.
Population – Consideration should be given to co-morbidities including acute medical or surgical problems as strenuous exercise may exacerbate these health problems.
Intervention – The intervention should be expanded to include upper limb and core-strengthening exercises.
Outcomes –A measure of falls was lacking in the current study. It is recommended that a falls diary and questionnaire on perceived exercise self-efficacy such as the Physical Activity Scale for the Elderly (PASE) should be included.15
Overall this study has highlighted the potential benefits of engaging in regular high-intensity exercise for people with palliative PD. Further research should consider optimising the generalizability of these findings through the implementation of a pragmatic randomised controlled trial.
Implications for Practice
The results suggest a six week progressive intensity strength training programme improves lower limb strength in people with advanced PD. However, the findings of the study need to be interpreted in the context of the study limitations.
Plans for Dissemination/Outputs from project
Ethics:
In keeping with the ethical approval of this project all participants, who requested results, will be sent a letter outlining the anonymised results of this study.
Publication:
The attached short report will be submitted to an academic journal (Palliative Medicine) for publication and wider research exposure.
A second qualitative paper will be completed in the coming months and submitted for publication to an academic journal
Presentation:
An abstract submission has been made for Oral/Poster presentation to the IAPC Annual Education and Research Seminar 2015 and will be made for the World Parkinson’s Congress 2016.
The research fellow has been invited to present the results at the Irish Hospice Foundation and Neurological Alliance of Ireland round table meeting titled ‘The palliative care needs of people with advancing neurological conditions in Ireland’ on the 3rd of November.
Local staff:
In-service presentations have been offered to all staff in St Francis Hospice with the first presentation completed on the 30th of October.
What were the key challenges you encountered during your time as a clinical fellow?
The key challenges I experienced were the management, timekeeping and data collection requirements of a research project and the logistics that this type of research requires.
What were your key aspects of learning?
I have learnt how to run and manage a mixed methods study and service development. The key aspects of learning I have experienced are the pragmatic nature of clinical research and the importance of flexibility as a result. This has been invaluable as a skill development at the beginning of my research career.
How did the grant you received specifically assist you to undertake the project? (ie how did you use the money)
Time was the key component of the support from the funding. Through the funding of another physiotherapist to manage a part of my clinical caseload I was able to dedicate my time and energy to completing this research fellowship. The availability of transport for patients was also an invaluable resource that has made this research possible. Transcription of semi-structured interviews was a crucial component in beginning the initial coding and analysis that is currently ongoing. I attend a two day course in London titled ‘Physiotherapy in Palliative Care’ and a two day workshop on grounded theory in Trinity College Dublin with the funding from the AIIHPC.
Would you recommend this grant opportunity to others and do you consider this is worthwhile scheme? (Please explain)
Yes. I feel this is an excellent stepping stone for young researchers as it allows for dedicated time and support to engage in clinical research while maintaining a clinical caseload and permanent job.
References
1.Onarheim K-J, Lindvall S, Graham L. The European Parkinson's disease standards of care consensus statement [abstract]. Movement Disorders 2014;29(Suppl 1):450.2.KNGF. Parkinson’s Disease. In: KNGF, editor. Amersfoort: Royal Dutch Society for Physical Therapy; 2006.
3.Higginson IJ, Gao W, Saleem TZ, Chaudhuri KR, Burman R, McCrone P et al. Symptoms and quality of life in late stage Parkinson syndromes: a longitudinal community study of predictive factors. PloS one 2012;7(11):e46327.
4.Waldron M, Kernohan WG, Hasson F, Foster S, Cochrane B, Payne C. Allied health professional’s views on palliative care for people with advanced Parkinson’s disease. International Journal of Therapy and Rehabilitation, 2011;18(1):11.
5.Parkinson's Disease: National clinical guideline for diagnosis and management in primary and secondary care. London: Royal College of Physicians of London; 2006.
6.Saleem TZ, Higginson IJ, Chaudhuri KR, Martin A, Burman R, Leigh PN. Symptom prevalence, severity and palliative care needs assessment using the Palliative Outcome Scale: a cross-sectional study of patients with Parkinson's disease and related neurological conditions. Palliat Med 2013;27(8):722-31.
7.Lima LO, Scianni A, Rodrigues-de-Paula F. Progressive resistance exercise improves strength and physical performance in people with mild to moderate Parkinson's disease: a systematic review. J Physiother 2013;59(1):7-13.
8.Crizzle AM, Newhouse IJ. Is physical exercise beneficial for persons with Parkinson's disease? Clinical Journal of Sport Medicine 2006;16(5):422-5.
9.Mehrholz J, Friis R, Kugler J, Twork S, Storch A, Pohl M. Treadmill training for patients with Parkinson's disease. Cochrane database of systematic reviews (Online) 2010(1):CD007830.
10.Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM et al. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc 2011;43(7):1334-59.
11.Lord SR, Menz HB. Physiologic, psychologic, and health predictors of 6-minute walk performance in older people. Arch Phys Med Rehabil 2002;83(7):907-11.
12.Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P et al. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord 2008;23(15):2129-70.
13.Marinus J, Ramaker C, van Hilten JJ, Stiggelbout AM. Health related quality of life in Parkinson's disease: a systematic review of disease specific instruments. J Neurol Neurosurg Psychiatry 2002;72(2):241-8.
14.McNair PJ, Colvin M, Reid D. Predicting maximal strength of quadriceps from submaximal performance in individuals with knee joint osteoarthritis. Arthritis Care Res (Hoboken) 2011;63(2):216-22.
15.Ellis T, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Fredman L et al. Factors associated with exercise behavior in people with Parkinson disease. Phys Ther 2011;91(12):1838-48.
Appendices
Appendix 1 – Exercise Program
Each exercise was completed in three sets of eight repetitions for each class with a three second hold during each repetition at the end of range. The exercises were performed with parallel bars for hand support and chairs with arm rests for breaks between sets.
5 exercises
Knee extension – in sitting
Knee flexion – in standing
Hip abduction – in standing
Hip flexion – in standing
Hip extension – in standing
FITT
The below is a description of the FITT details of the program from PEP-PD
Frequency – Three times weekly (Once supervised in the hospice and twice at home)
Intensity – 40-70% of the predicted one repetition max
Time – 40-60 minutes in the class setting
Type – Ankle weights from between 2-12.5 kilograms
PEP-PD Budget
Activity / Associated cost / Co-/matched funding (if applicable) / Actual CostFunding physiotherapist to cover 7 hours per week protected time for the 12 month duration on the program / €6700 / €6,700
Equipment (Theraband ,weights, etc) / €0 / €300 funded by St Francis Hospice. / €600
Stationery & admin support / €0 / €500 funded by St Francis Hospice. / €500
Courses (as outlined in Q19 below) / €500 / €895 funded by HSE / €1395
Patient Transport contingency / €500 / €500
Refreshments / €0 / €150 funded by St Francis Hospice.
Use of facilities/utilities / €0 / St Francis Hospice
Transcription / €1000 / €500 (Funded by St Francis Hospice)
Total: / €8700 / €1845
A €1000 underspend was achieved through receptionists at St Francis Hospice undertaking the transcription costs which was funded by St Francis Hospice. The excess €1000 could be used to aid dissemination and the current six month follow-up that is underway. The transport costs for the six month follow up are budgeted at €300. Dissemination of the results through the funding of attendance at the IAPC Annual Education and Research Seminar and at the World Parkinson’s Congress 2016 in Portland, USA. IAPC cost of two attendees €120 and flight to World Parkinson’s Congress is €800-900 (Registration, accommodation and cost excess to be covered by the research fellow)
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