Physical Activity Clinical Trial
— HOPEOfficial title:
HOPE (Home-based Oxygen [Portable] and Exercise) - Improving Mobility in Patients on Long Term Oxygen Therapy: a Home-based Physiotherapy Programme With Novel Ambulatory Oxygen Device.
Long term oxygen therapy (LTOT) is proven to increase the survival of patients with
respiratory failure, most commonly from diseases such as Chronic Obstructive Pulmonary
Disease (COPD). At least 15 hours' usage per day is needed to improve mortality. Most
patients on LTOT utilise bulky oxygen concentrators (OC) which run on continuous Alternating
Current (AC) power. This intervention, however, limits patient mobility and social engagement
as patients are tethered to their device and confined to their homes.
Reduced physical activity levels have been shown in COPD patients to be associated with
reduced quality of life (QoL), increased admission rates to hospital and survival even after
adjustment for severity of COPD. Significant benefits stand to be made by improving physical
activity levels in LTOT patients. Pulmonary Rehabilitation (PR), which is traditionally
conducted in a healthcare setting, is an established intervention that addresses this by
improving exercise tolerance but uptake and completion rates have been low due to reasons
such as cost and difficulty with transport. LTOT usage is also cited as an independent
barrier to PR.
The investigators propose the establishment of a 10-week home-based physiotherapy programme
as a novel community-centric and resource-lean intervention that seeks to improve the
physical activity level of LTOT patients. Patients will be prescribed an ambulatory oxygen
device and receive education on its usage in conjunction with a home exercise regimen which
includes a home visit and subsequent telephone support by a physiotherapist in partnership
with a community-based healthcare provider.
A prospective pilot study of 30 patients is proposed. The outcome measures include mobility
function, activity levels, generic and disease-specific QoL.
If successful, our programme may revolutionize the approach to LTOT patients in Singapore and
improve their ability to function independently in the community greatly; in addition, the
reduction in hospital-based healthcare utilisation is greatly advantageous.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 20, 2020 |
Est. primary completion date | March 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility |
Inclusion Criteria (participants are required to fulfill all of the following criteria): 1. Patients aged 21-90 years old who are able to provide informed consent and have their consent signed and dated. Subjects must be able to complete questionnaires. 2. Patients who meet criteria for LTOT i.e. PaO2 =55mmHg on room air or PaO2 =59mmHg (with pulmonary hypertension, RV hypertrophy, Cor pulmonale, haematocrit =55%). 3. Patients should be on LTOT on =3 months (to avoid the inclusion of patients who were prescribed oxygen following acute illness). 4. Patients should have clinical stability of their underlying chronic cardiac (e.g. pulmonary hypertension) or respiratory diseases (e.g. COPD, ILD), as demonstrated by no recent acute exacerbation of respiratory/cardiac illness, acute healthcare utilisation (presentation to GP, polyclinic or hospital) or change in medication (or adjustments of non-invasive ventilation) for =6 weeks before enrolment. 5. Patients who are sufficiently mobile to perform a 6-minute walk test. Exclusion Criteria: 1. Patients with any life-threatening condition with a low probability (in the opinion of the investigator) of survival for at least 3 months or who has been hospitalised more than 3 times in the preceding 1 year for respiratory failure. 2. Patients who are not able to ambulate with the lightweight POC (they must be able to perform a 6-minute walk test - this can be unaided or with walking aid) or who have significant limitation of ambulation due to non-respiratory causes such as musculoskeletal (e.g. osteoarthritis) or neuromuscular disease (e.g. Parkinson's disease or stroke), or who are assessed to have no rehabilitation potential. 3. Patients who are actively smoking. 4. Patients who are currently participating in a pulmonary rehabilitation programme. 5. Patients who are pregnant. 6. Patients who are unable or unwilling to complete questionnaires (e.g. patients on LTOT and home mechanical ventilation). |
Country | Name | City | State |
---|---|---|---|
Singapore | Department of Respiratory and Critical Care Medicine, Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital | Singhealth Foundation |
Singapore,
Arnold E, Bruton A, Donovan-Hall M, Fenwick A, Dibb B, Walker E. Ambulatory oxygen: why do COPD patients not use their portable systems as prescribed? A qualitative study. BMC Pulm Med. 2011 Feb 11;11:9. doi: 10.1186/1471-2466-11-9. — View Citation
Carone M, Patessio A, Ambrosino N, Baiardi P, Balbi B, Balzano G, Cuomo V, Donner CF, Fracchia C, Nava S, Neri M, Pozzi E, Vitacca M, Spanevello A. Efficacy of pulmonary rehabilitation in chronic respiratory failure (CRF) due to chronic obstructive pulmonary disease (COPD): The Maugeri Study. Respir Med. 2007 Dec;101(12):2447-53. Epub 2007 Aug 28. — View Citation
Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9. — View Citation
Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. — View Citation
Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006 Aug 15;174(4):373-8. Epub 2006 Apr 13. — View Citation
Dunne PJ. The clinical impact of new long-term oxygen therapy technology. Respir Care. 2009 Aug;54(8):1100-11. Erratum in: Respir Care. 2009 Oct;54(10):1413. — View Citation
Esteban C, Quintana JM, Aburto M, Moraza J, Egurrola M, Pérez-Izquierdo J, Aizpiri S, Aguirre U, Capelastegui A. Impact of changes in physical activity on health-related quality of life among patients with COPD. Eur Respir J. 2010 Aug;36(2):292-300. doi: 10.1183/09031936.00021409. Epub 2010 Jan 14. — View Citation
Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Antó JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. Epub 2006 May 31. — View Citation
Gustafson T, Löfdahl K, Ström K. A model of quality assessment in patients on long-term oxygen therapy. Respir Med. 2009 Feb;103(2):209-15. doi: 10.1016/j.rmed.2008.09.018. Epub 2008 Nov 5. — View Citation
Hayton C, Clark A, Olive S, Browne P, Galey P, Knights E, Staunton L, Jones A, Coombes E, Wilson AM. Barriers to pulmonary rehabilitation: characteristics that predict patient attendance and adherence. Respir Med. 2013 Mar;107(3):401-7. doi: 10.1016/j.rmed.2012.11.016. Epub 2012 Dec 19. — View Citation
Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, McDonald CF. Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax. 2017 Jan;72(1):57-65. doi: 10.1136/thoraxjnl-2016-208514. Epub 2016 Sep 26. — View Citation
Jones SE, Green SA, Clark AL, Dickson MJ, Nolan AM, Moloney C, Kon SS, Kamal F, Godden J, Howe C, Bell D, Fleming S, Haselden BM, Man WD. Pulmonary rehabilitation following hospitalisation for acute exacerbation of COPD: referrals, uptake and adherence. Thorax. 2014 Feb;69(2):181-2. doi: 10.1136/thoraxjnl-2013-204227. Epub 2013 Aug 14. — View Citation
Keating A, Lee A, Holland AE. What prevents people with chronic obstructive pulmonary disease from attending pulmonary rehabilitation? A systematic review. Chron Respir Dis. 2011;8(2):89-99. doi: 10.1177/1479972310393756. Review. — View Citation
Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6. — View Citation
Neri M, Melani AS, Miorelli AM, Zanchetta D, Bertocco E, Cinti C, Canessa PA, Sestini P; Educational Study Group of the Italian Association of Hospital Pulmonologists (AIPO). Long-term oxygen therapy in chronic respiratory failure: a Multicenter Italian Study on Oxygen Therapy Adherence (MISOTA). Respir Med. 2006 May;100(5):795-806. Epub 2005 Oct 20. — View Citation
Nishi SP, Zhang W, Kuo YF, Sharma G. Oxygen therapy use in older adults with chronic obstructive pulmonary disease. PLoS One. 2015 Mar 18;10(3):e0120684. doi: 10.1371/journal.pone.0120684. eCollection 2015. — View Citation
O'Donohue WJ Jr, Plummer AL. Magnitude of usage and cost of home oxygen therapy in the United States. Chest. 1995 Feb;107(2):301-2. — View Citation
Okubadejo AA, O'Shea L, Jones PW, Wedzicha JA. Home assessment of activities of daily living in patients with severe chronic obstructive pulmonary disease on long-term oxygen therapy. Eur Respir J. 1997 Jul;10(7):1572-5. — View Citation
Pépin JL, Barjhoux CE, Deschaux C, Brambilla C. Long-term oxygen therapy at home. Compliance with medical prescription and effective use of therapy. ANTADIR Working Group on Oxygen Therapy. Association Nationale de Traitement à Domicile des Insuffisants Respiratories. Chest. 1996 May;109(5):1144-50. — View Citation
Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Physical activity and hospitalization for exacerbation of COPD. Chest. 2006 Mar;129(3):536-44. — View Citation
Restrick LJ, Paul EA, Braid GM, Cullinan P, Moore-Gillon J, Wedzicha JA. Assessment and follow up of patients prescribed long term oxygen treatment. Thorax. 1993 Jul;48(7):708-13. — View Citation
Ringbaek T, Lange P, Viskum K. Compliance with LTOT and consumption of mobile oxygen. Respir Med. 1999 May;93(5):333-7. — View Citation
Ringbaek TJ, Lange P. Trends in long-term oxygen therapy for COPD in Denmark from 2001 to 2010. Respir Med. 2014 Mar;108(3):511-6. doi: 10.1016/j.rmed.2013.10.025. Epub 2013 Nov 14. — View Citation
Sandland CJ, Singh SJ, Curcio A, Jones PM, Morgan MD. A profile of daily activity in chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2005 May-Jun;25(3):181-3. — View Citation
Thorpe O, Kumar S, Johnston K. Barriers to and enablers of physical activity in patients with COPD following a hospital admission: a qualitative study. Int J Chron Obstruct Pulmon Dis. 2014 Jan 21;9:115-28. doi: 10.2147/COPD.S54457. eCollection 2014. — View Citation
Voduc N, Tessier C, Sabri E, Fergusson D, Lavallee L, Aaron SD. Effects of oxygen on exercise duration in chronic obstructive pulmonary disease patients before and after pulmonary rehabilitation. Can Respir J. 2010 Jan-Feb;17(1):e14-9. — View Citation
Waschki B, Kirsten A, Holz O, Müller KC, Meyer T, Watz H, Magnussen H. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest. 2011 Aug;140(2):331-342. doi: 10.1378/chest.10-2521. Epub 2011 Jan 27. — View Citation
Wouters EFM, Franssen FME, Spruit MA. Survival and physical activity in COPD: a giant leap forward! Chest. 2011 Aug;140(2):279-281. doi: 10.1378/chest.11-0521. — View Citation
* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in daily physical activity, which will be measured via the daily step count. | Daily physical activity will be measured via the daily step count. This will be measured with the activPAL device, a validated tool to measure physical activity. Participants will have the activPAL device applied to their mid-thigh continuously with an adhesive patch for 1 week prior to the home physiotherapy program and for the 10th week of the home physiotherapy program. | Baseline, 10 weeks | |
Secondary | Change in respiratory disease specific quality of life questionnaire (St George's Respiratory Questionnaire (SGRQ)) | Participants will complete the respiratory disease specific quality of life questionnaire St George's Respiratory Questionnaire (SGRQ) at enrollment and after the 10 week home physiotherapy program. | Baseline, 10 weeks | |
Secondary | Change in The Hospital Anxiety and Depression Scale (HADS) | Participants will complete the Hospital Anxiety and Depression Scale (HADS) questionnaire at enrollment and after the 10 week home physiotherapy program to measure the levels of anxiety and depression. | Baseline, 10 weeks | |
Secondary | Change in Exercise capacity as measured by 6 minute walk test | Participants will undergo exercise capacity assessment with the 6-minute walk test . | Baseline, 10 weeks | |
Secondary | Change in Exercise capacity assessment with 1 minute Sit to Stand test | Participants will undergo exercise capacity assessment with the 1-minute Sit to Stand test. | Baseline, 10 weeks | |
Secondary | Change in Participants' daily sedentary time | Daily sedentary time will be measured via the time spent in sedentary body postures (e.g. supine and sitting) as opposed to time spent in active body postures (walking and standing). This will be measured with the activPAL device. Participants will have the activPAL device applied to their mid-thigh continuously for 1 week with an adhesive patch. | Baseline, 10 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
Active, not recruiting |
NCT03903874 -
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
|
N/A | |
Withdrawn |
NCT04540523 -
Home-Based Exergaming Intervention
|
N/A | |
Recruiting |
NCT03250000 -
Changes in Microcirculation and Functional Status During Exacerbation of COPD
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Completed |
NCT05019482 -
Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time
|
N/A | |
Completed |
NCT03253406 -
Health Wearables and College Student Health
|
N/A | |
Not yet recruiting |
NCT05985460 -
A Very Brief Intervention to Increase the Intention to Practice Physical Activity
|
N/A | |
Completed |
NCT03380143 -
Whole-of-Community Youth Population Physical Activity
|
N/A | |
Completed |
NCT03700736 -
The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups
|
N/A | |
Completed |
NCT03170921 -
Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals
|
N/A | |
Completed |
NCT04973813 -
Active Choice Intervention About Physical Activity for Physically Inactive Adults
|
N/A | |
Completed |
NCT03982095 -
Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
|
||
Completed |
NCT03271112 -
Frailty Prevention in Elders From Reunion Island
|
N/A | |
Completed |
NCT05670223 -
Healthy Activities Improve Lives
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Recruiting |
NCT04578067 -
Empowering Immigrant Women for Active and Healthy Lifestyle
|
N/A | |
Completed |
NCT03297567 -
Physical Therapy Guidelines For Hospitalized Elderly
|
N/A | |
Completed |
NCT02869854 -
Increased Physical Activity Through Mindfulness
|
N/A |