HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)

NCT03662438 | Unknown

• 2 other identifiers: HOPE StudySHF/HSRHO013/2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exercise Therapy; Physical Activity; Respiratory Failure; Oxygen Inhalation Therapy

Keywords

Exercise; Physical Activity; Respiratory Failure; Oxygen Inhalation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in respiratory disease specific quality of life questionnaire (St George's Respiratory Questionnaire (SGRQ))

  Baseline, 10 weeks

• Change in The Hospital Anxiety and Depression Scale (HADS)

  Baseline, 10 weeks

• Change in Exercise capacity as measured by 6 minute walk test

  Baseline, 10 weeks

• Change in Exercise capacity assessment with 1 minute Sit to Stand test

  Baseline, 10 weeks

• Change in Participants' daily sedentary time

  Baseline, 10 weeks

Study Arms (1)

Study Participants

OTHER

This is a self-controlled study where participants will serve as their own controls. All participants will be enrolled into a 10 week home-based physiotherapy program which will include a total of 2 home visits by a physiotherapist at the start and midpoint of the program. Participants will also receive weekly telephone calls by a research coordinator to provide encouragement for patient on the programme and enquire about compliance to the home exercise regimen and safety (e.g. falls and healthcare utilisation). Patients will also be prescribed a lightweight portable oxygen concentrator to facilitate exercise therapy and mobility in the community. They will receive familiarisation and training in its usage as part of the home-based physiotherapy program.

Other: Home-based physiotherapy program; Device: Prescription of a Portable Oxygen Concentrator (POC) device

Interventions

Home-based physiotherapy program OTHER

The home-based physiotherapy program will consist of a total of 2 home visits by a physiotherapist which will be scheduled at the start and midpoint of the 10-week program. The visit will include activity education, goal setting and establishment of a home exercise regimen in patient's own home and community environment). Participants will be contacted weekly via telephone to provide encouragement for patient on the program, enquire about compliance to the exercise program and safety (e.g. falls and healthcare utilisation).

Study Participants

Prescription of a Portable Oxygen Concentrator (POC) device DEVICE

Participants will be prescribed a lightweight Portable Oxygen Concentrator (POC) device \[Philips SimplyGo Mini\] to be used during exercise and when going into the community setting. Familiarisation and training on the usage of the device will also be provided in conjunction with the home-based physiotherapy program.

Study Participants

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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%).
• 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.
• Patients who are sufficiently mobile to perform a 6-minute walk test.

You may not qualify if:

• 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.
• 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.
• Patients who are actively smoking.
• Patients who are currently participating in a pulmonary rehabilitation programme.
• Patients who are pregnant.
• Patients who are unable or unwilling to complete questionnaires (e.g. patients on LTOT and home mechanical ventilation).

Sponsors & Collaborators

• Singapore General Hospital: lead
• Singhealth Foundation: collaborator

Study Sites (1)

Department of Respiratory and Critical Care Medicine, Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

Related Publications (28)

• 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. doi: 10.7326/0003-4819-93-3-391.

  PMID: 6776858 BACKGROUND

• 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.

  PMID: 6110912 BACKGROUND

• 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.

  PMID: 24275146 BACKGROUND

• 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. doi: 10.1378/chest.109.3.741.

  PMID: 8617085 BACKGROUND

• Gustafson T, Lofdahl K, Strom 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.

  PMID: 18980837 BACKGROUND

• 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. doi: 10.1016/j.rmed.2005.09.018. Epub 2005 Oct 20.

  PMID: 16242926 BACKGROUND

• 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.

  PMID: 25785586 BACKGROUND

• 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. doi: 10.1378/chest.107.2.301. No abstract available.

  PMID: 7842750 BACKGROUND

• 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. doi: 10.1136/thx.48.7.708.

  PMID: 8153918 BACKGROUND

• 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. doi: 10.1164/rccm.200507-1161WS. Epub 2006 Apr 13.

  PMID: 16614349 BACKGROUND

• 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. doi: 10.1097/00008483-200505000-00011.

  PMID: 15931024 BACKGROUND

• 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. doi: 10.1183/09031936.97.10071572.

  PMID: 9230249 BACKGROUND

• Esteban C, Quintana JM, Aburto M, Moraza J, Egurrola M, Perez-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.

  PMID: 20075059 BACKGROUND

• 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. doi: 10.1378/chest.129.3.536.

  PMID: 16537849 BACKGROUND

• Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto 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. doi: 10.1136/thx.2006.060145. Epub 2006 May 31.

  PMID: 16738033 BACKGROUND

• 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. No abstract available.

  PMID: 21813522 BACKGROUND

• Waschki B, Kirsten A, Holz O, Muller 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.

  PMID: 21273294 BACKGROUND

• 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. doi: 10.1016/j.rmed.2007.07.016. Epub 2007 Aug 28.

  PMID: 17728121 BACKGROUND

• 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.

  PMID: 21596892 BACKGROUND

• 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.

  PMID: 23945168 BACKGROUND

• 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.

  PMID: 23261311 BACKGROUND

• 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.

  PMID: 24489465 BACKGROUND

• 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.

  PMID: 27672116 BACKGROUND

• 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.

  PMID: 21314932 BACKGROUND

• Ringbaek T, Lange P, Viskum K. Compliance with LTOT and consumption of mobile oxygen. Respir Med. 1999 May;93(5):333-7. doi: 10.1016/s0954-6111(99)90314-1.

  PMID: 10464899 BACKGROUND

• Pepin 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 a Domicile des Insuffisants Respiratories. Chest. 1996 May;109(5):1144-50. doi: 10.1378/chest.109.5.1144.

  PMID: 8625658 BACKGROUND

• Dunne PJ. The clinical impact of new long-term oxygen therapy technology. Respir Care. 2009 Aug;54(8):1100-11.

  PMID: 19650950 BACKGROUND

• 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. doi: 10.1155/2010/142031.

  PMID: 20186361 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Respiratory Insufficiency

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Behavior; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Thun How Ong, Dr

  Department of Respiratory and Critical Care Medicine, Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thun How Ong, Dr

CONTACT

+65 63213985; ong.thun.how@singhealth.com.sg

Mariko SY Koh, A/Prof

CONTACT

+65 65767862; mariko.koh.s.y@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a self-controlled study where participants will serve as their own controls. Physical activity levels and quality of life will be measured before and after a 10 week home-based exercise program.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 7, 2018
• Study Start: September 9, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)