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Trial record 2 of 4 for:    21273294 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03662438
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Singhealth Foundation
Information provided by (Responsible Party):
Singapore General Hospital

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.


Condition or disease Intervention/treatment Phase
Exercise Therapy Physical Activity Respiratory Failure Oxygen Inhalation Therapy Other: Home-based physiotherapy program Device: Prescription of a Portable Oxygen Concentrator (POC) device Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : September 9, 2018
Estimated Primary Completion Date : March 20, 2020
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Study Participants

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
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).

Device: Prescription of a Portable Oxygen Concentrator (POC) 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.




Primary Outcome Measures :
  1. Change in daily physical activity, which will be measured via the daily step count. [ Time Frame: Baseline, 10 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in respiratory disease specific quality of life questionnaire (St George's Respiratory Questionnaire (SGRQ)) [ Time Frame: Baseline, 10 weeks ]
    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.

  2. Change in The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 10 weeks ]
    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.

  3. Change in Exercise capacity as measured by 6 minute walk test [ Time Frame: Baseline, 10 weeks ]
    Participants will undergo exercise capacity assessment with the 6-minute walk test .

  4. Change in Exercise capacity assessment with 1 minute Sit to Stand test [ Time Frame: Baseline, 10 weeks ]
    Participants will undergo exercise capacity assessment with the 1-minute Sit to Stand test.

  5. Change in Participants' daily sedentary time [ Time Frame: Baseline, 10 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662438


Contacts
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Contact: Thun How Ong, Dr +65 63213985 ong.thun.how@singhealth.com.sg
Contact: Mariko SY Koh, A/Prof +65 65767862 mariko.koh.s.y@singhealth.com.sg

Locations
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Singapore
Department of Respiratory and Critical Care Medicine, Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Si Yuan Chew, MBBS    6563214700    siyuan.chew@mohh.com.sg   
Contact: Thun How Ong, MBBS    6563214700    ong.thun.how@singhealth.com.sg   
Sponsors and Collaborators
Singapore General Hospital
Singhealth Foundation
Investigators
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Principal Investigator: Thun How Ong, Dr Department of Respiratory and Critical Care Medicine, Singapore General Hospital

Publications:

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03662438     History of Changes
Other Study ID Numbers: HOPE Study
SHF/HSRHO013/2017 ( Other Grant/Funding Number: Singhealth Foundation )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Exercise
Physical Activity
Respiratory Failure
Oxygen Inhalation Therapy
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes