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,
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* 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 |
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