Physical Activity Clinical Trial
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.
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.
This will be an investigator-initiated, prospective pilot study which aims to recruit 30
patients in total and conducted over 24 months.
Study Aims and Hypotheses: Utilisation of healthcare resources and burden of care on society
for LTOT patients is disproportionately high. The study investigators aim to describe this
group of patients and introduce an intervention that aims to promote quality living with a
home-based physiotherapy programme.
1. To test the hypothesis that the intervention of a home-based physiotherapy programme
together with a lightweight POC will improve physical activity level, reduce daily time
spent in sedentary activity, improve Quality of Life (QoL) and reduce symptoms of
anxiety and depression of patients on LTOT
2. To describe the functional status of patients on LTOT and their caregivers - physical
activity levels, body mass index, psychological, socio-economic background, activities
of daily living (ADL) status
3. To describe the barriers to uptake of ambulatory oxygen in patients who fulfil criteria
for LTOT
4. As there is a lack of local data on the effectiveness and safety of a home-based
physiotherapy program, the study being conducted is a pilot study intended to establish
the feasibility of a home-based physiotherapy programme
STUDY BACKGROUND
1. Long-term oxygen therapy (LTOT) is an established medical intervention that has been
shown to prolong the survival of a select group of patients with respiratory failure (1,
2). Although local data on the incidence and prevalence of LTOT use in Singapore is
lacking, it has been reported in the Danish Oxygen Register that the annual incidence
and prevalence of LTOT use in 2010 was 32.2 and 48.1 per 100,000 inhabitants
respectively (3). Older studies have reported a LTOT prevalence of 28 per 100,000 in
1992 in the French Oxygen Register (4), LTOT incidence and prevalence of 7.1 and 24 per
100,000 respectively in 2000 in the Swedish Oxygen Register (5) and prevalence of LTOT
of 241 per 100,000 in the USA in 1994 (6). Chronic Obstructive Pulmonary Disease (COPD)
is by far the main respiratory diagnosis in LTOT patients followed by other diseases
such as interstitial lung disease and bronchiectasis (7). In addition, the medical
literature has documented rising LTOT usage over the years due to reasons such as
increasing survival of COPD patients and increased physician and patient awareness of
the benefits of LTOT (8). The costs of LTOT have been recognised to be high, with an
estimated 800,000 patients in USA utilising LTOT at cost of approximately $1.4 billion
American dollars annually according to a 1995 publication by O'Donohue et al (9). Total
Medicare payments for LTOT in 1998 were reported to be USD 1.3 billion (10). A more
recent analysis of 329,482 Medicare beneficiaries with COPD who received oxygen from
2001 to 2010 found that 73,659 (22.4%) received oxygen therapy (8).
2. The majority of patients utilise oxygen concentrators (OC) (3,11) which typically run on
continuous AC power and weigh between 13-22kg. This intervention, although
life-prolonging, nonetheless limits patient mobility as patients are required to utilise
oxygen therapy for at least 15 hours a day to benefit. As a result, many patients become
confined in their homes.
3. Indeed, patients with chronic respiratory disease requiring LTOT have been reported to
be severely limited in their physical activity. Studies of patients on LTOT have shown
that 46% of patients walk less than 600m per day (12) and up to 45% are house-bound
(13). While this may be due to low exercise tolerance, oxygen therapy may be a
contributory factor in itself as patients receiving oxygen from a stationary source
often become tethered their device over time. Although there are theoretical benefits to
improving exercise tolerance with oxygen therapy (14), it has been reported that
patients with severe COPD on LTOT have significantly reduced levels of domestic activity
compared with patients with COPD of similar severity but who were not on LTOT (15).
Patients with severe COPD and broadly similar health status on LTOT have also been
reported to be less independent on activities of daily living than those not requiring
LTOT (16).
4. Apart from reduced quality of life, reductions in daily activity levels have been shown
to be related to clinically relevant outcomes in COPD patients, such as reduced health
status (17), hospital admissions (18, 19) and survival (19) even after adjustment for
severity of COPD. Over the years, interest has shifted from improving exercise capacity
to increasing daily physical activity (20) which is defined as any bodily movement
produced by the contraction of skeletal muscles that increased energy expenditure (21).
In fact, it was found in a prospective cohort study of 170 outpatients with stable COPD
that objectively measured physical activity was the strongest predictor for all-cause
mortality in patients with COPD and that there was a linear association between physical
activity and mortality (22). Significant gains in quality of life and reduced
utilisation of healthcare stand to be made if the physical activity and mobility profile
of patients on LTOT can be increased.
5. An established intervention to improve the mobility and physical activity levels of LTOT
patients is Pulmonary Rehabilitation (PR). PR is a structured, multidimensional and
multidisciplinary programme over time (at least 6 weeks) that comprises physical
training and breathing exercises supervised by a respiratory physiotherapist in
conjunction with education guided by objective tests of the respiratory system and
exercise capacity such as pulmonary function tests, 6-minute walk test and
cardiopulmonary exercise testing. PR been shown to be cost-effective and beneficial in
improving shortness of breath, health status and exercise tolerance in patients of all
grades of COPD severity, including patients with chronic respiratory failure on LTOT
(23).
6. Although the benefits of PR are established, uptake and completion of PR is frequently
limited. The percentage of referred participants who did not attend PR at all ranged
from 8.3 to 49.6% in a systematic review (24). Many barriers have been cited, such as
low referral rates from healthcare providers (25) and low patient and healthcare
provider awareness of its availability and benefits. Usage of LTOT has also been found
to an independent predictor for non-attendance to PR (26). This is not surprising as
patients on LTOT face even greater difficulty than the average patient in participating
in PR due to challenges in being able to independently navigate the transportation
system to attend outpatient PR whilst on oxygen therapy. Another major barrier worth
mentioning is the lack of access from a combination of factors of geography, culture,
finances, transportation and other logistics (27, 28). This may be due to the fact that
PR is a healthcare-provider centric intervention that is traditionally conducted in a
healthcare institution in an outpatient or inpatient setting.
7. Locally in Singapore, patients face a financial disincentive towards participating in PR
in the outpatient setting as Medisave, the national medical savings scheme, imposes
limits on withdrawals for outpatient healthcare expenditure. Outpatient PR also imposes
hidden costs to the patient in the form of transportation and missed days at work for
family caregivers who accompany the patient for outpatient PR. Patients are often
accompanied by family caregivers or sponsors to healthcare visits in Singapore and the
lack of a caregiver to accompany patients for outpatient PR is an important cultural
barrier to PR. Inpatient PR in Singapore, on the other hand, is also limited in its
capacity to serve many patients due to the national strain on hospital beds. PR clearly
has its limitations as a modality in improving the poor physical activity levels of
patients on LTOT and a novel solution is needed that addresses the many barriers with PR
uptake.
8. The investigators are therefore proposing the establishment of a home-based
physiotherapy programme as a novel community and patient-centric and resource-lean
intervention that seeks to improve the physical activity 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 would include a home visit by a
physiotherapist. It is hypothesised that home-based physiotherapy would be more
patient-centric compared to healthcare centre-based physiotherapy as realistic
rehabilitation goal settings and exercise regimens can be personalised to each patient's
unique home and community environment, lifestyle and care needs. The proposed
intervention would be similar to an 8-week home-based PR study recently conducted in the
UK which comprised 1 home visit and 7 once-weekly telephone calls from a physiotherapist
in the home-based intervention arm which found equivalent short-term outcomes (such as
exercise tolerance and dyspnoea-related quality of life) that were equivalent to
outpatient centre-based PR (29).
9. Ambulatory Oxygen (AO) is an important enabler in improving the mobility of patients on
LTOT in the community and therefore their participation in PR. However there remain many
barriers to the uptake of AO such as (i) lack of instruction on the usage of AO, and
particularly with regards to AO delivered via oxygen cylinders, (ii) fear of running out
of their AO supply while they were using it, (iii) embarrassment and (iv) difficulties
with carrying the AO supply (30).
10. These barriers have led to low usage rates of AO via oxygen cylinder with only 39% of
patients using AO for more than 2 hours a week in a Danish study published in 1999 (31).
In the same study, it was reported that when patients had outdoor activity, the usage of
stationary oxygen fell by a couple of hours, resulting in lower overall oxygen usage.
This suggested that patients were spending a considerable time outside their home
without using their AO (31). In Italy where LTOT is almost exclusively provided by
liquid oxygen, it was reported that although most patients (84%) possessed an AO device,
only 40% declared that they used it daily with "being ashamed of being seen by passersby
with a stroller" being the principal barrier (7). Similar data was presented in a French
study which reported that most patients (630/930) used their oxygen only while resting
(32).
11. Compared to oxygen cylinders, AO delivered by lightweight Portable Oxygen Concentrator
(POC) has the advantages of being (i) user-friendly, (ii) aesthetically more pleasing
and is (iii) easily rechargeable with standard household electrical supply (33).
Such advantages will overcome some of the aforementioned barriers to AO usage.
12. A prospective pilot study of 30 patients is proposed. Assessment of activity levels, QoL
and breathlessness will be measured before and after 10 weeks. The 2 components of the
proposed intervention, namely the home-based physiotherapy programme and the
prescription of a lightweight POC are synergistic in its effects. Supplemental oxygen
has been shown to improve exercise duration (34) and therefore rehabilitation while it
has been shown that effective use of oxygen was improved by follow-up education, whether
given by nurse or physiotherapist, after initiation of oxygen therapy (32). It has been
shown that the prescription of AO alone does not automatically assure good adherence to
the prescribed treatment or use of AO outdoors (30). The guidance from the home-based
physiotherapy programme will comprise of a home visit by a physiotherapist with the aim
of reinforcing compliance and usage of AO outside the house, thereby improving the
patients' mobility over simply prescribing an AO device. It is hypothesised therefore
that patients will be encouraged to use their AO device when they are guided by a
home-based physiotherapy programme where rehabilitation goals and exercises are tailored
to each patient's unique "life-space" in the home and community.
13. In summary, the proposed intervention of a home-based activity education programme in
partnership with a community healthcare provider and in conjunction with a lightweight
POC may revolutionize the approach to patients with chronic respiratory failure in
Singapore and improve their ability to function independently in the community greatly;
in addition, the ability to stay active and community ambulant as well as the reduction
the demand on national healthcare resources (e.g. inpatient rehabilitation beds for PR)
is greatly advantageous.
Note - References have been cited in subsequent sections
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