Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03737890 |
| Other study ID # |
U/SERC/92/2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2, 2018 |
| Est. completion date |
February 13, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
Universiti Tunku Abdul Rahman |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Frailty is a clinical syndrome that alters the structure and function of respiratory system
which causes stiffness of thoracic cage and reduces the chest wall compliance in addition of
respiratory muscle weakness that can lead to the reduction of pulmonary function. The aim of
this study was to compare the effect of inspiratory muscle training (IMT) and hold-relax
pectoral stretch on pulmonary function (FVC, FEV1 and FEV1/FVC) among frail elderly
Description:
Aging leads to the biological and physiological changes in the human body but it is more
pronounced in frail elderly. One of the body systems which will undergo changes due to aging
is the respiratory system. Respiratory system changes can be in terms of mechanics, muscular
and immunological aspects. These changes often lead to respiratory impairment or more often
defined as spirometrically airflow limitation or restrictive- pattern. Aging will change the
structure of thoracic cage, causing a reduction in chest wall compliance. Moreover, aging
disease such as osteoporosis also causes stiffening of the thoracic cage and kyphosis. As a
result, the ribcage is unable to expand and contract, causing difficulty in breathing. In
addition, atrophy of skeletal muscles leads to increased loss of lean tissue. With the loss
of lean tissue in the respiratory muscles, the pulmonary function of an elderly will
subsequently be compromised. All these changes decrease the volume of the thoracic cavity and
reduce lung volumes which leads to limitation of air flow, decrease of FEV1, FVC and FEV1/FVC
as well as increase in residual volume and functional residual capacity. As a result, elderly
will tend to have increased work of breathing compared to younger individuals.
Other than that, immunological changes that occur in the elderly increases their risk of
getting respiratory tract infection, leading to development of pulmonary disease such as
pneumonia. In addition, elderly have higher exposure to second-hand smoke, toxin exposure
from the environment which can predispose them to chronic obstructive pulmonary disease
leading to dyspnea and alter the pulmonary function. All these changes can have a strong
impact on morbidity, mortality and quality of life in elderly.
As a person ages, observable changes can be seen in body composition and body phenotype.
These changes will alter the structure and function of the respiratory system. Prevention and
intervention programs are necessary to minimize the loss of respiratory function in order to
reverse the progression of frailty condition. Exercises such as inspiratory muscle training
(IMT) and hold relax pectoral stretch has been found to be helpful in strengthening the
breathing muscles and improving pulmonary function respectively. Studies have shown that
these two exercises will help in increasing the pulmonary function but till date there is no
study which has been carried out to find the effectiveness of these 2 exercises on pulmonary
function in frail elderly.
A total of 34 residents from Seavoy Nursing Home were recruited after screening (excluded;
bed ridden participants, not able to communicate and give their consent, suffering from a
ruptured eardrum or any other condition of the ear, abnormally low perception of dyspnea,
presence of cardiac pacemaker, unable to do overhead movement and hyper-mobility of
shoulder). Based on the inclusion criteria, the participants needed to be above 60 years of
age, currently residing in a care facility, a citizen of Malaysia, ability to understand
Malay, English, Mandarin and Cantonese and able to score more than 16 out of 30 in Montreal
Cognitive assessment (MoCA). Score of 16 and above on MoCA was to make sure participants were
able to follow and understand the instructions given during testing and intervention. This
was followed by assessment for frail criteria. At least 3 of the frail criteria; shrinking,
weakness, poor endurance, slowness of gait, and low physical activity level needed to be met
by participants. Questions such as body weight, height, losing weight, their daily physical
activity, their endurance and power status by self reported exhaustion were asked. For
shrinking, body weight and height were measured and compared to nursing homes past 1 year
record. Participants with unintentional weight loss of 4.5Kgs or more from past 1 year were
considered for this study. Weakness criterion was evaluated by checking the grip strength of
the dominant hand with cut-off point for different BMI. Besides that, the poor endurance
criterion was assessed using two statements of the CES-D scale: "I felt that everything I did
was an effort" and "I could not get going" for much or most of the time, when asked. A low
physical activity criterion was met if male scored less than 64 and female less than 52 on
Physical Activity Scale for the Elderly (PASE). Besides the slow gait speed criterion was met
if the participant took more than 10 seconds to walk back and forth over a ten-foot.
After meeting all the inclusion criteria, participants were randomly divided into either into
experimental group who did inspiratory muscle training or control group who did hold-relax
pectoral stretch. Pulmonary function (FVC, FEV1, FEV1/FVC) were measured by spirometer in
sitting upright position. A nose clip was used and participants were instructed to tightly
securing the lips around the mouth piece of spirometer. A single trail was run to make sure
participants know how to use the spiromter before actual test was conducted.
For screening purpose, Montreal Cognitive assessment (MoCA) was used to evaluate the
cognitive status. Physical Activity Scale for the Elderly (PASE) was used to evaluate the
physical activity level of the elderly. Center for Epidemiologic Studies Depression Scale
(CES- D) was used to evaluate the poor endurance and energy of the elderly. Dynamometer
(Jamar hydraulic hand dynamometer) was used to measure the grip strength of the elderly to
evaluate the weakness. Furthermore, Portable spirometer (MIR Spirobank II ®) was used to
measure the outcome measures (FVC, FEV1, FEV1/FVC). Last but not least, IMT device
(Respironics Threshold IMT) was used for inspiratory muscle training.
34 participants were assigned into two groups; control group and experimental group. Each
participant was supposed to complete a total of 12 sessions of exercises, 3 sessions per week
for 4 weeks. In control group, the participants received 3 sets of passive hold- relax
pectoral stretch for each session. Each stretch was maintained for 10 seconds with a rest
period of 30 seconds given between the sets. Participants were in sitting position, shoulders
held in abducted position with elbows flexed and both hand joined behind the neck. The
subjects were asked to contract the agonist muscles and hold for 10 seconds while resistance
was applied to the contraction.
On the other hand, participants in the experimental group were given Inspiratory Muscle
Training by using an IMT device (Respironics Threshold IMT). Participants were in Fowler's
position. Based on the protocol of Inspiratory Muscle Training, a nose clip was used during
the training. Participants were advised to inform the researchers and stop the exercise
immediately if they felt dizziness or breathlessness. Before the training, participants were
taught how to use the device and were instructed to use the correct breathing technique while
using the device. For this training, the inspiratory load for each participant was set at 30
cmH2O. During the protocol, researchers observed the participants for their facial expression
to ensure that they do not breath forcefully to exhaust themselves. Verbal cue such as don't
lift up the chest when doing the breathing exercise, use diaphragm to perform the exercise
were given. Participants performed three sets of ten breaths with resting period of one
minute between the sets.
The primary outcome measure in this study was pulmonary function. The measures of pulmonary
function were: Forced vital capacity (FVC), forced expiratory volume in one second (FEV1),
FEV1/FVC. These were assessed by spirometry and expressed in litres. The measures were
assessed with the participants in sitting position with the use of nose clip. A clear
instruction was given to the participants to expire forcefully out into the disposable
mouthpiece and after the machine provide a sound, the participants were asked to inspire
forcefully from the disposable mouthpiece. A trail run was performed before running the
actual test. The measurement of FVC, FEV1 and FEV1/FVC was evaluated before and after the
intervention. Data was recorded in the data collection sheet. However, during this study
there were 2 dropouts from experimental group who refused to continue the exercise after
first week of intervention. There were also 2 dropouts from the control group as 1
participant was discharged from the nursing home in the second week of the study and another
one felt sick in the last week of intervention. Hence, data analysis was performed only for
15 participants in each group.
