Plain English Summary
Background and study aims
Pulmonary (lung) capacity deteriorates gradually with age. However, regular physical exercise can improve lung function even in elderly people, improving their ability to perform daily activities such as walking. We want to study how a program of weekly physical exercise on a treadmill can improve lung function, compared with the standard recommendations on healthy lifestyle and regular exercise.
Who can participate?
Healthy volunteers aged between 60 and 70
What does the study involve?
Participants undergo a 48-week physical exercise program consisting of walking on a treadmill three times a week. Another similar group of participants is encouraged to walk twice a week and receives the standard recommendations for good health.
What are the possible benefits and risks of participating?
The expected benefits are improved lung function compared with people following the standard recommendations. Possible risks are limited to falling from the treadmill.
Where is the study run from?
Dar El Salam General Hospital (Egypt)
When is the study starting and how long is it expected to run for?
March 2006 to September 2013
Who is funding the study?
1. University of Córdoba (Spain)
2. Dar El Salam General Hospital (Egypt)
Who is the main contact?
Dr José Luis Lancho
cm1laalj@uco.es
Study website
Contact information
Type
Scientific
Contact name
Dr José Luis Lancho
ORCID ID
Contact details
Avenida de Menéndez Pidal s/n
Córdoba
14071
Spain
+34 (0)957 218 256
cm1laalj@uco.es
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1/2007
Study information
Scientific title
Efficacy of treadmill exercises on arterial blood oxygenation, oxygen consumption and walking distance in healthy elderly people: a non-randomized controlled trial
Acronym
HETWAP
Study hypothesis
Treadmill walking is better than standard recommendations on health for healthy elderly people.
Ethics approval(s)
1. Ethics Committee of Dar El Salam General Hospital in Cairo, 15/01/2007, Number 1/2007
2. Ethics Committee of the Department of Morphological Sciences, School of Medicine, University of Córdoba, 09/10/2008, Number 29102008
Study design
Prospective single-centre non-randomized single-blinded controlled intervention trial
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Aerobic power
Intervention
Participants were incorporated in an exercise program of moderate intensity (walking on the treadmill) 3 times weekly for 48 weeks; the first 12 weeks were supervised and the remaining 36 weeks of the program were unsupervised. The duration of complete training sessions was of 30 minutes the first three weeks, 40 minutes the next two weeks, 50 minutes the next two weeks, and 60 minutes until the end of the program.
The intervention exercise protocol was applied based on the protocol of Naughton. The exercise program consisted of walking on a treadmill with fixed 0% grade of inclination. The exercise program consists of 3 phases:
1. Warming up phase of 5 minutes on the treadmill
2. Active phase in which the speed of the treadmill is increased to achieve at least 60% and not more than 70% of the maximum heart rate (HR max) according to the protocol of Fletcher and collaborators. The treadmill inclination is fixed at 0% grade during the whole program, so the intensity of the exercise could be increased or decreased only by changing the speed of the treadmill. The active phase of exercise is 20 minutes for the first 3 weeks, 30 minutes for the next two weeks, 40 minutes for the followings two weeks and finally for 50 minutes until the end of the program
3. Cooling down phase for a period of 5 minutes which is achieved by reducing the speed gradually till reaching zero and until the heart rate returned almost to resting level.
A treadmill DKN Run Tech 2.5 with adjustable speed, inclination and timer, and a large LCD screen with 23 training programs and 3 users’ profiles was used. The screen displays simultaneously walking time and distance, speed, inclination, burned calories and heart rate. The treadmill has front and/or side rails to aid in subject stability. Also, a Pulsometer (HR) p610 Accurex Plus was utilized for monitoring of heart rate.
Participants in the control group were encouraged to walk twice a week during 45 minutes through enlightening the benefits of moderate physical activity on health, and received standard recommendations for proper health. A telephone follow-up of the adherence to recommended exercise guidelines was conducted weekly.
Intervention type
Behavioural
Primary outcome measure
1. Measurement of Oxygen saturation (SaO2). Pulse Oximeter CMS 50DL Finger Pulse Oximeter SaO2 was used to measure SaO2. It was measured one week prior training; pulse oximeter was utilized to measure SaO2 in the right index of each individual. Each individual had to rest for two minutes before the beginning of the measurement. After placing the sensor on the finger, we waited until a reading was displayed on the oximeter, then we waited for another 10-15 seconds to verify a steady signal, this is followed by recording SaO2 and pulse every 10 seconds. Six observations were recorded and their average was used as the individual’s SaO2 as in previous studies. These measurements were taken in a specific cardiopulmonary test, regardless of the training sessions.
2. Measurement of Maximum Oxygen consumption (VO2max). A Cardiopulmonary Exercise Test unit (CPET) Zan 800, a gas analyser of O2 and CO2 was used for the measurement of VO2max. Before conducting the test, the humidity collector was cleaned, the connected tube was checked, and the triple V- valve sensor disinfected and the gas analyser calibrated. The heart rate and blood pressure were recorded in the relaxed sitting position for each subject of the group. The mask was fixed with straps and then the triple tube V was connected to the mask. Initially, metabolic parameters such as oxygen consumption, carbon dioxide production and heart rate at rest were measured every three minutes. These measurements were taken in a specific cardiopulmonary test, regardless of the training sessions.
3. Maximal Walking Distance (MWD). This data was obtained from the treadmill DKN Run Tech 2.5. MWD is displayed on the screen. MWD data at baseline was recorded from an exercise test, the same test displayed in the first period of training sessions (warming up phase of 5 minutes on the treadmill, 20 minutes of active phase, and cooling down phase for a period of 5 minutes). At the 12th, 30th and 48th week, MWD was recorded from the training session in the corresponding week.
Secondary outcome measures
Adherence, defined as the completion of the protocol, was measured at the end of the protocol
Overall study start date
12/03/2006
Overall study end date
25/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 60 and 70 years
2. Non-smokers or former smokers for more than 5 years
3. Good general health (without neuromuscular, orthopaedic, neurological or cardiopulmonary conditions)
Participant type(s)
Healthy volunteer
Age group
Senior
Sex
Both
Target number of participants
Eighty four patients were selected for allocation
Participant exclusion criteria
1. Neuromuscular diseases
2. Orthopaedic diseases
3. Neurological diseases
4. Cardio-pulmonary diseases
5. Any chronic deficit that would prevent exercise
Recruitment start date
15/10/2010
Recruitment end date
25/01/2011
Locations
Countries of recruitment
Egypt
Study participating centre
Dar El Salam General Hospital
ENT & Ophtalmology Centre
Cairo
11611
Egypt
Sponsor information
Organisation
University of Córdoba (Spain)
Sponsor details
Department of Morphological Sciences
Avda. Menéndez Pidal
s/n
Córdoba
14071
Spain
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
University of Córdoba (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dar El Salam General Hospital (Egypt)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Paper submission in progress. Later, we would like to participate in a Geriatric Congress with some poster or communication.
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/05/2016 | Yes | No |