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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN12621097
Date of registration: 03/05/2016
Prospective Registration: No
Primary sponsor: University of Córdoba (Spain)
Public title: Efficacy of treadmill exercises on arterial blood oxygenation, oxygen consumption and walking distance in healthy elderly people
Scientific title: Efficacy of treadmill exercises on arterial blood oxygenation, oxygen consumption and walking distance in healthy elderly people: a non-randomized controlled trial
Date of first enrolment: 15/10/2010
Target sample size: 84
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN12621097
Study type:  Interventional
Study design:  Prospective single-centre non-randomized single-blinded controlled intervention trial (Quality of life)  
Phase: 
Countries of recruitment
Egypt
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: José Luis    Lancho
Address:  Avenida de Menéndez Pidal s/n 14071 Córdoba Spain
Telephone: +34 (0)957 218 256
Email: cm1laalj@uco.es
Affiliation: 
Key inclusion & exclusion criteria
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)

Exclusion criteria: 1. Neuromuscular diseases
2. Orthopaedic diseases
3. Neurological diseases
4. Cardio-pulmonary diseases
5. Any chronic deficit that would prevent exercise


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Aerobic power
Not Applicable
Intervention(s)
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
Primary Outcome(s)
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(s)
Adherence, defined as the completion of the protocol, was measured at the end of the protocol
Secondary ID(s)
1/2007
Source(s) of Monetary Support
University of Córdoba (Spain), Dar El Salam General Hospital (Egypt)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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