Prescription Methods in Pulmonary Rehabilitation - Essay Example

Participant Information Sheet Does tailoring of a pulmonary rehabilitation programme with maximal exercise capa test data results in better outcomes? A pilot study Participant Information Sheet: Title of the project: Does tailoring of a pulmonary rehabilitation programme with maximal exercise capacity test data results in better outcomes? A pilot study Lay Title: “Comparison of two exercise prescription methods in pulmonary rehabilitation”. Invitation to participate: The main goal of this study is to compare between two exercise presciption methods in pulmonary rehabilitation. You are invited to participate in this research project but whether to participate or not is entirely your decision. Whether you take part or not, your medical care with the services which you recieve will not be affected in any way. Selection: You have agreed to participate in a pulmonary rehabilitation at the Repatriation General Hospital. Therefore, we would like to invite you to take part in our research project. Aim of the project: In this research project, we will evaluate the effects of two different ways to deliver pulmonary rehabilitation. The difference between the two approaches is that in one program, we will do one extra test prior to the start of the program: a maximal exercise cycle test on a stationary bike. The results of this test will give us more specific data regarding your fitness and cardiac health that will be used to further customise your pulmonary rehabilitation program. In 2014, all the patients, who participate in pulmonary rehabilitation at the Repatriation General Hospital, will be asked to do this maximal exercise cycle test as part of the standard pre pulmonary rehabilitation assessment. Data of this test will be used to further adjust your pulmonary rehabilitation exercises. If you participate in this research project, there is a 50% chance that you will and a 50% chance that you will not get this maximal exercise cycle test (we will decide this with the help of a computer program). If you will not be asked to do the maximal exercise cycle test, you will be offered the same pulmonary rehabilitation program that has been offered in the Repatriation General Hospital until the end of 2013. Instead of the maximal exercise cycle test, data of the walk test will be used to fit the pulmonary rehabilitation program. Programs without maximal exercise cycle test are offered in most of the centers around Australia. At the end of 2014, we will evaluate, whether the use of the extra maximal cycle test leads to further increase of the effects of pulmonary rehabilitation. If this is the case, the standard use of the maximal exercise cycle test will be continued. If not, we most probably decide to go back to the previously used pulmonary rehabilitation approach. Summary of procedures: If you agree to particiate, we will use the measurements that will be done as part of your pulmonary rehabilitation measurements (at the start, by the 8th week, and end of the program). So, you will be asked to do three sets of measurements: before the start of the program, after 8 weeks, and at the end of the program. All measurements include: completing a set of questionaires, a walking test, and breathing test. The cycle test will be done only if you are assigned to the cycle test group. Questionaires: You will receive a set of surveys that measure your overall health status, disability and how you are feeling. These surveys are in multiple choice format where you asked to choose the response that best decribes your situation. The surveys will be mailed to you or you can fill it out during your visit for your initial assessment. Completing the qustionnaires will take approaximately 45 minutes. Walking test: You will be asked to walk as many meters as you can in 6 minutes. You will walk back and forth in a corridor and are permitted to slow down, to stop, and to rest if necessary. For the first assessment you need to perform this test twice, with an appropriate time to rest in between. Breathing test: Your lung function will be determined with a breathing test (spirometry). You will be asked to take in a maximal breath and blow the air out as hard and as fast as you can into a mouthpiece. The test will be repeated in 15 minutes after Ventolin is administered to assess if there is any change in your lung function. Ventolin is an inhaled medicine called a fast-acting bronchodilator. which may open the airways in your lungs so that you can breathe more easily. Cycle ergometer test: You will perform this test if you are assigned to cycle test group (intervention group). In this test, you will be asked to perform cycling on a stationary bike that is gradually loaded. Heart tracing wires will be placed on your chest to monitor your heart function. You will breathe through mask during the test to evaluate your breathing. The oxygen level in your blood will be monitored as well. Prior to start the test, you will be asked to rate your shortness of breath and leg fatigue on a scale of 0 to 10. Then, you will start pedaling with no load for 3 minutes. After that you will continue pedaling with pedaling rate of 65-70 revolutions per minute until you are exhausted. We will ask you again to rate your breathing and leg fatigue during and after the test. Pulmonary Rehabilitation program: After you have done your initial assessments, you will be informed when to start with your pulmonary rehabilitation program. You program is a 12-week program. In the first 8 weeks you will attend one 2-hour education session and two 60-minute exercise sessions per week. During the last 4 weeks you will continue with two 60-minute exercise sessions, but you do not have any further education sessions. The education sessions are lecture-based, where you will learn more about the disease and how to manage it. You will also learn how to exercise at home and what diet is best for you. It will provide you with self-management skills that you can use to minimize your symptoms. The exercise sessions are the set of exercises depending on your goals. You will have individualized training design to improve your physical activity. The exercises will consist of one or more of the following: Cycling exercises for upper and lower limbs. Walking exercises on treadmill. Walking stairs. Lifting weights. You will also be asked for permission to access your medical records for the purpose of retrieving information. Commitments: In addition to the commitments that you have because you are participating in the pulmonary rehabilitation program of the Repatrition General hospital (two sets of measurements, maximal exercise cycle test, and attending the program twice a week for 12 weeks), you will have to attend one extra set of measurements after 8 weeks. This extra measurement wil take approximately 1.5 hours. What will happen to me at the end of the study? After the end of the study, your GP will continue your health care plan. We will contact you after six months for follow up. Risks: Like in any usual exercises, You may feel increase in your shortness of breath, muscle soreness, and leg fatigue. In addition more rare events can occur: changes in blood pressure, heart rate, and fainting. In extremely rare cases, a heart attack or stroke has been reported. Trained staff and emergency equipment will be available if any of these take place. During the breathing tests (spirometry), you may have shortness of breath, tremor or shakiness, coughing, light-headedness or fainting, and/or chest tightness. Normally if you experience any of these side effects you should recover within a few minutes. If these side effects persist you will receive medical treatment. Benefits: This study will define, whether a more tailored exercise prescription will lead to better outcomes. This is important knowledge to optimise future programs. We believe that both pulmonary rehabilitation approaches will be effective, however the approach that used the maximal exercise cycle test might lead to further increased benefits or adverse events/complications. Compensation: Participation in this study does not influence your basic legal right to seek compensation; however, if you do suffer harm, you may receive compensation without litigation. Confidentiality: All records containing personal information will remain confidential and no information, which could lead to your identification will be released, except if required by law. Tissue samples: There will be no tissue samples. Publication: The project outcomes may be published in conference papers, journals or other venues as appropriate. Withdrawal: You may withdraw from this study if you want and your care will not be affected in any way. Outcomes: The results of the study may be obtained on request of Dr. Khaled CONSENT TO PARTICIPATION IN RESEARCH I, (first or given names) (last name) give consent to my involvement in the research project Comparison of two exercise prescription methods in pulmonary rehabilitation (short title) I acknowledge the nature, purpose and contemplated effects of the research project, especially as far as they affect me, have been fully explained to my satisfaction by (first or given name) (last name) and my consent is given voluntarily. I acknowledge that the detail(s) of the following has/have been explained to me, including indications of risks; any discomfort involved; anticipation of length of time; and the frequency with which they will be performed: 1. Assessments including walking test, breathing test, and surveys before the start, after 8 weeks and at the end of the pulmonary rehabilitation program. 2. Cycle ergometer test (if you are allocated to the intervention group). 3. Attendance to education sessions and training sessions . I have understood and am satisfied with the explanations that I have been given. I have been provided with a written information sheet. I understand that my involvement in this research project may not be of any direct benefit to me and that I may withdraw my consent at any stage without affecting my rights or the responsibilities of the researchers in any respect. I declare that I am over the age of 18 years. I acknowledge that I have been informed that should I receive an injury as a result of taking part in this study, I may need to start legal action to determine whether I should be paid. Signature of Research Participant : Date: I, have described to the research project and nature and effects of procedure(s) involved. In my opinion he/she understands the explanation and has freely given his/her consent. Signature: Date: Status in Project: Read More