Define internal and external validity and come up with threats to both when you have a study where you measure maximal oxygen uptake before and after a training program over 3 years in a group of obese, untrained subjects 13 years of age. Task II

 

Task I

Define internal and external validity and come up with threats to both when you have a study where you measure maximal oxygen uptake before and after a training program over 3 years in a group of obese, untrained subjects 13 years of age.

Task II

You are about to design a study where you would like to determine whether a high fat/low carbohydrate diet influence exercise capacity and vascular function.

Design the study and write a:

  1. Research protocol (maximum 3 pages including references)
  2. Informed consent (maximum 3 pages)
  3. And discuss the following ethical concerns from the ethical committee application
    1. Research ethical challenges with the project
    2. Advantages in participation for:
      1. Subjects
      2. Group of persons
      3. Society
      4. Science ii. Disadvantages for:
      5. Subjects
      6. Group of persons
    3. Discuss actions you will take to secure and protect your subjects
    4. Discuss how to secure and store data and maintain subject confidentiality
  4. You have performed the study and you are about to write the paper to get it published into an international journal. What is required to become a co-author on your paper?

Task III

You are about to design a study where you compare the effect of two programs of endurance training upon maximal oxygen uptake; interval training (10×1 minutes) or a isocaloric program of moderate continuous exercise.

You are given the following information: A clinical relevant difference in maximal oxygen uptake between two groups is 3 ml/kg/min and standard deviation for measuring maximal oxygen uptake in your laboratory is 5 ml/kg/min. Use power of 0.90 and (a two-tailed) pvalue less than 0.1

How many subjects do you need in each group to detect a real difference in training response between the two programs?

Task IV

We have got a new system (OxyNew) for measuring maximal oxygen uptake in the laboratory that is much easier to use than the old apparatus (Gold Standard). The following data for maximal oxygen uptake were collected (data are in mL/kg/min):

Gold

Standard OxyNew
55 50
60 66
25 32
36 33
87 89
85 86
33 42
24 24
11 16
55 55
56 66
58 53
59 56
70 90
82 86
78 94
67 78
68 66
67 72
72 66
54 48
37 37
44 46
42 52
39 38
33 30
33 39
32 26
28 35
24 30
41 48
42 34
53 56
57 52

How would you evaluate the strength of relation and agreement between the results for the two systems? Plot this in figures and gives numbers and explain why one expression form may be better than the other.

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