Take part in our study
Interactions of muscle-tendon mechanics during stair climbing and trip recovery, and efficacy of collagen supplementation for functional improvement.
You are invited to take part in a research study. Before you decide to participate, it is important that you understand why the research is being done and what it involves. Please take time to read the following information. Ask us if there is anything that is not clear or if you would like more information.
What is the purpose of the study?
Falls and walking ability are important health, social and economic problems as we age. We know that treatments such as exercise are effective, but they are time consuming and difficult. It is possible that nutritional supplementation improve muscles, tendons and locomotion safety (walking up and down stairs, and recovering from a trip) in an easier and more acceptable way. The purpose of this study is therefore to evaluate the effect of a four month collagen supplementation period on your muscles, tendons and locomotion.
The study is a double blinded randomised control trial. This means that participants will be randomly allocated to a group receiving the active product or a control-group receiving a placebo product. To make sure the research is unbiased, neither you nor we will know who receives which product until the end of the study. This is known as “double blinded”.
Do not worry if you are randomised to the placebo group. If at the end of the study we find that the active product has a positive impact on muscles and/or tendons, we will give you a supply of active products.
Am I eligible?
You may take part in this study if you are aged over 50 years, with or without osteoarthritis.
Unfortunately, you cannot take part in this study if:
- You have suffered an injury, which is affecting your ability to walk (i.e. you now use a walking aid, or have a tendency to limp), or has changed your balance. If you needed a lower limb surgery (in the last two years) for this injury, you cannot participate in this study
- You have had a joint replacement
- You have been diagnosed with a neural, musculoskeletal or balance disorder that could affect your musculoskeletal system or capacity to execute functional tasks
- You are taking any food supplements that affect muscle or tendon size or function or stopped its intake less than three months before the baseline
- You suffer from a systemic disease (e.g., diabetes mellitus or cardiovascular, kidney, liver or lung disease)
- You are pregnant or breastfeeding
- You have a history of drug abuse
- You are allergic to any ingredient in the test products (meat, fish or soy), are vegan or vegetarian (i.e. do not eat meat or fish)
- You are taking medication to treat a chronic disease (e.g., rheumatoid arthritis, psoriatic arthritis, fibromyalgia, gout and inflammatory joint disease for example bursitis or tennis elbow, and any other type of chronic pain syndrome other than osteoarthritis)
- You are on regular NSAID (non-steroidal anti-inflammatory drug), corticosteroids and immunosuppressants
- You have been diagnosed with osteoporosis
If you are unsure about your suitability for this study please speak with us. Contact details are at the bottom of the page.
Do I have to take part?
No. It is up to you to decide whether or not to take part. If you do, you will be asked to sign a consent form. You are free to withdraw at any time and without giving a reason.
What will happen to me if I take part?
If you decide to take part in this research, you will be asked to visit us in the Tom Reilly building of Liverpool John Moores University on two different days: first, to test your muscles’ and tendons’ properties and second, to test your recovering and stair climbing capacities. This will be repeated after the four month supplementation period. We expect each session to length approximately two hours.
On the first day of testing, you will be asked to sign a consent form for your participation to the study, and you will then complete a short questionnaire to confirm that you meet the inclusion criteria for this study. We will record your height and weight on the same day and we will measure your body composition using a DXA scan. DXA is a technique using very small amount of radiation to form an image of your body and provide us information about your bone density, and muscle and fat mass. The radiation exposure is less than a Chest X-Ray and similar to the amount received by passengers during a five hour flight, but greater than in daily life. Female participants will be asked to confirm that they are neither pregnant nor breastfeeding before the scan as radiations must be kept as low as possible during pregnancy. For this test, you will simply lie still on a bed for a few minutes. It is not invasive and you will feel no discomfort. If we find that your bone density is too low to participate further in the study we will give you the report of the screening and will advise you to consult your GP.
On the same day, we will test the strength of the muscles in your legs. We will measure your thigh and shank muscles, and for these you will either be seated or laying on your front, respectively. We will use an ultrasound imaging (the same as used for antenatal scans) to visualise your muscles and tendons while you contract your muscles. It is not invasive so you will experience no discomfort (except for the gel used that can be a little cold). We will also record your muscles activity. To ensure the signal from your muscles is as good as possible; the site of the electrodes will be shaved and then wiped with an alcoholic swab.
On the second meeting (within seven days following the first one), we will evaluate the way you walk in three different conditions (normal walk, stair climbing and induced trips or slips). Before starting, we will ask you to complete five questionnaires (quantifying your perceived balance, degree of concern about your risk of falling, health perception, joints pain) and we will evaluate your balance in a few different tests. We will then measure your walking while going up and down a staircase. You will wear a safety harness and we will put reflective markers on your skin and clothes. Following a few familiarisation trials, we will record motion and force data while you go up and down a staircase five times.
You will then rest before starting the tripping or slipping protocol. We will put electrodes on your legs (same location as shown above) and attach an ultrasound probe to your calf to evaluate the motions of your shank muscle. While you walk we will cause you to feel an effect similar to tripping using straps around your ankles (this test works by applying a very brief and gentle pull on your leg) or by jerking the treadmill belt, and will record your reactions to avoid a fall. These trips or slips are enough to make you feel like you have tripped, but rarely actually causes a trip. We will do this approximately 10 times, but can stop this test at any time you wish. This device has been used many times with older adults without anyone falling to the floor or injury. To further guarantee your safety you will wear a whole body harness. You will be given two minutes of familiarisation before data collection to walk on the treadmill. We will record your normal walking pattern following that familiarisation period and will start testing your reactions to perturbations. The camera system will only detect the reflective markers placed on your body so you will not be identifiable.
At the end of this meeting we will provide you with 60 bottles of supplements. The remaining 52 bottles will be given to you during a meeting in week seven or eight.
The supplementation period will begin the day after the second meeting and will last four months. You will have to drink one bottle (30mL) of supplement every morning before breakfast and to perform five minutes of tendon loading activities (two minutes of heel raise, rest for one minute and two minutes of leg extensions) while seated 30 minutes after ingestion of the product (instructions are provided in the ‘Instructions for taking the supplement’ document). As stated above, you will be allocated to either the active or the control group. Participants in the control group will receive a placebo product which does not contain collagen. However, if at the end of the study we find that the active product has a positive impact on muscles and/or tendons, we will give you a supply of active products.
We will contact you either by phone or by email (as you prefer) after four and twelve weeks of supplementation to make sure that you still take your supplement and to know if there has been any change in your diet or activity level. We will meet you during week seven or eight (time and place convenient to you) to provide you with the remaining bottles of product and to collect the used ones. In addition, we will ask you to record each day in a diary that you have been taking your supplement and have completed the tendon loading activities (see below a typical diary week).
Are there any risks/benefits involved?
After the first session, you may feel some tiredness or aching in the muscles resulting from the effort performed. This is normal and will be similar to normal muscle soreness following exercise; it will last no more than a few days. During the second session, you will be exposed to induced trips or slips that will lead to a temporary instability. It will allow us to study your ability to recover following an induced trip. Theses perturbations will be large enough to cause a momentary instability but small enough to let you recover. To guarantee your safety in case of a fall, you will wear a harness linked to a security system that will stop any possible fall and minimise any risk of you getting injured. You have the right to withdraw from the study at any point during the testing session.
As a participant, you could become aware of some potential risk factors for falling during the variety of tests (balance test) of this project. We will let you know how you perform on the different tests, and based on the things we measure, if you are classed as a high fall risk, we will advise you to speak to your doctor. You may also be aware of a low bone mineral density, if it is the case, we will also advise you to speak with your doctor and we will provide you the report of the DXA screening. By completing the questionnaires, you may also become aware of some problems concerning your perceived social, physical and emotional health, if it is the case, we will advise you to speak with your doctor or a psychologist.
By participating in the study and taking the supplement, you may improve your tendons properties and thus decrease your risks of falling after a trip or a slip. You may also improve your bone mineral density, which would decrease your risk of fracture. Finally, you may improve your balance and decrease your joints pain level.
Will my taking part in the study be kept confidential?
Your name will not appear in any report and will be replaced with a number to guarantee that you remain anonymous.
All data will be stored confidentially and only accessed by members of the research team. At the end of the study, all personal identifiable information will be deleted and the data stored anonymously.
Researcher: Heloise Debelle. Tel: 07490 407 186
If you have any concerns regarding your involvement in this research, please discuss these with the researcher in the first instance.
If you wish to make a complaint, please initially contact the researcher or her supervisor:
Contact Details of Academic Supervisor: Thomas O'Brien
For formal complaints, please contact:
Dr Dave Harris firstname.lastname@example.org. Tel: 0151 904 6236
This study is funded by the LJMU Match Funded PhD Studentship Scheme.
This study has received ethical approval from NHS’s Research Ethics Committee (REC reference: 18/NW/0700)