Clinical trial NCT03563261: Muscle-Tendon Mechanics During Locomotor Tasks, Efficacy of Collagen Supplementation for Older Adults
Official title: Interactions of Muscle-Tendon Mechanics During Stair Climbing and Trip Recovery, and Efficacy of Collagen Supplementation for Functional Improvement for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendon Stiffness With Age
Keywords: Older Adults
Collagen supplementation
Locomotor behaviour
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized control study
Primary purpose: TREATMENT

Brief summary: Older adults are at higher risks of tripping and falling than young adults. These falls may lead to serious injuries (bone fractures, head trauma...) and premature death. They also have an important economic cost for the society. One of the reasons identified for this increased risk of falling is the modification of muscles and tendons functional and architectural parameters with age. It is now well established that muscles of older adults are smaller and weaker, while tendons, that modulate the outcomes of muscle contraction, are less able to resist to tension and transmit forces more slowly than in young age. These changes have functional implications, especially in tasks that require to quickly generate high forces, such as recovering from a trip.

This study aims to determine the links between muscle-tendon characteristics and locomotion, and to understand whether they can be improved by a four-months collagen supplementation.

The investigators will measure the muscular strength and tendon stiffness of lower limb musculotendinous units (MTU) for older adults using isokinetic dynamometry (IKD) and ultrasounds. Participants' abilities to recover from a trip will then be evaluated using a custom built tripping device while walking on a treadmill (participants will wear a whole body harness attached to a rope secured to the ceiling). These performances will be linked to MTU characteristics and compared between both age groups. Finally, the investigators will evaluate the effect of a nutritional supplementation on the mechanical properties of elderly tendons and its potential impacts on their ability to safely recover from a trip, on their lean mass, and on other life quality related markers (joint pain, balance, stair climbing capacities...).

The investigators expect that this study will lead to a new intervention aiming to improve the safety of older adults performing their daily activities using nutritional supplementation, which is known to have better adherence than training interventions.

Detailed description: Being able to walk safely, to go up and down stairs and to recover from an unexpected gait perturbation are vital for older adults' autonomy, home maintenance and life quality. It is therefore of major interest to understand the mechanisms responsible for older adults (OA) decreased functional abilities. This study aims first to understand the links between muscles and tendons characteristics and functional capacities of OA, and second to evaluate whether a 4-month collagen supplementation can improve OA musculotendinous properties, thereby improving their function.

Trips are caused by an unexpected perturbation during the swing phase of gait (i.e. when the foot is not in contact with the ground). Recovering from a trip requires the production of fast and large muscle torques at the hips, knees and ankles joints to counteract the forward rotation of the body, and the propulsion of the forward leg anteriorly to the centre of mass.

For OA, falling when walking on a flat surface is potentially damaging, and falling while using stairs is even more dangerous. Indeed, over 65% of falls leading to brain injury in OA happen in stairs and 10% of fall death in the US happen in stairs. Older adults with joints problem are more susceptible to report difficulties when using stairs than those without. Those with multiple joints problems are also up to 20 times more likely to have difficulties in stair climbing than OA without joint problems. Mechanically, older adults operate closer to their maximal joint moment capacities at the knee (ascent and descent) and ankle (ascent). They thus have less reserve to adjust to any perturbation that could happen and are at more risks of falling than young adults (YA).

Normal gait, but also trip recovery and stair climbing are dependent on the muscles and tendons capacities to produce and transmit adequate forces in a short amount of time.

With age, muscular and tendinous properties decline: muscles, that are responsible for the production of forces, become weaker and smaller, and tendons, that are responsible for the transmission of forces from muscles to the skeleton, become less stiff. It has been shown that changes in the gastrocnemius tendon's properties affect the ability of elderly to maintain balance during dynamic and demanding postural tasks, complicating OA daily living activities. This may especially be so when the individual is not only required to generate large joint moments, but to do so quickly, as is the case when trying to avoid a fall. OA with decreased muscle and tendon properties do not generate and transmit adequate forces in magnitude and velocity, which may be responsible for their decreased ability to recover from a trip and in some cases may lead to falls. Therefore, interventions that improve muscle-tendon properties of OA are likely to have benefits for recovering from a trip and preventing a fall occurring.

Training interventions have been developed to minimise the effect of age on OA physical condition but although strength training can improve tendon stiffness and muscle strength, participants' adherence to these protocols can be low. Developing interventions with similar effects and which are easier to follow (that do not require modification of participants' routine) is thus of major interest.

It has been shown that collagen supplementation improves the blood collagen synthesis and the resistance to tension of collagenous tissues in the body. In this study, the investigators will test a collagen supplement designed to improve joint, muscle and whole-body function.

Although the investigators understand that the structure of muscles and tendons determines their function and has key roles in overall physical function and ability to recover from a trip, the investigators do not yet fully understand these mechanisms and how best to improve them. The research area will be centred upon the muscle-tendon properties and interactions that determine physical function in two different conditions (stair climbing and trip recovery), and whether these can be improved by collagen supplementation.

The investigators will therefore evaluate changes in bone mineral density, lean mass, tendon stiffness, muscle strength, stair climbing and tripping recovery capacities before and after a 4-month supplementation period in 80 OA allocated either to the active product or to the placebo group.

Eligibility criteria: Inclusion Criteria:

* Men and women over 50 years
* Mean age: maximum 65 years

Exclusion Criteria:

* Any lower limb injury in the last 6 months
* A joint replacement
* Neural, musculoskeletal or balance disorder that could affect the musculoskeletal system or capacity to execute functional tasks
* Be taking any nutritional supplements that affect muscle or tendon size or function or stopped its intake less than 3 months before the baseline
* Presence of systemic diseases (e.g., diabetes mellitus or cardiovascular, kidney, liver or lung disease)
* Pregnant or breast feeding
* History of drug abuse
* Taking anti-inflammatory medication within 24 hours the baseline
* Allergic to any ingredient in the test products (meat, fish or soy)
* Concurrent participation in other clinical studies
* 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)

Primary outcomes:
measure: Tendon stiffness
timeFrame: at baseline and after the end of the supplementation period (4-months)
Secondary outcomes:
measure: Rate of torque development (RTD)
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Muscles strength
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Muscle length
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Fascicle length
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Muscle cross sectional area
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Pennation angle
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Tendon length
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Tendon cross sectional area
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: EMG (Electromyography) activity
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Electromechanical delay
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Whole body bone mineral density
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Lean mass
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Balance
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Participants' confidence for activities-specific balance tasks
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Knee scoring scale
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Joints pain
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Participants' perceived risk of falling
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Participants' health perception
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Trip recovery: step length
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Trip recovery: margin of stability
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Trip recovery: number of steps required to be back to baseline
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Trip recovery: joint moments
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Trip recovery: joint power
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Trip recovery: EMG activity
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Trip recovery: MTJ displacement
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Stair climbing: centre of pressure to centre of mass distance
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Stair climbing: pain level
timeFrame: at baseline and after the end of the supplementation period (4-months)
measure: Stair climbing: confidence level
timeFrame: at baseline and after the end of the supplementation period (4-months)
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University - Tom Reilly Building
Study officials:
affiliation: Liverpool John Moores University
name: Thomas O'Brien, PhD
role: STUDY_DIRECTOR
References: