Clinical trial NCT05716165: Effect of Proprioceptive Knee Braces on the Performance and Endurance of Recreational Soccer Players Aged 60-80 Years
Official title: Effect of Proprioceptive Knee Braces on the Performance and Endurance of Recreational Soccer Players Aged 60-80 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: knee brace
soccer
aged
Exercise
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, monocentric, randomized clinical investigation (order of tests with and without knee braces), carried out in open, over a period of 2 weeks (cohort 1) or 12 weeks (cohort 2), in a population of people aged 60 to 80 years practicing recreational soccer.
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate the effect of wearing bilateral proprioceptive knee braces on the endurance of subjects aged 60 to 80 years.

Detailed description: Sporting activity has proven health benefits, particularly for older adults, whose balance and neuromuscular functions decline with age.

On the other hand, physical activity in the elderly population may be hampered by inadequate physical condition, muscle or proprioceptive deficits, or fear of falling or injuring. A proprioceptive knee brace could therefore make physical activity safer and thus improve performance, balance, and ultimately the quality of life of the participants.

The objective of the study is to evaluate the effect of wearing bilateral proprioceptive knee braces on the endurance of subjects aged 60 to 80 years.

Eligibility criteria: Inclusion Criteria:

* Subject practicing recreational soccer
* Subject included in the LIBM (inter-university laboratory of motor biology) study: "Effect of recreational soccer practice in persons aged 60 to 80 years"
* Patient whose knee measurements are compatible with the knee brace sizes
* Patient who has signed a free and informed consent form
* Patient affiliated or entitled to a social security plan

Exclusion Criteria:

* Patients with any of the contraindications to the use of the knee brace, as indicated in the instructions for use
* Patient with a major cognitive impairment incompatible with participation in a clinical trial
* Patient participating in another clinical investigation conducted to establish the conformity of a device impacting the judgment criteria
* Vulnerable patient according to article L1121-6 of the public health code, person subject to a legal protection measure or unable to consent freely

Primary outcomes:
measure: Evaluate the effect of bilateral proprioceptive knee braces on the endurance of subjects compared to without knee brace.
timeFrame: week 1
Secondary outcomes:
measure: Evaluate the impact of knee braces on balance compared to without knee brace.
timeFrame: week 1
measure: Evaluate the impact of knee braces on lower limb strength compared to without knee brace.
timeFrame: week 1
measure: Evaluate the impact of knee braces on walking speed compared to without knee brace.
timeFrame: week 1
measure: Evaluate the impact of knee braces on the volunteer's feelings about the stability of his knees, their range of motion, his confidence when walking and his fear of falling after the tests and after the training
timeFrame: week 1, week 2
measure: Evaluate the influence of the functional capacity of the knees of each volunteer at inclusion on the various performance parameters measured
timeFrame: Day 0
measure: Evaluate the satisfaction of the volunteers with the device
timeFrame: Last visit
measure: Evaluate the tolerance of the knee braces
timeFrame: week 1, week 2
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Saint-Etienne Jean Monnet University
Study officials:
affiliation: Saint-Etienne Jean Monnet University
name: Roger OULLION, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baltaci G, Aktas G, Camci E, Oksuz S, Yildiz S, Kalaycioglu T. The effect of prophylactic knee bracing on performance: balance, proprioception, coordination, and muscular power. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1722-8. doi: 10.1007/s00167-011-1491-3. Epub 2011 Apr 6.
citation: Bean JF, Vora A, Frontera WR. Benefits of exercise for community-dwelling older adults. Arch Phys Med Rehabil. 2004 Jul;85(7 Suppl 3):S31-42; quiz S43-4. doi: 10.1016/j.apmr.2004.03.010.
citation: Buchner DM, Cress ME, de Lateur BJ, Esselman PC, Margherita AJ, Price R, Wagner EH. The effect of strength and endurance training on gait, balance, fall risk, and health services use in community-living older adults. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M218-24. doi: 10.1093/gerona/52a.4.m218.
citation: Osoba MY, Rao AK, Agrawal SK, Lalwani AK. Balance and gait in the elderly: A contemporary review. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(1):143-153. doi: 10.1002/lio2.252. eCollection 2019 Feb.