Clinical trial NCT06046885: Electrical Stimulation in Older Adults
Official title: Effect of a Neuromuscular Electrostimulation Protocol on the Triceps Surae in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aged
Lead sponsor: University of Gran Rosario
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Within the problems associated with population aging and its morbidities, the musculoskeletal system is involved in detrimental changes, compromising, in many cases, the functional capacity of the patient and their correct performance in the activities of daily living. Gait and stability are central axes to analyze and enhance in the elderly patient. Strategies for magnify these qualities are innumerable, although active exercise and electrostimulation comprise the most scientifically developed. Therefore, the objective of this study is to evaluate the effects of an electrostimulation (EE) program applied to the triceps surae in older adults on the temporo-spatial parameters of gait, stability and function.

Detailed description: This is a quasi-experimental study with a sample of 13 volunteers. Patients of both genders and over 60 years old will be potential candidates for participating in the study. Volunteers will be invited to participate in the study through social networks and e-mail.

The study will be conducted in 12 experimental sessions on different days and 2 assessment days. During assessment sessions several measurements will be performed, including: balance (will be assessed using a balance tracking system balance plate) function (will be assessed by using the Short Physical Performance Battery) and gait (will be assessed using the Legsys device employing a 4 meter walk test).

The G-Power program (version 3.1.5, Franz Faul, Universität Kiel, Kiel, Germany) was used to perform the one-tailed sample calculation using a previous study . The isometric strenght of gastrocnemius was chosen as the main variable with an effect size of 0.70. The alpha level was set at 5%, and the estimated sampling power was 80%. The software returned a total sample of 13 individuals.

Eligibility criteria: Inclusion Criteria:

. To have signed the informed consent.

Exclusion Criteria:

* Surgical history of the lower extremities
* Uncontrolled neurological, metabolic disease
* Uncontrolled cardiac disease
* Uncontrolled respiratory disease

Primary outcomes:
measure: Change in ankle plantar-flexion strength
timeFrame: At baseline and 6 weeks later
Secondary outcomes:
measure: Function
timeFrame: At baseline and 6 weeks later
measure: Function
timeFrame: At baseline and 6 weeks later
measure: Change in balance
timeFrame: At baseline and 6 weeks later
measure: Change in handgrip strength
timeFrame: At baseline and 6 weeks later
measure: Change in gait speed
timeFrame: At baseline and 6 weeks later
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: University of Gran Rosario
state: Santa Fe
Study officials:
References: