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Effect of laser therapy on the physical capacity of patients with type 2 diabetes

Acute effect of Low Power Laser (red and infrared) on the performance of patients with peripheral arterial disease in the walk test: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4mhhqzk
Enrollment
Unknown
Registered
2022-09-12
Start date
2021-10-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Type 2 Diabetes Mellitus patients on regular treatment, both sexes, between 45 and 75 years old will be invited to participate in this study. After initial standardized evaluation, those included (n=3
10 each group) will be randomly distributed (online) among 3 groups: Red Laser (660 nm), Infrared Laser (830 nm) and Laser Placebo (no energy emission). Photobiomodulation will be applied at 6 standar
Power: 30mW: Contact Area: Red: 0.0631 cm² and Infra: 0.116 cm²
Energy per point: 2J
Energy per limb: 12 J). All equipment will be tested weekly to verify the emission power and adjustments, if necessary. The baseline intervention for all groups will be foot injury prevention counseli
E02.774

Sponsors

Universidade Estadual do Oeste do Paraná
Lead Sponsor
Universidade Estadual do Oeste do Paraná
Collaborator

Eligibility

Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Type 2 Diabetes Mellitus under treatment (presentation of a medical prescription containing the prescription of oral hypoglycemic agent and/or insulin); Both sexes; Between 45 and 75 years of age; Residence in the same city of the research

Exclusion criteria

Exclusion criteria: Physical limitation (orthopedic, neurological or ophthalmic) to perform the physical tests (pain above 5 on the visual scale, disability or noticeable change in gait, amaurosis); Peripheral neuropathy from another cause (Hansen's disease, alcoholism or other); Symptomatic peripheral arterial disease (ankle-brachial index < 0.9 with interruption of any physical test due to claudicating pain); Painful ulcer anywhere on the lower limbs at the time of the first evaluation or during any stage of participation in the project; Amputation above the transmetatarsal; active plantar ulcer or use of implantable electrical device (contraindications for Bioimpedance); BMI = 40 kg/m2; Hospitalization in the 2 months prior to the start of the research, for any reason; COVID-19 diagnosed by examination: in the last 3 months (without hospitalization); within the last 6 months (with hospitalization without intubation) or any period prior to the survey (if intubated) or having post-COVID symptoms (regardless of the period of infection); Supervised physical exercise or treatment with electrical stimulation or phototherapy applied to the muscles of the lower limbs in the 6 months before the start of the research; Two absences from application sessions (consecutive or interspersed) while participating in the project.

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be the usual (self-selected) walking speed in m/s obtained by averaging 3 tests performed in a flat, covered corridor (27 meters) with the patient walking at their preferred speed (timed in seconds).

Secondary

MeasureTime frame
The Triceps Sural Muscle Resistance will be evaluated by the Heel Elevation Test, performed in orthostatism and with bipedal support. The participant must perform as much plantarflexion as possible (predetermined) and at the highest speed to achieve fatigue. The elevation rate (number of elevations/time in seconds) will be used for analysis (best rate between two tests performed on the same day).;The submaximal exercise capacity will be evaluated by the greatest distance covered in the 6-minute walk test (m). Two tests will be carried out on the same day in a 27-meter flat corridor, with a standardized voice command, and the best test (greater distance) will be used to analyze this variable.;The calf circumference will be measured at 30% of the distance between the interarticular line of the knee to the superior edge of the lateral malleolus of the ankle. The circumference of this point, measured in centimeters, will be used to analyze the perimeter of the dominant limb.

Countries

Brazil

Contacts

Public ContactFrancyelle Soares

Universidade Estadual do Oeste do Paraná

franfisio@hotmail.com+5545999514849

Outcome results

None listed

Source: REBEC (via WHO ICTRP)