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IRCT20201022049110N1 IRCT 2021-02-27 Bojnourd University of Medical Sciences Effect of resistance exercise using TheraBand on balance, timed up and go, and fear of fall in elderly diabetic type 2 patients with peripheral neuropathy Effect of resistance exercises using TheraBand on balance, timed up and go, and fear of fall in diabetic type 2 patients with peripheral neuropathy referring to Iranian diabetes foundation, in the city of Mashhad, 2020 2021-02-19 anticipated 60 Complete https://irct.ir/trial/52101 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Before identifying the eligible participants, 60 random codes in the form of permuted random blocks with different sizes of 2, 4, and 6 for two equal groups will be generated by the software. Then each participants will be given a unique code on their enrolment, and finally they will be allocated to the intervention and control groups based on their random codes. At online software ( https://www.sealedenvelope.com) will be used for permuted block randomization. N/A Balance impairment due to Diabetic type 2 peripheral neuropathy. Intervention 1: Participants in intervention group will perform resistance exercises using TheraBand, four days a week, 30 minutes each day, for twelve weeks. In the first six weeks red TheraBand (weak resistance) and in the last six weeks, green TheraBand (medium resistance) will be used. Exercises include hip flexion and extension, hip adduction and abduction, knee flexion and extension, ankle dorsiflexion, and ankle flexion inward and outward. All movements will be perform in standing and sitting positions. Each movement will be in 3 sets with 10 repetitions. Participants will pause for 2 to 3 seconds between repetitions, 1 to 2 minutes between sets and 2 to 3 minutes between different exercises. Intervention 2: Participants in intervention group will perform resistance exercises without using TheraBand, four days a week, 30 minutes each day, for twelve weeks. Exercises include hip flexion and extension, hip adduction and abduction, knee flexion and extension, ankle dorsiflexion, and ankle flexion inward and outward. All movements will be perform in standing and sitting positions. Each movement will be in 3 sets with 10 repetitions. Participants will pause for 2 to 3 seconds between repetitions, 1 to 2 minutes between sets and 2 to 3 minutes between different exercises. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Saeedeh Baghizadeh
Bojnurd School of Nursing and Midwifery, Shahriar St.
Bojnurd Iran (Islamic Republic of) 7487794149 +98 58 3222 1910 s.baghizadeh@nkums.ac.ir Bojnourd University of Medical Sciences scientific Dr. Mohammad Reza Armat
Bojnurd School of Nursing and Midwifery, Shahriar St.
Bojnurd Iran (Islamic Republic of) 7487794149 +98 58 3222 1910 armat@nkums.ac.ir Bojnourd University of Medical Sciences Iran (Islamic Republic of) Having diabetes type 2 Having peripheral neuropathy with Endocrinologist diagnosis Have physician's permission for exercise Having caregiver during exercises Gaining balance score less than 25 based on the Fullerton Advanced Balance Scale; and less than 32 based on Berg Balance Scale Age between 60-75 years 60 years 75 years Both Gaining score less than 12 in scale for measuring activities of daily living Having diabetic foot ulcer with physician's confirmation Having vision problems R26.8 Other abnormalities of gait and mobility Rehabilitation Rehabilitation Participants in intervention group will perform resistance exercises using TheraBand, four days a week, 30 minutes each day, for twelve weeks. In the first six weeks red TheraBand (weak resistance) and in the last six weeks, green TheraBand (medium resistance) will be used. Exercises include hip flexion and extension, hip adduction and abduction, knee flexion and extension, ankle dorsiflexion, and ankle flexion inward and outward. All movements will be perform in standing and sitting positions. Each movement will be in 3 sets with 10 repetitions. Participants will pause for 2 to 3 seconds between repetitions, 1 to 2 minutes between sets and 2 to 3 minutes between different exercises. Participants in intervention group will perform resistance exercises without using TheraBand, four days a week, 30 minutes each day, for twelve weeks. Exercises include hip flexion and extension, hip adduction and abduction, knee flexion and extension, ankle dorsiflexion, and ankle flexion inward and outward. All movements will be perform in standing and sitting positions. Each movement will be in 3 sets with 10 repetitions. Participants will pause for 2 to 3 seconds between repetitions, 1 to 2 minutes between sets and 2 to 3 minutes between different exercises. Balance score in elderly with diabetic peripheral neuropathy. Timepoint: Study onset, weeks 4, 8, 12, and 16. Method of measurement: Using Fullerton advanced balance scale; and Berg balance scale. Timed up and go in elderly with diabetic peripheral neuropathy. Timepoint: Study onset, weeks 4, 8, 12, and 16. Method of measurement: Implementing timed up and go test. Fear of fall in elderly with diabetic peripheral neuropathy. Timepoint: Study onset, weeks 4, 8, 12, and 16. Method of measurement: Use of short form of International Fall Efficacy Scale (IFES). Bojnourd University of Medical Sciences Approved 2021-01-06 Ethics committee of North Khorasan University of Medical Sciences Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnurd Bojnurd North Khorasan Iran (Islamic Republic of)