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The Effects of a Three-week Exercises Program in Patients with Diabetic Polyneuropathy: Randomized Controlled Trial

The Effects of a Supervised Three-week Exercises Program on Range of Motion and Muscle Strength in Lower Leg and Foot, Gait Parameters, Distribution of Pressure and Force on the Ground During Walking and Sensation in Patients with Diabetic Polyneuropathy: Randomized, Two arm, Parallel, Open Label, Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000844549
Enrollment
82
Registered
2024-07-08
Start date
2021-07-16
Completion date
2022-09-19
Last updated
2024-07-15

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

Conditions

None listed

Brief summary

There is significant evidence supporting the effectiveness of foot-related exercise programs when combined with health-promoting interventions in improving neuropathy signs and symptoms, enhancing gait, restoring foot and ankle joint mobility, redistributing pressure during walking, and increasing foot strength and function. These combined efforts can help mitigate risk factors for diabetic foot ulcers. Considering that diabetic polyneuropathy is a chronic condition, with complications in muscles and joints developing over the long term, preserving and maintaining their integrity is of paramount importance. It is expected that specific interventions could lead to the recovery of muscle and joint function in patients with diabetic polyneuropathy. The objective of this study is to determine the effect of supervised stretching, strengthening, functional, and walking exercises on joint mobility and muscle strength in patients with diabetic polyneuropathy.

Interventions

Brief name: Exercise program Patients in the intervention group received alpha-lipoic acid intravenously at a dose of 600 mg dissolved in 250 ml of 0.9% sodium chloride solution, administered over 60 minutes once a day for 15 consecutive therapy days, excluding weekends. Additionally, they participated in a 50–60-minute daily exercise program for 15 consecutive therapy days, excluding weekends. The intervention comprised a specific one-on-one kinesiotherapy program consisting of four exercise

Brief name: Exercise program Patients in the intervention group received alpha-lipoic acid intravenously at a dose of 600 mg dissolved in 250 ml of 0.9% sodium chloride solution, administered over 60 minutes once a day for 15 consecutive therapy days, excluding weekends. Additionally, they participated in a 50–60-minute daily exercise program for 15 consecutive therapy days, excluding weekends. The intervention comprised a specific one-on-one kinesiotherapy program consisting of four exercise blocks, each targeting different objectives: (a) increasing foot and ankle range of motion, (b) strengthening foot and ankle muscles, (c) performing functional (balance) exercises and (d) training walking skills and foot rollover. Each session was composed of some of the exercises from the four exercise blocks. Gradual and progressive difficulty is offered to the patient, respecting any limitation due to pain and/or decrease in performance during execution. In addition, in each session, the exercises were performed following an order that starts with the passive exercises, progresses to active, and finishes with walking and functional skills. The exercises were individually adjusted to each patient, guided and supervised by a physiotherapist. The intensity and speed of performing the exercises are adjusted to prevent pain and discomfort during execution. Each exercise was performed for a specified number of repetitions as described below. After the 15 days program patients were advised to continue with the learned exercises during the next 6 months and no other advice or restrictions were provided. Attendance at exercises and all notes are kept in a diary for each patient individually. During follow-up sessions, a questionnaire was filled out regarding how often exercises were performed at home (yes, no, how many times per week). Range of motion improvement exercises: - Passive stretching of the flexors and extensors of the toes and hallux was performed from a long sitting position, with knees extended and ankles in a neutral position. Flexion and extension of the toes and hallux are performed separately. Each stretching exercise is repeated 5 times, with each repetition held for 30 seconds. - The self-stretching of the triceps surae was performed standing, with the contralateral limb positioned ahead, knee bent, and the ipsilateral limb positioned behind, with the foot facing forward. Each exercise position was repeated 5 times, with each repetition held for 30 seconds. Approximate duration: 15-20 minutes. Strengthening foot and ankle muscles exercises: Muscle strengthening exercises for the toes' flexor muscles were performed from a supine lying position using manual resistance. Additionally, exercises for the intrinsic muscles of the foot involved sitting with the foot flat on the floor, gripping an object with the toes. To strengthen the toes' extensor muscles, exercises were done from a supine lying position with manual resistance and from a sitting position with the foot flat, focusing on toe extension without allowing dorsiflexion. Exercises for the flexors, extensors, invertors, and evertors of the foot and ankle were performed from a supine lying position using manual resistance. Standing on heels and toes was also included, performed for 1 set of 30 repetitions, except for standing on heels and toes which was done for 1 set of 20 repetitions. Approximate duration:15 minutes. Functional (Balance) Training: - Standing on one leg with or without upper limb support, based on patient tolerance, performed 5 times for 30 seconds on each side. - Standing on a rubber disc filled with air with support from both legs, performed 5 times for 30 seconds. - Standing on heels and toes, performed 5 times for 30 seconds. Balance training started with eyes open and progressed to eyes closed. Approximate duration: 7 minutes. Gait training: - Walking over the heels, toes, lateral border, and medial border of feet at preferred speed. - Walking in tandem. - Walking with softening of heel and forefoot contact during normal walking. - Walking while actively grabbing the floor with toes. - Walking with normal foot rollover: heel strike, midfoot contact, lateral forefoot, medial forefoot, and hallux contact. Execution: All walking tasks performed in a straight line at preferred speed for 60 meters each. Approximate Duration: 10-15 minutes.

Sponsors

Institute for Physical Medicine, Rehabilitation and Orthopedic Surgery “Dr Miroslav Zotovic” Banja Luka
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria were as follows: age between 40 to 65 years, diabetes mellitus type 1 or 2 diagnosed for at least five years, stable glycemic control, body mass index ranging between 18,5 and 29,9 kg/m2 (normal and overweight), electroneurographic findings indicating presence of the diabetic neuropathy and ability to walk independently, without any device.

Exclusion criteria

Unstable glycemic control, active diabetic foot ulcer, amputation, central neurological impairments, any other peripheral neurological impairments except diabetic polyneuropathy, orthopedic disease or previous surgery, rheumatology disease affecting movement, severe vestibular and ocular impairments that affect movement, severe nephropathy or diabetic polyneuropathy, presence of unresolved aetiology pain, intermittent claudication, ankle-brachial index value less than 0.8 or greater than 1.2 and presence of malignant disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026