Effect of Supervised in Comparison to Non-supervised Multicomponent Exercise Training on Balance and Quality of Life in Peripheral Diabetic Neuropathy

NCT06964542 | Completed

• 1 other identifier: FUI/CTR/2024/63
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THIS STUDY IS TO DETERMINE THE effect of supervised in comparison to non-supervised multicomponent exercise training on balance and quality of life in peripheral diabetic neuropathy

Conditions

Peripheral Diabetic Neuropathy

Keywords

Endurance; Multicomponent exercise training; Diabetes Mellitus; Peripheral Diabetic Neuropathy

Outcome Measures

Primary Outcomes (3)

• Balance

  Berg balance scale. The score range is 0-56, with higher scores indicating better balance and functional mobility.

  4 weeks

• Strength

  The MMT scale refers to the Manual Muscle Testing scale, a standardized method used by physical therapists and healthcare providers to assess muscle strength. It has 6 grades.

  4 weeks

• ENDURANCE

  6-Minute Walk Test (6MWT) ) is a widely used and validated test to assess endurance.

  4 weeks

Study Arms (2)

Supervised Group

EXPERIMENTAL

In supervised exercise intervention a multicomponent exercise training will be applied to group 1 patients for improveent of symptoms caused from diabetic peripheral neuropathy such as balance, endurance, strength and quality of life. Strength and resistive training along with aerobic and balance training will be applied to patients under the supervision of physical therapist in a clinical setup.

Procedure: Multicomponent exercise intervention

NON SUPERVISED

EXPERIMENTAL

In non-supervised exercise training, patients will receive multicomponent exercise intervention without the supervision of physical therapist but still under the supervision of caregiver at home. Patients will be provided with the complete guidance in the form of exercise diary. This diary included all the protocols for exercise at home , it also included QR code.

Procedure: Non Supervised

Interventions

Multicomponent exercise intervention PROCEDURE

Patient will be under the complete supervision of physical therapist in a clinical setup.A total of 18 sessions of supervised multicomponent exercise training, thrice a week on alternate days for 6 consecutive weeks, session will be of 45 mins. Multicomponent exercise training including strength and progressive resistance training exercises, actvities will inc. Seated Marching,heel raises,toe raises, sit - to-stand. And balance training activities will involve tandem stands,single leg stance,weight shifting and resistance activities including weight lifting according to feasibility.

Supervised Group

Non Supervised PROCEDURE

In non supervised group , patient will receive all the intervention with the help of exercise diary and guidance provided by the physical therapist. Patient will perform 18 sessions, thrice a week on alternative days, for 6 consecutive days for 45 mins. In diary patient is provided the tick mark table in which patient will mark the attendance on days ptn will perform the exercise. Diary is a complete guidance for home based exercise program which include QR based videos of performance of all exercises and complete guidelines are provided in urdu for the better understanding along with pictorial information. In this program activities that patient will perform includes; stairs climbing, sit to stand, leg raises, side stepping, leg raises with weight on ankles starting from 1kg to 3kg. Walk starting from 20 minutes to 40 minutes till 6 weeks. Resistance and other activities will be included.

NON SUPERVISED

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-70 years (both male and female)
• Diagnosed patients of diabetes type 2, 10 years after disease
• Completely assessed with Michigan Neuropathy Screening Instrument (MNSI) score scale and patients fulfilling this criterion will be included in this study
• Patients who are fulfilling PARQ will be included in study

You may not qualify if:

• Hypoglycemia
• Patient having ischemic heart diseases will not be included
• unable to walk independent
• major orthopedic problems (e.g. lower limb fractures)
• Diagnosed neurological and psychological patients

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: September 10, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 30, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

PA (1)