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

December 24, 2025 updated by: Foundation University Islamabad
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Effect of exercises to assess the benefits on strength endurance, balance and mobility.

Peripheral Neuropathy aged 55-70 will be recruited in the study. The participants would be assessed through WHOQOL BREF, BERG BALANCE SCALE, TIME UP AND GO TEST .

Informed Consent will Be taken after which the participants will be recruited into the two groups, where one group will receive supervised exercise intervention while other group will receive non supervised exercise intervention

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Foundation University College of Physical Thrapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised Group
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
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.
Experimental: NON SUPERVISED
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: 4 weeks
Berg balance scale. The score range is 0-56, with higher scores indicating better balance and functional mobility.
4 weeks
Strength
Time Frame: 4 weeks
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
Time Frame: 4 weeks
6-Minute Walk Test (6MWT) ) is a widely used and validated test to assess endurance.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2024

Primary Completion (Actual)

May 15, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

May 1, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 24, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2024/63

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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