Skip to main content
OpenTrials
Completed

NCT Number: NCT06964542

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Balance

    Time frame: 4 weeks

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

  2. 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.

  3. ENDURANCE

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 9, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.