CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Inspiratory Muscle Training +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04947163
NCT04947163N/ACompleted

Effects of Inspiratory Muscle Training (IMT) on Balance Ability and Quality of Life of Diabetes Mellitus Patients

Riphah International University·interventional·Posted Jul 1, 2021·Updated Mar 5, 2024

In Brief

A clinical study evaluating Inspiratory Muscle Training and Sham IMT for Diabetes Mellitus. Completed, enrolled 62 participants across 1 site.

Detailed Summary

The disease burden of Diabetes Mellitus (DM) is growing rapidly, and multiple complications have been reported including cardiopulmonary and high fall risk which declines the overall quality of life. IMT can be useful technique to improve the physical and functional performance, reduce the severity of complications and enable the individuals to become active members of community. The current study is intended to evaluate the dual effects of IMT on postural stability and pulmonary function of diabetic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPakistan
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 1, 2021
Enrollment StartJul 1, 2021
Primary CompletionDec 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.0 years ago

Interventions

Inspiratory Muscle Trainingdevice

Participants will perform home-based IMT twice daily \[once in the morning (between 7:00 and 12:00 am) and once in the evening (between 16:00 and 21:00 pm)\], for 8 consecutive weeks, using a mechanical pressure threshold loading device. In addition, participants in this group will try to increase the inspiratory resistance when the participants feel that 30 breaths are achievable with ease or if the participants could reach 35 consecutive breaths.

Sham IMTdevice

Participants will perform 60 slow breaths once daily at a load setting of 0 (corresponding to \~15% \[baseline\] MIP), using the same device as the IMT group. For the sham group, the ability to adjust the training load will be prevented using sticky tape applied to the device's load adjuster.