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Abstract
Objective To determine the effects of multifactorial inspiratory muscle training (IMT) combined with Otago Exercise Programme (OEP) on balance and quality of life (QoL) in patients with diabetes.
Methods Pretest–post-test randomised controlled trial.
Setting Rehabilitation Department of Pakistan Railway General Hospital.
Participants 70 patients with diabetes were randomly assigned to experimental or placebo groups, out of which 59 patients completed the intervention.
Intervention Patients in the experimental group performed OEP+IMT (at 50% of baseline maximum inspiratory pressure (MIP)) whereas the placebo group performed OEP+sham IMT (at 15% of MIP). Both groups exercised for 12 consecutive weeks.
Outcome measures Outcome measures included nine variables: the Berg Balance Scale (BBS), the Biodex Postural Stability System (including postural stability test (Overall Stability Index, Anterior–Posterior Index and Mediolateral Index), fall risk test (FRT), Limits of Stability (LOS) test (time to complete test and direction control), Clinical Test of Sensory Interaction and Balance (CTSIB)) and the Audit of Diabetes Dependent Quality of Life questionnaire.
Results Out of 59 patients who completed treatment, 37.1% were men and 62.9% were women with a mean age of 58.37±5.91 years. Results show significant interaction effects on BBS scores with the mean score improving from 41.87±2.61 to 49.16±2.50 in IMT versus sham IMT group with scores improving from 41.58±2.51 to 45.74±2.30. The IMT group significantly improved in dynamic balance tested through BBS (p=0.003), anticipatory balance through LOS test (p=0.003), reactive balance tested through FRT (p=0.04), direction control (p=0.03) and sensory integration through CTSIB test (p=0.04) when compared with the sham IMT group. While no significant changes (p>0.05) between groups were observed in QoL and static balance; significant changes (p<0.05) within group were observed in both groups in QoL and static balance.
Conclusion Additional research is necessary to understand the association between inspiratory muscle strength and balance, however, we demonstrated that a multifactorial IMT intervention should be used with patients with diabetes to improve balance, postural control and reduce fall risks.
Trial registration number ClinicalTrials.gov, NCT#04947163.
- Quality of Life
- Quality in health care
- Diabetic nephropathy & vascular disease
- Diabetic neuropathy
- Health
Data availability statement
Data are available upon reasonable request. Anonymised, individual participant data that underlie results reported in this article will be shared on request (at suman.sheraz@riphah.edu.pk) as an excel file immediately after publication until 36 months of publication as per policy of university. Later, it will be available on university repository. Study protocol and analysis plan are also shared as supplementary files.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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- Quality of Life
- Quality in health care
- Diabetic nephropathy & vascular disease
- Diabetic neuropathy
- Health
Data availability statement
Data are available upon reasonable request. Anonymised, individual participant data that underlie results reported in this article will be shared on request (at suman.sheraz@riphah.edu.pk) as an excel file immediately after publication until 36 months of publication as per policy of university. Later, it will be available on university repository. Study protocol and analysis plan are also shared as supplementary files.
Supplementary materials
Supplementary Data
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Footnotes
X @sumansherax, @fferraro5
Contributors All the authors met the ICMJE criteria for authorship. Conceptualisation, ANM and SS; methodology, FAS and SS; validation, SS, ANM and FAS; formal analysis, SS and FVF; investigation, SS and FAS; resources, FAS and ANM; data curation, FAS and SS; writing—original draft preparation, SS and FVF; writing—review and editing, ANM and FVF; visualisation, FVF and SS; supervision, FVF and ANM; project administration, ANM and SS. All authors have read and agreed to the submitted version of the manuscript. The guarantor of the study is corresponding author (SS); accepts full responsibility for the finished work and the conduct of the study, had access to the data and controlled the decision to publish.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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