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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
NCT04947163 |
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Date of registration:
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26/06/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Inspiratory Muscle Training (IMT) on Balance Ability and Quality of Life of Diabetes Mellitus Patients
IMT |
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Scientific title:
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Effects of Inspiratory Muscle Training (IMT) on Balance Ability and Quality of Life of Diabetes Mellitus Patients |
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Date of first enrolment:
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July 1, 2021 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04947163 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Suman Sheraz, PhD* |
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Address:
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Telephone:
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03335646361 |
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Email:
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suman.sheraz@riphah.edu.pk |
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Affiliation:
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Name:
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Imran Amjad, PhD |
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Address:
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Telephone:
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03324390125 |
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Email:
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imran.amjad@riphah.edu.pk |
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Affiliation:
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Name:
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Arshad Nawaz Malik, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Riphah International University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mini Mental State Examination (MMSE) score >24
- Type II diabetes: Post 5-8 years diagnosis
- Berg Balance score (30-40)
- Presence of polyneuropathy confirmed through Modified Toronto Clinical Scoring System.
Exclusion Criteria:
- Patients on oxygen therapy
- Uncontrolled diabetes (Confirmed through HbA1C) or disease exacerbation in last 3
months.
- Patients practicing regular physical activity, any balance training in the last 6
months and previous or current experience with IMT
- Patients with musculoskeletal comorbidities that may impair exercise performance
- Peripheral oxygen saturation (SpO2) < 90% during the Six-Minute Walk Test (6MWT)
- Patients with long COVID syndrome
- Hypertensive subjects without control medication as well as those presenting with a
hypertensive peak (> 140/90 mmHg) for more than 3 consecutive days
- Patients with cardiorespiratory diseases or patients taking drugs that effect balance
e.g., beta blockers, anti-anxiety and anti-depressant drugs.
Age minimum:
50 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Other: Inspiratory Muscle Training
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Other: Sham IMT
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Primary Outcome(s)
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Anterior / Posterior index
[Time Frame: After 6 months of intervention]
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Audit of Diabetes Dependent Quality of Life:
[Time Frame: After 6 months of intervention]
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Fall risk score
[Time Frame: After 6 months of intervention]
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Medial / lateral index
[Time Frame: After 6 months of intervention]
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Modified Clinical Test of Sensory Interaction in Balance (M - CTSIB) (composite score)
[Time Frame: After 6 months of intervention]
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Overall stability index
[Time Frame: After 6 months of intervention]
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Secondary Outcome(s)
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30sec sit-to-stand (30secSTS)
[Time Frame: After 12 weeks of intervention]
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Biering-Sørensen tests
[Time Frame: After 12 weeks of intervention]
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Forced expiratory volume in 1sec (FEV1)
[Time Frame: After 12 weeks of intervention]
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Forced vital capacity (FVC)
[Time Frame: After 12 weeks of intervention]
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FVC/FEV1
[Time Frame: After 12 weeks of intervention]
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Peak expiratory flow rate (PEFR)
[Time Frame: After 12 weeks of intervention]
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Sit up test
[Time Frame: After 12 weeks of intervention]
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Six Minute Walk test (6MWT)
[Time Frame: After 12 weeks of intervention]
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Secondary ID(s)
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REC/13564 Suman Sheraz
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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