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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05985616
Other study ID # REC01549 Shanza Nisar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2023
Est. completion date January 19, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Studies conducted so far added the dietary supplements along with resistance training as an intervention, we could not determine whether the observed effects of the intervention were due to the training program and/or dietary supplements.


Description:

This study will investigate the effects of high intensity resistance training solely in the possible sarcopenia cases which has not done before, to author's knowledge. Furthermore this study will help clinicians to individualize and optimize the therapy for specific patient subgroups, improve the potential of this therapy to improve human function and well being, facilitate timely interventions in community healthcare and prevention settings, which will contribute to higher awareness of sarcopenia prevention and interventions in diverse health care settings.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date January 19, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Both male and female - Age more than 60 years - Possible sarcopenia cases as defined by Asian Working Group for Sarcopenia (Handgrip strength: Male less than 26kg and Female less than 18kg, 5 time chair stand test more than/equals to 12 seconds) Exclusion Criteria: - Orthopedic surgery in last one year - Neurological disorders like stroke etc - History of recent fractures - Metabolic disorders like DM etc - Actively involved in exercise programs - Cognitive impairment that could confound the assessment - Wheelchair or bed bound individuals

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High Intensity Resistance Training
High intensity resistance training will be performed 3 times a day for sixteen weeks

Locations

Country Name City State
Pakistan Abbas Institute of Medical Sciences Muzaffarabad Azad Kashmir

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Abdul-Hameed U, Rangra P, Shareef MY, Hussain ME. Reliability of 1-repetition maximum estimation for upper and lower body muscular strength measurement in untrained middle aged type 2 diabetic patients. Asian J Sports Med. 2012 Dec;3(4):267-73. doi: 10.5812/asjsm.34549. — View Citation

Kemmler W, Kohl M, Frohlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28. — View Citation

Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hand Dynamometer it used to measure the hand grip strength. the test-retest reliability is 0.91 and 0.95 with excellent reliability. The assessment will be made at baseline, week 8 and 16 16 weeks
Primary Short performance physical battery an objective assessment tool for evaluating lower extremity functioning in older persons. the test-retest reliability is 0.87. It was used to measure at baseline, week 8 and 16 16 Week
Secondary FRAIL The questionnaire aims at fatigue, resistance, ambulation, illness and loss of weight. It is a self reported questionnaire. The sensitivity of FRAIL is 85.8% and a specificity of 80.6%.
The test will be measured at baseline, week 8 and 16
16 week
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