- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05985616
High Intensity Resistance Training and Possible Sarcopenia
Effects of High Intensity Resistance Training on Physical Function in Possible Sarcopenia Cases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Azad Kashmir
-
Muzaffarābād, Azad Kashmir, Pakistan
- Abbas Institute of Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
High intensity (80-85% of 1RM) will be administered at alternative days for 16 weeks. The exercise will have three phases; Phase I consists of 2-3 sets of 8-15 repetitions, Phase II will follow the single set approach and Phase III will have the Superset approach. The following activities will be incorporated via resistance training: latissimus front pulleys, rowing, back extension, inverse fly, bench press, shoulder press, lateral raises, butterfly with extended arms, crunches, leg presses, leg extension and curls, leg adduction, abduction. |
High intensity resistance training will be performed 3 times a day for sixteen weeks
|
|
No Intervention: Group B
No intervention will be provided in this group.
The participants in this group will follow their usual daily activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Dynamometer
Time Frame: 16 weeks
|
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
|
|
Short performance physical battery
Time Frame: 16 Week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FRAIL
Time Frame: 16 week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC01549 Shanza Nisar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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