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High Intensity Resistance Training and Possible Sarcopenia

Primary Purpose

Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity Resistance Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group A

    Group B

    Arm Description

    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.

    No intervention will be provided in this group. The participants in this group will follow their usual daily activities.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    August 3, 2023
    Last Updated
    August 3, 2023
    Sponsor
    Riphah International University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05985616
    Brief Title
    High Intensity Resistance Training and Possible Sarcopenia
    Official Title
    Effects of High Intensity Resistance Training on Physical Function in Possible Sarcopenia Cases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Riphah International University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group B
    Arm Type
    No Intervention
    Arm Description
    No intervention will be provided in this group. The participants in this group will follow their usual daily activities.
    Intervention Type
    Other
    Intervention Name(s)
    High Intensity Resistance Training
    Intervention Description
    High intensity resistance training will be performed 3 times a day for sixteen weeks
    Primary Outcome Measure Information:
    Title
    Hand Dynamometer
    Description
    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
    Time Frame
    16 weeks
    Title
    Short performance physical battery
    Description
    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
    Time Frame
    16 Week
    Secondary Outcome Measure Information:
    Title
    FRAIL
    Description
    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
    Time Frame
    16 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shanza Nisar, DPT
    Phone
    0092 342 5744870
    Email
    shanzahnisar@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mirza Obaid Baig, MSPT
    Phone
    00923332238706
    Email
    obaid.baig@riphah.edu.pk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mirza Obaid Baig, MSPT
    Organizational Affiliation
    Riphah International University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32270891
    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.
    Results Reference
    background
    PubMed Identifier
    24864078
    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.
    Results Reference
    background
    PubMed Identifier
    23342225
    Citation
    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.
    Results Reference
    background

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    High Intensity Resistance Training and Possible Sarcopenia

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