Baseline. Document Number: Number of Pages: Version: 2.2. ities: DCS staff are. 3.0 Responsibil. Not applicable. 5.0 Definitions: strength

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Title: Hand Grip Strength Data Collection Site (DCS) Version Date: 2016-APR-18 Effective Date: 2016-MAY-31 Version: 2.2 Document Number: Number of Pages: SOP_DCS_0028 5 1.0 Purpose: The purpose of this document is to describe the standardizedd proceduree for measuring participants grip strength. 2.0 Scope: This document is to be used by DCS staff to guide the administration of the hand grip strength test to participants. 3.0 Responsibil ities: DCS staff are responsiblee for performing the procedures as described in the current and approved version of the standard operating procedure. 4.0 Related Documents: Not applicable 5.0 Definitions: Dynamometer: a device used to measure hand grip strength 6.0 Equipment: Tracker Freedom Wireless Grip dynamometer 7.0 Supplies: Chair with no arm rests Disinfectant wipe or alcohol wipe 8.0 Procedure Steps: Contraindic ations: Surgery on both hands or wrists within the last 3 months (Contraindications Questionnaire); Pain or paralyses in both hands or wrists due to arthritis, tendinitis, carpal tunnel syndrome (Contraindications Questionnaire); Cast on both arms or hands(contraindications Questionnaire); Open or, sores, wounds or bruising on both hands (Contraindications Questionnaire); Prosthetic arms, hands or fingers on bothh sides (Contraindications Questionnaire). NOTE: Charge the Hand Grip overnight or over a weekend and unplug from the charger at the start of every business day. Do not charge over long periods of Page 1 of 6

time, like during the December break, as this could reduce the overall life of the battery. Important: Positioning/ placement of the participant is critical to ensuree the reproducibility and comparison of this test between visits. Critical steps marked with Step 1: Step 2: Step 3: At the Interview Tab in Onyx, look forr Hand Grip Strength in the list of stages. Then select Start in that row. The Grip Strength: Start window will pop up. Scan the Participant ID barcode, clickk on Continue. Step 4: Step 5: Step 6: Step 7: In Onyx answer Is the dominant hand used for the test by asking the participant to identify his/ /her dominant hand. The dominant hand will be used for the test, unless it is contraindicated. A note will appear in this stage if one hand is contraindicated. Click on the Start button to start the Grip Strength software. In the Grip Strength software, choosee Perform Exam, click CLSA in the three windows, then OK. Choose Instrumented then choose the Handgrip Icon in the top left, click Max Grip and then click on the Play Icon in the left bottom corner. The Device Wake-Up window opens. Unplug the device and press the ON button at the top of the device, see picture below. Step 8: If the device needs to be Zeroed, clickk on Zero, and then OK. To avoid having to do this for each participant, open the Grip Strength (GRI) software in the morning without logging into Onyx and follow Steps 6 to 8. NOTE: Always delete the previous measurementss by clicking the blue Minus icon (Shown below). This cann also be used to delete erroneous tests by highlightingg them and using the minus icon. Page 2 of 6

Minus icon Settings Sequence should read LL or RR Step 9: Be sure the settings are set as shownn above: Units Kilograms Reps 3 Sequence: LL: if the dominant hand is Left. RR: if the dominant hand is Right. Rest Time 15s Threshold 5.0 kg Primary Stat Maximum Normal Type Mathiowetz Step 10: Instruct the participant to assume thee proper position, which is as follows: Sit in a straight-backed chair Feet flat on the floor Arms close to the body and shoulders relaxed Arms unsupported Forearm rotation neutral Elbow flexed at 90-degree with the hand in a neutral position Step 11: Explain the procedure in full and demonstrate the test and the use of the dynamometer to the participant. Handd the dynamometer to the participant (to the dominant hand). Ask the participant to support the device by resting it on thee non-dominant hand, which must be positioned hand open and flat, palm side up, with the battery on the bottom - see picture below. Allow the participant one practice trial before conducting the test. Step 12: Instruct the participant to Squeezee the dynamometer with as much force as possible. Caution the participant to squeeze only once for each measurement. Page 3 of 6

Step 13: Repeat Steps 11-12 two more times, for a total of three trials. Allow a rest period of 15 seconds between trials too avoid muscle fatigue. The result of each trial will be automatically recorded in Onyx. Check mark Step 14: Click the Check Mark in the right topp corner. The conclusionn screen will appear and indicate that you have completed the measurements. Step 15: The software must be closed now by clicking the X in the far right corner of the Grip Strength software. Step 16: In Onyx, presss Refresh, and the three measurements will appear, click Next. Step 17: Click Finish, The Hand Grip Strength: Finish window will pop up. Step 18: Indicate in the comment field in Onyx if there was anything that may have affected or influenced the measurement. Ensure that comments do not contain any personally identifying information. Step 19: Click Continue to return to the statuss page. Step 20: Wipe the handgrip with a disinfectantt or alcohol wipe. 9.0 Documentat tion and Forms: CRF DCS_0028 - Grip Strength Case Report Form 10.0 References: Hand Grip Strength Protocol [revised: 09/03]. Tuffs University Nutrition Collaborative Center for Drug Abuse and AIDS Research (TNC-CDAAR). Available from: http://cdaar.tufts.edu/protocols/handgrip.pdf Page 4 of 6

Timed Walk and Hand Grip Strength Protocol [last updated: 2008 Oct 30]. The Multicenter AIDS Cohort Study (MACS). Available from: http://www.statepi.jhsph.edu/macs/questionnaires/guidelines/v50guide-frailty.pdf Ashton LA, Myers S. Serial grip strength testing Its role in assessment of wrist and hand disability. The Internet Journal of Surgery. 2004; 5(2). Revision History: New Version # Revision Date Revision Author Content Approval 2.2 2016-APR-18 Lorraine Moss Mark Oremus Summary of Revisions Added Disinfectant wipe or alcohol wipe to the list of supplies. Added Step 20: Wipe the handgrip with a disinfectant or alcohol wipe. New Version # Revision Date Revision Author Content Approval 2.1 2014-AUG-20 Lorraine Moss Mark Oremus Summary of Revisions Note added to CI: Important: Positioning/ placement of the participant is critical to the reproducibility and comparison, between visits, for this test. Critical steps marked with Added to Step 4: A note will appear in this stage if one hand is contraindicated. Step 11: Picture added and wording clarified: "Ask the participant to support the device by resting it on the non-dominanwith the battery on the bottom - seee picture below." Removed sentencee in Step 9: You may need to adjust the threshold for a weaker person. The standard grip size is set for the second rung. Added stop signs to list in Step 10 for emphasis. Clarified wording of Scope, Purpose, and Responsibilitiess section. hand, which must be positioned hand open and flat, palm side up, Updated SOP formatting. New Version # Revision Date Revision Author Content Approval 2.0 2013-Jan-16 Lorraine Moss Mark Oremus Summary of Revisions Deleted Validated stopwatch; and from section 5.0 Step 4 re-worded to read Stepp 4 In Onyx answer Is the dominant hand used for the test by asking the participant to identify his/her dominant hand. The dominant hand will be used for the test, unless it is contraindicated. Added Step 5 to section 6.0 Step 6 re-worded to read Step 6 - In the software, choose Perform Exam, Step 7 re-worded to read- The Device Wake-Up window opens. Unplug the device and press the ON button at the top of the device, See picture below. Step 8 re-worded to read - If the device needs to bee Zeroed, click on Zero, and then OK. To avoid having to do this for each participant, open the software in the morning without logging into Onyx and follow steps 6 to 8. Added NOTE Under Step 8 NB:: Always delete the previous measurements by clicking the blue Minus icon (Shown above). This can also be usedd to delete erroneous tests by highlighting them and using the minus icon. Page 5 of 6

Deleted from the end of Step 9 if the participant has a large hand and the grip needs to be moved to the third rung, move the location of the rung prior to measurement. Explain the procedure in full and demonstrate the test and the use of the dynamometer to the participant. Onyx will have identified the dominant hand from the contra-indications questionnaire but to be sure to ask the participant to identify his/her dominant hand. The dominant hand will be used for the test, unless it is contraindicated. If the participant needs to use their non-dominant hand, make a note of this in the comments section. Step 10 revised participant position to lay terms; arms close to the body and shoulders relaxed, elbow flexed at 90-degree with the hand in a neutral position Step 11 re-worded to read Explain the procedure in full and demonstrate the test and the use of the dynamometer to the participant. Hand the dynamometer to the participant (to the dominant hand). Ask the participant to support the device by resting it on the nondominant hand; hand open and flat, palm side up. Allow the participant one practice trial before conducting the test. Step 13 re-worded to read Repeat steps 11-12 for 2 times, for a total of three trials. Allow a rest period of 15 seconds between trials to avoid muscle fatigue Step 14 re-worded to read Click the Check Mark in the right top corner. The conclusion screen will appear indicating that you have completed the measurements. Added note after section 6.0 Added a Sequence comment to picture above step 9. Various grammatical corrections throughout document. SOP_DCS_0028 Page 6 of 6