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Iliffe S, Kendrick D, Morris R, et al. Multicentre cluster randomised trial comparing a community group exercise programme and home-based exercise with usual care for people aged 65 years and over in primary care. Southampton (UK): NIHR Journals Library; 2014 Aug. (Health Technology Assessment, No. 18.49.)

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Multicentre cluster randomised trial comparing a community group exercise programme and home-based exercise with usual care for people aged 65 years and over in primary care.

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Appendix 3Adverse reactions (from Chapter 5)

Description of all ARs (i.e. events related to the trial) occurring during the ProAct65+ trial.

Falls Management Exercise programme adverse reactions

‘High knee standing’ exercises made patient’s lower-back ache.

Aching pain in calf.

Cold pain in stomach and bad taste in mouth, started after first FaME class. Patient said she would see her GP.

Patient called to say the FaME exercises ‘upset his metabolism’.

Patient feels soreness in muscles and joints.

Patient fell in FaME class, no injuries, potentially as a result of adjusting to new glasses.

Potentially pulled back muscle after doing sit down weights at gym.

Pulled calf muscle while doing our home exercise session ex 3. Sore for 2 days but did not affect normal activities.

Was out power walking and pulled a muscle; did not seek medical attention; rested and massaged leg.

Fell when in FaME class, taken to A&E, let go and in evening said was OK.

Pulled muscle.

Plantar fasciitis started about a year ago and has been getting worse, (first had it 20 years ago), got worse when started doing more walking to improve health. Recently visited podiatrist/foot surgeon (private) for a cortisone injection into left heel.

Pulled muscle.

Knee pains so didn’t attended classes.

Otage Exercise Programme adverse reactions

History of intermittent knee pains past 2 years assumed osteoarthritis – no medical diagnosis. November 2011, aches in knees. Stopped leg weights exercise. Started again January 2012 and again experienced pain in knees. Still does other exercise tai chi and keep-fit class.

Began to have more back pain from approximately March 2011. Doing our home exercise made it worse. Saw podiatrist then GP who diagnosed Sciatica. Given painkillers. Pain has been on and off for several years.

Burst blood vessel in leg after using Otago weights.

Hurt left wrist/fingertips after using Otago weights to strengthen arms. Ointment prescribed, wrists/fingertips recovered.

Pain in small of back after Otago training.

Plantar fasciitis – started after Otago exercises.

Potentially pulled ligament in right knee.

Patient reported in diary that they had slight hip problem; during follow-up telephone call patient stated that ‘walking backwards during home exercises’ had aggravated hip; OK now stopped exercises.

Patient withdrew from study exercises because of pains in right hip exacerbated by exercise; has sciatic pain – intermittent and ongoing. Also commented in OEP evaluation forms of general health decline and hip and sciatica problems.

Suspected pulled muscle in right foot after Otago training.

Swelling of varicose vein on right leg after using leg weights. Also commented on OEP evaluation forms.

While walking a lot on holiday patient hurt back, patient puts it down to a disc problem in the past and will rest it, will not see the doctor as it is a reoccurrence and just needs rest.

Decided to cycle not walk for exercise. Went up hill and got a hernia. About to go in for operation.

Keyhole surgery on knee.

Left knee/groin pain after doing ankle exercises with weights.

Pain in leg from exercises.

Pulled knee ligaments when doing exercises with weight. Right knee, recently replaced. Saw GP about it. No long-term damage. Is continuing without weights.

Pulled muscle in back.

Pulled muscle in leg after exercising.

Bad knees for years. Advised to see GP.

Hip pain diagnosed with arthritis, patient thinks caused by weights exercise.

Left knee pain after exercises with 2-kg weights on.

Pain behind knee – better now after stopping exercising with weights.

Pain when walking, thinks as a result of OEP training and her existing osteoarthritis.

Sciatic worsened after OEP training.

Sciatica worsened.

Usual-care adverse reactions

Pain in shoulder while using ‘shake weight’.

Worsened pain in knees and lower back. X-ray came back fine; patient said her knees and back were starting to feel better.

Copyright © Queen’s Printer and Controller of HMSO 2014. This work was produced by Iliffe et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK262326

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