[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Patients were Included If they were aged 18 years or older, were able to give informed consent, met the case definition, tolerated compression and were able to perform hel ralses.The case definition for venous ulceration was: any break in the skin on the lower leg that had been present for six weeks or more; no other causative aetiology being present; the ulcer appearing clinically venous, and an ancle brachial Index of more or at 0.8.
Excluded criteria: rheumatold arthritis ar If their general practitioner considered the intervention was contraindicated.
Pretreatment: Excercise Group: 21 people. 5 male and 16 females. Control: 19 people. 8 male and 11 female.
Intervention Characteristics
Intervention
Control
Smerter (Pain) grundet fysisk aktivitet (bivirkning) End of treatment, max 6 mdr.
Ødem End of treatment, max 6 mdr.
Ankelbevægelighed End of treatment, max 6 mdr.
Drop out End of treatment, max 6 mdr.
Funktionsniveau End of treatment, max 6 mdr.
Kondition (evt. 6 min gangtest, trappetest) End of treatment, max 6 mdr.
Livskvalitet End of treatment, max 6 mdr.
Sårheling (prioriteret rækkefølge: total sårheling, sårstørrelse) End of treatment, max 6 mdr.
Tyngdefornemmelse (tunge ben) End of treatment, max 6 mdr.
Sårheling (sårstørrelse) End of treatment, max 6 mdr.
Sponsorship source: The study was funded byt he Health Research Council of NewZealand.ARANZ Medical provided access to a Silhouette Mobile device
Country: New Zealand
Setting: Participants from an existing leg ulcer service. The study intervention could be reproduced at home.
Comments:
Authors name: A Jull, RN,PhD,
Institution: School of nursing and department of General practice and primary care, University of Auckland New Zealand
Email: a.jull@auckland.ac.nz
Address: ?
Stina Kjær on 28/02/2017 21:21
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Jeg er meget i tvivl om dette studie. De måler ikke på ødem, men til gengæld handler det om bensår hvorfor jeg synes det skal med.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Control
Overall
Included criteria: Newly diagnosed with VLU. Never had treatment with compression. Older than 18 years. ABPI 0.8-1.3. Ulcer teween ancle and knee.
Excluded criteria: Diabetes. Pregnant women. And people WHO were unable to give informed consent.
Pretreatment: Age, Ulcer size,
Intervention Characteristics
Intervention
Control
Smerter (Pain) grundet fysisk aktivitet (bivirkning) End of treatment, max 6 mdr.
Ødem End of treatment, max 6 mdr.
Ankelbevægelighed End of treatment, max 6 mdr.
Drop out End of treatment, max 6 mdr.
Funktionsniveau End of treatment, max 6 mdr.
Kondition (evt. 6 min gangtest, trappetest) End of treatment, max 6 mdr.
Livskvalitet End of treatment, max 6 mdr.
Sårheling (prioriteret rækkefølge: total sårheling, sårstørrelse) End of treatment, max 6 mdr.
Tyngdefornemmelse (tunge ben) End of treatment, max 6 mdr.
Sårheling rækkefølge: total sårheling End of treatment, max 6 mdr.
Sponsorship source: No external sources of funding
Country: Ireland
Setting: University Hospital Limerisk. Participants recruited from two community leg ulcer clinics and three vascular outpatient clinics.
Comments:
Authors name: Helen Meagher
Institution: Department of Nursing University Hospital Limerick, Ireland.
Email: helen.meagher@hse.ie
Address: Bioeletronic engineering, national university of Ireland, Galway, Ireland
Wrong intervention
Wrong patient population
Wrong study design
Wrong intervention
Wrong study design
Wrong outcomes
Wrong outcomes
Wrong outcomes
Wrong intervention
Wrong intervention
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Quote: "Committee (WrYIO6/101092) approved the study. <b>Participants were approached through an existing leg ulcer service, and atter consent underwent a baseline assessment, following which the>’ were ran domi>’ allocated to the sttdy using sequentialiy numbered opaque sealed envelopes. Block randomisatlon was used, stratified by the Margolis Index (a prognostic index at ulcer heahng based on ulcer size and durat1on),’ with random numbers generated in Spius.</b> Study treatments The study intervention"
Judgement Comment: Sealed envelopes, but no further desribtion
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: opaque Sealed envelopes
Judgement Comment: Not described,but they have excluded 5 patients after enrollement without desribing how. The patient did not adhere to compression.
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Quote: "themselves onto thelr Uptoes. At baseline, three, slx and nine weeks, the research nurse assessed the maximum number of hed raises, and prescrlbed a regimen of three set5 of repeUUons at 80% at the parilcipant’s maximum."
Judgement Comment: It seems like they are not blinded. It could be unclear instead.
Judgement Comment: Participants not blinded.Unclear when it comes to personnel. But since the participants are doing the intervention at home, there are no personnel besides the ones WHO gives the first information.
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: This is not commented in the article
Judgement Comment: Not desribed
Attrition bias due to amount, nature or handling of incomplete outcome data
Quote: "Ali data analyses were carried mit on an inten tion-to-treat basis."
Judgement Comment: There are also reported why two participants where excluded.
Judgement Comment: Two participant failed to record their steps on week 12. What did they do with the data?
Reporting bias due to selective outcome reporting
Quote: "Northem Regional Ethics Committee (WrYIO6/101092) approved the study."
Judgement Comment: There must be a protocol when the study has been approved.There is no primary outcome, which is due to this being a pilot study. A bit strange!Ulcer healing is said to be outcome only reported in the text. Not possible to do meta-analysis.
Judgement Comment: The independent variable measured in this study was the number of steps taken by each participants. But they want to conclude is excersice can better ulcer healing? Ulcer healing reported as numbers in the text. Not suiteble for meta-analysis.
Bias due to problems not covered elsewhere in the table
Judgement Comment: Not enough power to do the analysis. Risk of type 2 error.
Judgement Comment: The participants did not reach the number of steps as they should. So they can´t really concluded since the participants didn't do the intervention.Baseline imbalance according to age.