[Summary text]
RCT
27 randomised, ET+RT=10, ET=10, drop out= 7
8-10 weeks of training (16 exercise sessions)
6MWT, muscle strength
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Control
Overall
Included criteria: The inclusion criteria for the enrollment were as follows: age .50years; former smokers, Tiffenau index (forced expiratory volume in the first second [FEV1]/forced vital capacity [FVC]) ,70% and FEV1 postbronchodi-lator ,80% of predicted value, reversibility of FEV1,12% of basic value and ,200mL of absolute value (30minutes after 400mg salbutamol inhalation), and stable COPD diagnosis.
Excluded criteria: The exclusion criteria were as follows: contrain-dication for physical activity practice; usage of oxygen therapy; evidence of dementia, evaluated by Mini-Mental State Evaluation;15 history of brain injury; history of stroke; history of alcoholism; presence of anxiety and depressive symptoms, evaluated, respectively, by Hamilton Rating Scale for Anxiety16,17 and Beck Depression Inventory;18,19usage of medication influencing cognition; and presence of comorbidity incompatible with the experimental protocol practice.
Pretreatment: The two groups were homogeneous in terms of age, instruction levels, functional status, Medi-cal Research Council Scale scores, severity of the COPD, comorbidities, medications, and cognitive scores
Intervention Characteristics
Intervention 1
Intervention 2
Control
Dropout, n
Muscle strength, SD
Walk test (6-min or SWT), SD
Country: Italy
Setting: Patients from nursing home
Authors name: Giovanna aquino
Institution: Department of Medicine and health sciences “Vincenzo Tiberio”, University of Molise, Campobasso.
Email: giovanna.aquino@unimol.it
Address: Department of Medicine and health sciences “Vincenzo Tiberio”, University of Molise, 86100 Campobasso, Italy
RCT
45 randomised, ET+RT=21, ET=15, drop out=9
12 weeks of training
HRQoL(CRQ), 6MWT, C-P exercise test, muscle strength
Study design: Randomized controlled trial
Study grouping: Crossover
Baseline Characteristics
Intervention 1
Intervention 2
Control
Overall
Included criteria: The eligibility criteria included: forced expiratory volume in one second (FEV1)/forced vital capacity0.7 and FEV155% predicted, age45 years,and currently in stable clinical condition (eg, no exacerbations within two months of enrollment or recent change in medical therapy). Screening procedures included: pulmonary function tests, medical history and physical examination, chest X-ray, resting electrocardiogram, bloodchemistries, hematology and urinalysis.
Excluded criteria:
Pretreatment: There were no significant differences in sample characteristics between the three groups
Intervention Characteristics
Intervention 1
Intervention 2
Control
Quality of life, SD
Dropout, n
ADL, SD
Muscle strength, SD
Walk test (6-min or SWT), SD
Sponsorship source: The source of support for this research was The National Institute of Nursing Research R01-NR10249 and the Department of Veterans Affairs, United States of America. The contents of this paper are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health or the Depart-ment of Veterans Affairs
Country: USA
Comments: ClinicalTrials.gov Identifier: NCT01058213.
Authors name: Margaret K. Covey
Institution: Department of Biobehavioral Health Science, University of Illinois at Chicago, Chicago, IL,United States
Email: mkcovey@uic.edu, margaretcovey@gmail.com
Address: University of Illinois at Chicago, Department of Biobehavioral Health Science, M/C 802, 845 S. Damen Avenue,Chicago, IL 60612, United States.
Outcomes
Dropout: unknown when in the process the patients dropped out (cross over design)Muscle strength: 1RMWalk test: 6-minADL: CHAMPS, activity questionaire for Older adults.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Control
Overall
Included criteria: Patients admitted to chest diseases department, Alexandria Main University Hospital with a primary diagnosis of acute exacerbation of COPD.
Excluded criteria: Exclusion criteria:(1) Hypoxemic patients at rest or exercise.(2) Comorbidity that could limit exercise training like car-diovascular, musculoskeletal or neuromuscular diseases.(3) Patients who attended a pulmonary rehabilitation pro-gram in the preceding year
Pretreatment: No significant differences were found between groupsin terms of age, BMI, airflow obstruction, or arterial bloodgases
Intervention Characteristics
Intervention 1
Intervention 2
Control
Quality of life, SD
Muscle strength, SD
Walk test (6-min or SWT), SD
Country: Eqypt
Setting: Patients admitted to chest disease department at Alexandria Main University Hospital.
Authors name: Rasha Daabis
Institution: Department of Chest Diseases, Faculty of Medicine, Alexandria University, Alexandria, Egypt
Email: rgdaabis@yahoo.com; rgdaabis@gmail.com
Address: Department of Chest Diseases, Faculty of Medicine, Alexandria University, Alazarita, Alkhartoom Square, Egypt
Outcomes
Quality of life: Sct. georges respiratory Questionnaire for COPD SGRQ%Muscle strength: Quadracips strength (1RM, kg)Walk test: 6-min, meter
RCT
51 randomised, total drop out n 13, ET+RT=11, control=13 (RT only=11)
12 weeks of training
Adverse events, HRQoL, 6MWT, muscle strength
part of ET vs RT
RCT
32 randomised, ET+ET+education=11, ET+education=13, 4 drop out in each group
8 weeks of training
HRQoL(CRQ), 6MWT, muscle strength, C-P exercise test
RCT
42 randomised, ET+RT=10, ET=13, drop out=9
12 weeks of training
6MWT, HRQoL(SF 36), C-P exercise test, muscle strength(grip strength?)
RCT
54 randomised, ET=16, ET+RT=14 (RT only=17) 7 dropouts
12 weeks of training
HRQoL, SWT, C-P exercise test, muscle strength
part of RT vs ET
RCT
18 randomised, ET+RT=9, ET=8, drop out=1
12 weeks of training
ADL, 12MWT, muscle strength
RCT
24 randomised, ET+RT=9, ET=10, drop outs=5? only 4 reported
8 weeks of training
Adverse events, 6MWT, muscle strength
RCT
45 randomised, ET+RT=9, ET=11, drop out=17
6 weeks of training
ADL, C-P exercise test
RCT
36 patients with COPD - stable outpatients with COPD
Three arms ET only, ST only or ST and ET, three months
HRQoL, C-P exercise test,
RCT in German
69 COPD patients. Subgroups: with or without supplemental oxygen
ET plus RT and ET alone (and RT alone)
6MWT, C-P exercise test, ADL
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Not described
Quote: "Participants’ randomization into the two groups was per- formed using a random number list, generated using the online software (https://www.random.org/sequences/, Dublin, Ireland). The procedure described was as follows: a progressive number was assigned to each of the participants in alphabetical order according to their surname; a random number list was subsequently generated; and, in accordance with this random number list order, the participants were allo- cated in blocks of two participants per group in the order CT and AT."
Toss of a coin
Quote: "Randomization to group was stratified by gender (strata: male, female) and disease severity (strata: FEV 1 30%e55% predicted, FEV 1 < 30% predicted) with a software program (biased coin algorithm to ensure equivalent groups) [7]."
Quote: "Before being discharged on optimal medical treatment, patients were randomly allo- cated to three groups."
Judgement Comment: Unclear how this was done
Not described
Randomised in blocks of 3-5, method not described
Not described
Not described
Two patients were ascribed to the control group "due to time restraints"
Not described
Not described
not stated
not descriebed
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Not described
Quote: "The procedure described was as follows: a progressive number was assigned to each of the participants in alphabetical order according to their surname; a random number list was subsequently generated; and, in accordance with this random number list order, the participants were allo- cated in blocks of two participants per group in the order CT and AT. After"
Judgement Comment: Unclear if this was an open random allocation schedule
Block randomisation
Judgement Comment: Nothing mentioned
Judgement Comment: Nothing mentioned, no description
Not described
Opaque, sealed envelopes
Not described
Not described
Not described
Not described
Not described
not stated
not descriebed
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Blinding not possible
Nothing mentioned
Blinding not possible
Quote: "patients were not informed of the intent of the three group research design or the expected outcomes of the study."
Judgement Comment: It is unclear if personnel was blinded
Judgement Comment: Nothing mentioned
Blinding not possible
Blinding not possible
Blinding not possible
Blinding not possible
Blinding not possible
Blinding not possible
Blinding not possible
Blinding not possible
not descriebed
Detection bias due to knowledge of the allocated interventions by outcome assessors
Not described
Nothing mentioned
Not described
Quote: "Data collectors were blinded to group assignment and"
Judgement Comment: Nothing mentioned
Not stated
Assessors blinded
Not reported
Not stated
Not described
Not described
Not described
not stated
not descriebed
Attrition bias due to amount, nature or handling of incomplete outcome data
7/20 dropped out, 5 in intervention group versus 2 in control group
No apparent sources of bias
5 patients in intervention group and 4 in control group dropped out, likely unrelated to intervention according to reasons stated.
Judgement Comment: There are the same number of patients who dropped out during training. Yet it is not explained during which type of training the dropout took place (cross-over design)
Judgement Comment: 45 patients were admitted to the study. 30 completed. It is unknown what happened to the remaining 15 patients and in which groups they were allocated.
Almost 1/3 dropped out
Few dropouts, four in each group
Uneven distribution of dropouts
Small dropout rate
One drop out in control group, dropped out due to cancer recurrence
Two drop outs
High drop out rate, 17/45
7 of 43 randomised dropped out, but all due to exacerbations. Not clear from which groups
not descriebed
Reporting bias due to selective outcome reporting
Not detected
No apparent sources of bias
Not detected
Judgement Comment: Matches study protocol
No other apparent sources of bias
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected
VO2 max not reported, though meassured.
none detected
not descriebed
Bias due to problems not covered elsewhere in the table
Not detected
No apparent sources of bias
Uneven sex distribution, 11/4 males/females in contriol grpoup versus 17/4 in intervention group. Also higher BMI in intervention group and higher intensity training, 38/28 Watts
No other apparent sources of bias
No other apparent sources of bias
Not detected
Patients were significantly older in intervention group, 68 versus 74 years.
Not detected
Not detected
Not detected
One patient crossed over from intervention to control group due to low back pain and one was excluded from the control group due to "anomalous change in strength"
Not detected
none detected
not descriebed