Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201807133014659 Date of Approval: 13/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Balance training; its influence on pulmonary rehabilitation
Official scientific title Balance training and pulmonary rehabilitation
Brief summary describing the background and objectives of the trial Background: Risk of falls is one of the most complications for patients with chronic obstructive pulmonary disease (COPD). Objective: To investigate the value of adding balance training to pulmonary rehabilitation program in COPD patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 05/06/2017
Actual trial start date 12/06/2017
Anticipated date of last follow up 15/03/2018
Actual Last follow-up date 14/04/2018
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group balance training and pulmonary rehabilitation program 25–30 min (total session). Frequency: 3 times/week (day after day). Eight weeks (1) functional strength exercise (e.g. heel raise, toe raise, walking on toes, step ups in all directions [forward, backward and sideway], squats, core strength on ball) with arm support then without arm support (each exercise 2 sets 8 times each). (2) stance exercise (e.g. tandem, narrow, one leg stance and stand on uneven surfaces) with open eyes (each exercise 30 seconds) then with eyes closed (each exercise 15 seconds). (3) transition exercise (e.g. sit to stand from chair with arms [10 repetitions] then without arms support [5 repetitions], sit on floor and stand up with assistance and then without assistance. (4) gait training (e.g. walking tandem, sideway and backward with arm support and without arm support, walking over obstacles). In addition to balance exercises, the pulmonary rehabilitation program is a key part of exercise training for Group A, that is consist of (1) individualized endurance exercise training based on 60-80% of 6 minutes walking test speed achieved. (2) strength exercise for large muscle groups in upper and lower extremities using Thera band and weights (3 sets 8 repetition each with rest between sets about 1.30 minute). Workload based on 50-75% of 1 RM, which repeated at week 4. (3) daily breathing exercises (e.g. diaphragmatic, pursed lip breathing and stretch exercise for major respiratory muscles). 24
Control Group pulmonary rehabilitation program only. 25–30 min (total session). Frequency: 3 times/week (day after day). Eight weeks (1) individualized endurance exercise training based on 60-80% of 6 minutes walking test speed achieved. (2) strength exercise for large muscle groups in upper and lower extremities using Thera band and weights (3 sets 8 repetition each with rest between sets about 1.30 minute). Workload based on 50-75% of 1 RM, which repeated at week 4. (3) daily breathing exercises (e.g. diaphragmatic, pursed lip breathing and stretch exercise for major respiratory muscles). 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
moderate to severe COPD (FEV1/FVC < 70% predicted and FEV1 < 80% predicted) according to physician diagnosis, smoking history of more than 10 packs/year, age between 60 to 65 years, good cognition level fall history in the last five years. Very severe COPD (FEV1 < 50% predicted), Oxygen dependent or mechanically ventilated patients, decrease cognition level, limited balance and mobility due musculoskeletal or neurological condition. Presence of visual or hearing disorders. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 61 Year(s) 65 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 16/07/2018 Research Ethics committee faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
Ahmed El zayat St. Giza 12624 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome In the treatment of the patients with the pulmonary rehabilitation program, there was an improvement in their ability to maintain balance according to the results. After the period of 8 weeks of pulmonary rehabilitation program
Secondary Outcome It was noted that there was a significant improvement in the maintenance of balance and reduce fall risk in COPD patients who undergo the pulmonary rehabilitation program in addition to balance exercises. At the end of a period of 8 weeks ob balance training and pulmonary rehabilitation program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wadi El Neel hospital Wadi El Neel St. Cairo 11668 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wadi El Neel Hospital Wadi El Neel St. Cairo 11766 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Mounir khaledassem67@hotmail.com +201222229777 Yousef Abbas
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Egyptian Chinese University
Role Name Email Phone Street address
Public Enquiries Noha Elserty noha_elserty@hotmail.com +201006709648 Shoubra St.
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Egyptian Chinese University
Role Name Email Phone Street address
Scientific Enquiries Hany Obaya hany_obaya@yahoo.com +201001746517 Maadi St.
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information