Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201805003348323 Date of Approval: 25/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Exercise and Insomnia in Elderly people
Official scientific title Effect of aerobic exercises on sleep and hormonal levels in elderly with chronic primary insomnia
Brief summary describing the background and objectives of the trial Sleep complains are highly prevalent in elderly population, with insomnia being the most prevalent. Untreated insomnia has major consequences. Pharmacologic treatment have been proposed in the literature but it is associated with many problems. Exercise is one of non pharmacologic therapy alternative that showed its efficacy, however more researches are needed to the relationship between exercise and sleep focusing on the roles of levels of some hormones. The trial assessed the efficacy of aerobic exercises on Pittsburg sleep quality index, serotonin, epinephrine and norepinephrine levels in elderly with chronic primary insomnia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied primary insomnia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/06/2017
Actual trial start date 01/02/2018
Anticipated date of last follow up 03/12/2017
Actual Last follow-up date 01/02/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Stopped early/ terminated
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 randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group exercise 1 hour/day 3 times/week for three months, The aerobic exercise program in the form of walking on treadmill. 20
Control Group control group no dose assessment was done before and after 3 monthes this group not receive any form of exercise 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) the age ranged between 60-70 years old; 2) clinical diagnosis of primary insomnia; 3) history of insomnia complaints > 6 months; 4) presence of at least one complaint of daytime impairment resulting from insomnia (including mood, cognition, or perception of fatigue)2). Pittsburgh Sleep Quality Index Score ¿ 5 1) insomnia secondary to medical conditions or medications 2) current participation in regular exercise; 3) unstable medical conditions; 4) contraindications to exercise training (e.g., physical limitations) ; 5) psychiatric disorders; 5); major cognitive impairment Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 75 Year(s) Both
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
Yes 01/10/2017 faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
hussin Elzayate Giza 11111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pittsburg sleep quality index before and after 3 months of exercise
Secondary Outcome serotonin, epinephrine and norepinephrine levels before and after 3 months of exercise
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hedia Barakat nursing home 23 Abokaker Elsedik, Dokky Giza 12611 Egypt
Faculty of physical therapy Hussin Elzayat Giza 11111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical therapy Hussin Elzayat Giza 11111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Hussin Elzayat Giza 11111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faculty of physical therapy Hussin Elzayat Giza 11111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Basant H El-Refaey basanthamndy@yahoo.com +201001224979 Hussien Elzayat Street
City Postal code Country Position/Affiliation
Giza 1111 Egypt Asst Prof Dept Physical Ther Cardiovasc/Respiratory Disord. Faculty Physical Therapy Cairo Univ
Role Name Email Phone Street address
Public Enquiries Hend El-Wakel Dr_physiology_dep@yahoo.com +201065216930 23 Faried Nada Street
City Postal code Country Position/Affiliation
Banha 13518 Egypt Lecturer Dept Physiology, Faculty Medicine, Banha Univ, Egypt
Role Name Email Phone Street address
Scientific Enquiries Olfat Ibrahim Ali olfat_ib@yahoo.com 201001248426 Hussien Elzayat Street
City Postal code Country Position/Affiliation
Giza 1111 Egypt Asst Prof Dept Basic Sci Physical Therapy. Physical Therapy Faculty. Univ Cairo
REPORTING
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