Aim: The present study aimed to determine the effect of a cycle of aerobic exercise on mother and neonate outcomes.
Method and design: This study was a single blind randomized controlled clinical trial, in which patients did not know about their allocation to the study groups and they also did not have access to the other.Sampling method was simple sampling.
Subjectives, Inclusion and exclusion criteria: 34 lactating,
referring to breast feeding clinic, Isfahan, Iran in 2015-2016 were randomly divided into the intervention and control groups. Inclusion criteria include: non-athletic lactating mothers who feed their baby Exclusively with their milk; 6-8 weeks after delivery; the term infant; the Mother has no activity during the last three months.
Major exclusion criteria include: mothers using psychiatric drugs; cigarette; supplementary infant; women with preterm labor. Intervention group subjects were required to do aerobic exercises for six weeks (three days in week for thirty minutes in day). However, mothers in the control group only received the routine care. The main outcome variables in this study were lactation intervals in 24 hours and the weight of newborns, which were measured by lactation questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071435078N1
Registration date:2017-09-17, 1396/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-17, 1396/06/26
Registrant information
Name
Akram Amini
Name of organization / entity
Yasuj university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 913 289 9533
Email address
amini@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj university of medical science
Expected recruitment start date
2016-02-23, 1394/12/04
Expected recruitment end date
2017-02-24, 1395/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Breast feeding optimal and neonate's growth after mother aerobic exercise: a randomized controlled clinical trial
Public title
The effect of exercise on lactating
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include: non-athletic lactating mothers who feed their baby exclusively with their milk; 6-8 weeks after delivery; the term infant; the Mother has no activity during the last three months.
Major exclusion criteria include: mothers using psychiatric drugs; cigarette; Supplementary infant; women with preterm labor.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The one-way blind method was that the research units did not know their allocation to the study groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yasuj university of medical science؛ ethic commitee
Street address
Motahari st, Yasuj University of Medical Scienc, Yasuj
City
Yasuj
Postal code
Approval date
2013-11-17, 1392/08/26
Ethics committee reference number
Yums.rec.1391.01
Health conditions studied
1
Description of health condition studied
lactation
ICD-10 code
z39.1
ICD-10 code description
Care and examination of lactating mother
Primary outcomes
1
Description
Neonate weight
Timepoint
At the start of the study and after intervention
Method of measurement
lactation status questionaire using the interviwe
2
Description
Breast feeding frequency
Timepoint
At the start of the study and after intervention
Method of measurement
lactation status questionaire using the interviwe
Secondary outcomes
empty
Intervention groups
1
Description
Training of aerobic exercise under the supervision of expert then performed. An educational pamphlet of the exercises along with the CD gives them. Those in the exercise group undertook a program of aerobic exercise lasting 30 minutes per day, 3 days per week, for 6 weeks beginning 6 to 8 weeks post partum. The movements of aerobic exercise in each session include a three-step including warm-up, workout and cool down.Three or more days of exercise in any week, an extra week was added to the program. The researcher telephoned the participants to remind them of the timing of the interventions and follow-up.
Category
Other
2
Description
Mothers in the control group only received the routine care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital, breast feeding clinic
Full name of responsible person
Akram Amini
Street address
Sofeh st, Alzahra hospital, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Yasuj University of Medical Sciences
Full name of responsible person
Dr Hossein Mari Oryad
Street address
Motahari st, Yasuj University of Medical Scienc, Yasuj
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yasuj university of medical science
Full name of responsible person
Akram Amini
Position
Master of nursing
Other areas of specialty/work
Street address
Sofeh st, Alzahra hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 4232 2782
Fax
Email
rahaamini409@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj university of medical science
Full name of responsible person
Akram Amini
Position
Master of nursing
Other areas of specialty/work
Street address
Sofeh st, Alzahra hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 4232 2782
Fax
Email
rahaamini409@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj university of medical science
Full name of responsible person
Akram Amini
Position
Master of nursing
Other areas of specialty/work
Street address
Sofeh st, Alzahra hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 4232 2782
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)