Adapted Physical Activity to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women (WELL-DONE!Study)

Pregnant Women Clinical Trial

— WELL-DONE!  

Official title:

Co-design and Evaluation of the Feasibility and the Efficacy of a Multiple-targeted Adapted Physical Activity Intervention to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women: the WELL-DONE! Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735146
• Other study ID #: 984/2020/Sper/AOUBo
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2021
• Source: First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc
• Contact: Dila Parma
• Phone: +39 3313571212
• Email: facmed.cdlostetricia[@]unibo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the WELL-DONE! Study is to co-design, using different professional figures (midwives, psychologists, master's degree in motor science) but also taking into consideration the pregnant women's point of view, an intervention of adapted physical activity for pregnant women, included in the birth accompaniment courses and conducted by midwives, and to evaluate its effectiveness in terms of quality of life, well-being, levels of physical activity and satisfaction with respect to the proposed intervention.

Description:

The primary objective is the evaluation of an integrated, co-designed intervention of adapted physical activity, included in the birth accompaniment courses, in order to improve the quality of life of pregnant women.

• The secondary objective is the evaluation of the feasibility, efficacy and safety of the intervention in terms of general satisfaction with the proposed intervention, levels of physical activity practiced, physical performance, self-efficacy, sleep quality, anxiety and depression.

• The tertiary objective is to translate, adapt and validate in Italian a specific questionnaire to measure physical activity levels in pregnant women, Pregnancy Physical Activity Questionnaire (PPAQ), through the use of Actigraph accelerometers (ActiLife6 wGT3X-BT ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women between the 24th and 32th week.

• Pregnant women belonging to the birth accompaniment meetings organized by University Hospital of Bologna

Exclusion Criteria:

• Alterations in communication skills and / or sensory functions so severe as to make it impossible to understand and / or execute the instructions given by the trainer (dementia, aphasia, blindness, deafness);

• Premature Rupture of Membranes (PROM).

• Premature labor.

• Vaginal bleeding.

• Placenta previa after 28 weeks gestation.

• Pre-eclampsia

• Cervical incontinence

• Intrauterine fetal growth delay or arrest.

• Plurigemellarità

• Uncontrolled type I diabetes.

• Uncontrolled hypertension.

• Uncontrolled thyroid disease.

• Other severe cardiovascular, respiratory or systemic disorders.

• Any other condition the operator deems may contraindicate participation in a moderate intensity exercise program.

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Other:
• Adapted physical activity
Participants in the experimental group will undergo the adapted physical activity program that will be co-designed during phase I of the study. The 6-week program is aimed at improving the quality of life; increase the physical activity levels according to recommended guidelines; improving body awareness through an educational component; maintain and ameliorate the previous functions (for women previously active) and build the exercise background for sedentary women; increase physical fitness and functional capacity.

Locations

Country	Name	City	State
Italy	Corso di Laurea in Ostetricia - Scuola di Medicina e Chirurgia Alma Mater Studiorum - Università di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Women's Quality of Life	12-Item Short-Form Health Survey (SF-12 Questionnaire)	Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
Secondary	Change in Physical activity levels	Pregnancy Physical Activity Questionnaire (PPAQ)	Baseline (T1); follow-up after 6 weeks (T2); 3 months after childbirth (T3)
Secondary	Change in Physical Performance	Six minutes walking distance; Sit to stand test	Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)