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

Not Applicable

• Conditions: Pregnant Women
• Interventions: Other: Adapted physical activity

• Registration Number: NCT04735146
• Lead Sponsor: First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc

Brief 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.

Detailed 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 ).

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-01-30
• Study First Posted: 2021-02-03
• Study Start: 2021-02-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Adapted physical activity	The Experimental Group will be involved in 1 weekly session of adapted physical activity lasting 1 hour for 6 weeks within the normal cycle of accompanying birth meetings provided by the University Hospital of Bologna.

Primary Outcome Measures

Name	Time	Method
Change in Women's Quality of Life	Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)	12-Item Short-Form Health Survey (SF-12 Questionnaire)

Secondary Outcome Measures

Name	Time	Method
Change in Physical activity levels	Baseline (T1); follow-up after 6 weeks (T2); 3 months after childbirth (T3)	Pregnancy Physical Activity Questionnaire (PPAQ)
Change in Physical Performance	Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)	Six minutes walking distance; Sit to stand test

Trial Locations

Locations (1)

Corso di Laurea in Ostetricia - Scuola di Medicina e Chirurgia Alma Mater Studiorum - Università di Bologna; 🇮🇹 Bologna, Italy