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

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

Status: Unknown

Conditions: Pregnant Women

Treatments: Other: Adapted physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT04735146

984/2020/Sper/AOUBo

Details and patient eligibility

About

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.

Full 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 ).

Enrollment: 150 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Other: Adapted physical activity

Control Group

No Intervention group

Description:

The control group is expected to participate in 6 birth accompaniment meetings held online, 1 hour of which will be dedicated to the topic of exercise and physical activity recommendations in pregnancy.