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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04735146
Acronym
WELL-DONE!
Enrollment
150
Registered
2021-02-03
Start date
2021-02-20
Completion date
2022-06-30
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women

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 ).

Interventions

OTHERAdapted 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.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Women's Quality of LifeBaseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)12-Item Short-Form Health Survey (SF-12 Questionnaire)

Secondary

MeasureTime frameDescription
Change in Physical activity levelsBaseline (T1); follow-up after 6 weeks (T2); 3 months after childbirth (T3)Pregnancy Physical Activity Questionnaire (PPAQ)
Change in Physical PerformanceBaseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)Six minutes walking distance; Sit to stand test

Countries

Italy

Contacts

Primary ContactDila Parma
facmed.cdlostetricia@unibo.it+39 3313571212

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026