The Effect Water-exercise on Low Back Pain and Sick Leave, Among Healthy Pregnant Women

NCT02354430 | Completed

• 1 other identifier: 7-12-1088
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the possible effect of an unsupervised water-exercise program, on the intensity of low back pain and the number of days spent on sick leave, among healthy pregnant women Our hypothesis is, that 45 minutes of water exercise twice a week for a period of 12 weeks during pregnancy, will reduce the intensity of low back pain and the days spent on sick leave.

Conditions

Low Back Pain

Keywords

pregnancy; low back pain; sick leave,; motor activity

Outcome Measures

Primary Outcomes (1)

• Low back pain Rating Scale

  three numeric 11 point box scales (pain now, worst pain in the past two weeks, average pain in the past two weeks), 0 indicating no pain to 10 indicating worst pain imaginable.

  At 12 weeks, after initiating the exercise-program

Secondary Outcomes (1)

• Sick leave (Number of days spend on leak leave, due to pregnancy-related complications, sickness with no relation to the pregnancy, or due to the work environment)

  At 12 weeks, after initiating the exercise-program

Other Outcomes (2)

• Roland Morris Disability Questionnaire

  At 12 weeks, after initiating the exercise-program

• EQ-5D-3L

  At 12 weeks, after initiating the exercise-program

Study Arms (2)

Water-exercise

ACTIVE COMPARATOR

Behavioral: Water-exercise

Control group

NO INTERVENTION

Interventions

Water-exercise BEHAVIORAL

1. An instruction session at an indoor swimming pool, led by the research midwives and a specially trained coach. Participants is shown short movie clips of the six Aqua-Mama water-exercises and practical instructions by the coach while performing the exercises in water. The participants are encouraged to keep a training logbook during the project. 2. One training session consists of: eight laps (200 m) of swimming and AquaMama exercises. Each exercise is illustrated on a board and are performed twice 3. Unsupervised water-exercises (The six AquaMama exercises) 4. Motivating weekly emails during the 12 week training period. 5. Brush up sessions is held once every month for guidance in performing the exercises.

Water-exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, pregnant women giving birth at Rigshospitalet, Copenhagen
• With a single foetus.
• Gestational weeks 16-17.

You may not qualify if:

• Medical or obstetrical conditions contraindicating physical activity.
• Women who are diagnosed in the present pregnancy or have formerly been diagnosed with pelvic girdle syndrome.
• BMI \> 29 kg/m2.
• Non-Danish speaking.
• Women with substance abuse problems.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Obstetrics, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Backhausen MG, Tabor A, Albert H, Rosthoj S, Damm P, Hegaard HK. The effects of an unsupervised water exercise program on low back pain and sick leave among healthy pregnant women - A randomised controlled trial. PLoS One. 2017 Sep 6;12(9):e0182114. doi: 10.1371/journal.pone.0182114. eCollection 2017.

  PMID: 28877165 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Hanne Kristine Hegaard, Ph.D

  Department of Obstetrics, The Juliane Marie Centre for Women, Children and Reproduction, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9 DK-2100 Copenhagen Ø, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 3, 2015
• Study Start: December 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 2, 2016

Record last verified: 2016-09

Locations

DK (1)