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ProBalance Project - Prehabilitation and Rehabilitation Nursing: Balance/ fall risk in the community-dwelling older adults PILOT STUDY

Prehabilitation and Rehabilitation Nursing: Balance/ fall risk in the community-dwelling older adults - Randomized Controlled Trial PILOT STUDY

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001164987
Acronym
ProBalance
Enrollment
12
Registered
2011-11-08
Start date
2015-11-09
Completion date
2015-11-20
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This project incorporates a pilot study of a larger scale randomized controlled trial aimed to: (1) Investigate of the effect of a gerontological rehabilitation nursing program in a group of community-dwelling elderly, living in Madeira, Portugal, on balance (FAB Scale scores), muscular strength (30 second chair stand, arm curl), functional mobility (8 Foot Up and Go), gait parameters (30-foot walk), health related quality of life (SF-36 - Portuguese version, Ribeiro (2005)), fear of falling (FES – Portuguese version, Melo (2011)), home environment (based on Lord, Sherrington, Menz & Close; 2007), and number of falls (number of fallers and falls rate), when compared to a control group. (2) Describe the relationship between potential confounders and balance/incidence of falls in older adults involved in the rehabilitation program, when compared to a control group. This research is based on three hypotheses: (1) A rehabilitation nursing program designed to approach balance and mobility, as well as multiple risk factors, can reduce the risk of falling in a group of older-adults, when compared to the control group, after a 3 month duration intervention and during follow up; (2) A rehabilitation nursing program designed to approach balance and mobility, as well as multiple risk factors, can improve balance in a group of older-adults, when compared to the control group, after a 3 month duration intervention and during follow up; and (3) The group of older-adults involved in a specific rehabilitation program present higher levels of balance/lower risk for falling, higher levels of strength and functional mobility, better results in gait parameters, higher levels of health related quality of life (SF-36 - Portuguese version, Ribeiro (2005)), reduced fear of falling (FES – Portuguese version, Melo (2011)), and less risk factors in home environment, when compared with the older-adults included in the control group, after a 3 month intervention and 6 month follow up. The pilot study consists in a "mini-RCT", with one month duration and a sample of 20 participants, aimed at testing procedures, and estimating recruitment, retention and sample size for the larger RCT.

Interventions

Following the preliminary evaluation, the experimental group will receive a multidimensional rehabilitation nursing intervention. Intervention includes a multiple risk approach, namely, an exercice program (tailored for older adults with moderate risk for falling) and an educational component addressing fall prevention and home hazards at the beginning of the intervention period. Rehabilitation sessions will have 1 hour duration, 3 days per week, during 4 weeks. It will include: (1) multisensor

Following the preliminary evaluation, the experimental group will receive a multidimensional rehabilitation nursing intervention. Intervention includes a multiple risk approach, namely, an exercice program (tailored for older adults with moderate risk for falling) and an educational component addressing fall prevention and home hazards at the beginning of the intervention period. Rehabilitation sessions will have 1 hour duration, 3 days per week, during 4 weeks. It will include: (1) multisensory training (approaching visual, somatosensory and vestibular systems); (2) center of gravity control Training; (3) proactive and reactive postural strategy training; (4) gait pattern enhancement and variation training; and (5) strengthing and flexibility training. The intervention will be administered on a group basis by one trained rehabilitation specialist nurse.

Sponsors

Bruna Raquel Gouveia
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Community-dwelling older adults; Report at least one fall in the last year, or no falls, if FAB score equal or lower than 30/40; Able to walk independently.

Exclusion criteria

Cognitive impairment (assessed by the MMST) Significant co-morbidities that would preclude participation (acute illness, progressive neurological disease, stroke, unstable chronic conditions, etc.)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026