Clinical trial NCT02295527: Functional Later Rehabilitation in Older Adults: Effectiveness of Physical Exercises
Official title: Effectiveness of a Physical Exercise Intervention Program in Improving Functional Mobility in Older Adults After Hip Fracture in Later Stage Rehabilitation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hip fractures resulting from falls increase substantially with advancing age and less than a half of the elderly that have sustained and survived after the surgery regain their former levels of mobility. There is increasing evidence that rehabilitation interventions involving exercises and extended beyond the sub acute phase or even in a later stage of care have a positive impact on various functional abilities. The purpose of this study is to determine if an exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care. Randomized controlled trial using blinded assessors and intention-to-treat analysis. We will recruit 82 older adults, 60 years or over who have suffered a hip fracture due to a fall and have or have not completed physiotherapy and/or rehabilitation. These participants will be in a later stage rehabilitation phase (6 months up to 2 years after the fracture). Participants randomized to the Intervention Group (IG) will be submitted to a physical exercise program involving a progressive and challenging balance training and a neuromuscular and functional training of the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour, in the first, second and third month after randomization and will be oriented to perform exercises, twice a week, through a booklet. Visits to follow up exercises progression will be conducted once a month, from de fourth to the sixth month and each two months until the end of the follow up at the 12th month, summing up 18 sessions. Participants will receive monthly phone calls to increase exercise adherence. The control group will receive usual care. The primary outcome will be mobility-related disability and participants will be assessed in the baseline, at the end of the intervention (3 months), at 6 and 12 months. The participants will receive monthly phone calls to investigate falls and exercise adherence. Adverse effects will be monitored.

Detailed description: Over a lifetime, about half of women and a quarter of men will suffer a fragility bone fracture \[1, 2\], mostly due to falling \[2\]. Among the most serious and common fractures are hip fractures, reaching significant levels of mortality \[2\] and disability \[3\]. Hip fracture is an increasingly important problem internationally, particularly in developing countries, due to the growth in the numbers of older people. It is estimated that in 2050 the global number of hip fractures will be between 7.3 and 21.3 million \[4\] and the cost with the treatment will be approximately of 131.5 billion dollars \[5\], due the population increase.

Physical and psychological limitations post-fracture, such as decreased mobility \[6\] and muscle strength of lower limbs \[7\], deficit balance \[6\], lack of trust \[7\], fear of falling \[6\] and increased risk of falls \[8\], hamper around 40% of older people from returning to their daily activities to live independently and safely \[3, 9\]. Even after two years of injury, more than half of the elderly do not regain the functional level prior to injury \[10\], persisting with moderate to high risk of falls \[6\].

Risk of falls and future falls in this population may be due either to physical limitations \[11, 12\] (due to insufficient recovery of balance, muscle strength and consequently mobility) and the fact they have already suffered a fracture previously \[13\], further increasing the chances of new fractures in this population \[14\].

There is no consensus about the best intervention for functionality of the elderly after hip fracture. However, recently different exercise programs have been suggested to improve the mobility of these patients \[8\]. Some studies have shown the effectiveness of rehabilitation programs in the period of up to 6 months after injury \[15-18\]. Although, few studies have explored the late period rehabilitation (over 6 months) \[19, 20\], when functional limitations can persist due to inadequate dose as well as the type of exercise performed. Population in Brazil is growing age in one of the fastest rates in the world and will be even greater in the coming decades. The number of seniors will double between 2002 and 2020, from 15 million to 32 million and reach 64 million by 2050 (about 30% of the total population in Brazil) \[21\]. Furthermore, the elderly aged 80 and over will increase exponentially over the next four decades, putting a growing and disproportionate demand on the health system and social support \[21\].

The purpose of this study is to determine if an exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care.

Eligibility criteria: Inclusion Criteria:

* After the first hip fragility fracture following a fall from standing height or while turning
* Surgically treated in the later stage of rehabilitation phase (6 months up to 2 years after the fracture).

Exclusion Criteria:

* Sustained a hip fracture trauma due to falls from higher surfaces or motor vehicle accidents or due to a tumors or disease (other than osteoporosis)
* Several cognitive impairment, assessed by Mini-Mental State Examination adjusted for educational level \[22\];
* Inability to walk, either with walking aid;
* Progressive or severe neurological disease (e.g., Parkinson's disease, stroke);
* Communication disability (several uncompensated visual or hearing deficits);
* Medical condition contraindications exercise (e.g. unstable angina, severe valvular heart disease, large or expanding aortic aneurysm, etc.) \[23\];
* Engaged in a regular exercise program, with a frequency more or equal than twice a week, 30 minutes a day (excluding walking and senior dance) \[24\].

Primary outcomes:
measure: Lower extremity function (Short Physical Performance Battery (SPPB)
timeFrame: Change from baseline will be assessed at 6 and 12 months
Secondary outcomes:
measure: Physiological risk of falls (Profile Physiological Assessment long version (PPA)
timeFrame: Change from baseline will be assessed at 6 and 12 months
measure: Functional performance (WHO Disability Assessment Schedule (WHODAS II)
timeFrame: Change from baseline will be assessed at 6 and 12 months
measure: Quality of life (WHOQOL-bref)
timeFrame: Change from baseline will be assessed at 6 and 12 months
measure: Physical activity intensity (Planned Exercise Questionnaire - IPEQ_W)
timeFrame: Change from baseline will be assessed at 6 and 12 months
measure: Occurrence of falls
timeFrame: Change from baseline will be assessed at 6 and 12 months
measure: Usual gait speed (evaluate acceleration and deceleration using a stopwatch)
timeFrame: Change from baseline will be assessed at 6 and 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Cidade de São Paulo
state: SP
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Monica R Perracini, Phd
role: PRINCIPAL_INVESTIGATOR
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