Functional Later Rehabilitation in Older Adults: Effectiveness of Physical Exercises

NCT02295527 | Unknown DMC

• 1 other identifier: CAAE: 27398814.7.0000.0064
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Lower extremity function (Short Physical Performance Battery (SPPB)

  will be measured by theSPPB \[27\], that consists of three blocks of tests that assess static balance, walking speed and, indirectly, the strength of the lower limbs (sitting and standing from a chair unassisted). Each test has a score of zero (worst performance) to 4 points (best performance), summing a total final score of 12 points. Change from baseline will be assessed at 6 and 12 months.

  Change from baseline will be assessed at 6 and 12 months

Secondary Outcomes (6)

• Physiological risk of falls (Profile Physiological Assessment long version (PPA)

  Change from baseline will be assessed at 6 and 12 months

• Functional performance (WHO Disability Assessment Schedule (WHODAS II)

  Change from baseline will be assessed at 6 and 12 months

• Quality of life (WHOQOL-bref)

  Change from baseline will be assessed at 6 and 12 months

• Physical activity intensity (Planned Exercise Questionnaire - IPEQ_W)

  Change from baseline will be assessed at 6 and 12 months

• Occurrence of falls

  Change from baseline will be assessed at 6 and 12 months

Study Arms (2)

Home-based physical exercise

EXPERIMENTAL

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.

Other: Home-based physical exercise intervention

Control Group Usual Care

OTHER

This group will receive usual care and the booklet regarding bone health information.

Other: Control Group Usual Care

Interventions

Home-based physical exercise intervention OTHER

Progressive strengthening of muscle groups ankle dorsi flexors, knee extensors and hip abductors and progressive balance training according to individual capacity:weight-bearing, limits of stability, change of position/direction, maintenance of static and dynamic stability, anticipatory adjustments using different bases of support and different sensory conditions. Dynamic exercises involving spin on its own axis, sitting and standing, up and down stairs, functional reach, steps in different directions and walk training. In the first session the physiotherapist will choose two exercises that best address the participant function goals and will add more exercises each week according to the level of participants' ability and motivation. Participants will receive a detailed booklet, containing photos and instructions of the12 exercises.Visits to follow up exercises will be conducted by the physiotherapists to progress the exercises.

Also known as: REATIVE

Home-based physical exercise

Control Group Usual Care OTHER

This group will receive usual care and will not have any disadvantage in participating in the study. We understand that usual care is what participant receives based on the network of health care in which he/she is inserted. The participants will receive at baseline assessment a diary falls logbook and a guidance booklet containing information about prevention of falls, fractures and bone health that will be explained at the moment.

Also known as: Usual care

Control Group Usual Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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) \[24\].

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Universidade Cidade de São Paulo

São Paulo, São Paulo, 08371-110, Brazil

RECRUITING

Related Publications (32)

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  PMID: 36070134 DERIVED

• Lima CA, Sherrington C, Guaraldo A, Moraes SA, Varanda RD, Melo JA, Kojima KE, Perracini M. Effectiveness of a physical exercise intervention program in improving functional mobility in older adults after hip fracture in later stage rehabilitation: protocol of a randomized clinical trial (REATIVE Study). BMC Geriatr. 2016 Nov 29;16(1):198. doi: 10.1186/s12877-016-0370-7.

  PMID: 27894271 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Monica R Perracini, Phd

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica R Perracini, Phd

CONTACT

+551121781565; monica.perracini@unicid.edu.br

Camila A Lima, Ms

CONTACT

+5511992105950; camilabrown@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at Master's and Doctoral Programs in Physical Therapy

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2019
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

BR (1)