Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Prevention Harmful Effects
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

Description

This project is a cluster-randomized study comparing different implementation strategies. The study will comprise clinical settings in primary health care (PHC) and in senior residential care. Participating clinics will be recruited strategically with regard to catchment area and population structur...

This project is a cluster-randomized study comparing different implementation strategies. The study will comprise clinical settings in primary health care (PHC) and in senior residential care. Participating clinics will be recruited strategically with regard to catchment area and population structure, to achieve such a large diverse participation as possible. Participant to the balance training will be recruited through the participating clinics, from primary care facilities in the vicinity of the clinics involved and by advertisement in local papers in the communities. Participants reporting their interest to partake in the study will be telephone-interview and informed about the project and checked for eligibility. Thereafter, they will be called to baseline testing. The investigators plan to involve 30 different PHC and thereby 360-480 participants in balance training (two groups with 6-8 participants per semester from each clinic during 2 semesters). In two previous randomised controlled studies performed by the research group in Stockholm county regarding group balance-training for older adults at risk of falling the investigators received a large number of people reporting interest by announcement, i.e. approximately 500 subjects. However, most of them were excluded because they had not a verified diagnosis of osteoporosis, which was one of the inclusion criteria's in those two studies. The group based balance-training program is well described in a published ´Rehabilitation in practice´- article and was developed based on well-established principles of exercise and on the knowledge that balance control relies on the interaction of several physiological systems, as well as interaction with environmental factors and the performed task. It includes exercise with dual- and multi task performance, i.e. performance when a person's attention is divided between a motor and a cognitive task, as this is a natural component of daily activities, but may increase the risk of falling especially in older adults. As training adaptions are specific for the system trained, this program follows the principle of specificity in that it is based on exercises targeting various systems for postural control aiming to improve balance performance in specific situations that can occur in daily life, such as regaining postural stability after perturbation or being able to suddenly avoid an obstacle, with retained balance, while simultaneously walking and answering a question. Furthermore, it is progressive as the exercises can be performed at different levels (basic, moderate, and advanced), making it progressively challenging for each individual throughout the whole program. The training is conducted as an individually tailored group program. The 12-week balance training program will be performed two times per week for one hour each. The training will be lead by physiotherapists or trained leaders. After the balance training the participants will get recommendations for continued physical activity and training, i.e. "Physical activity on prescription". For the implementation a participatory approach will be used, where the different settings will be engaged in an early phase. For evaluation the model by Proctor et al., will be followed. The implementation strategies will include 1) a contract with each setting, 2) meetings with the head of each setting, 3) discussion with physical therapists and leaders in the setting, 4) education of the physical therapists and leaders who will be trainers and 5) coaching of the trainers. Implementation outcomes will include: Acceptability of evidence-based treatments among health providers will be assessed by investigating the attitudes towards the balance program with a questionnaire, focus groups and interviews. Feasibility the extent to which a new treatment can be successfully used and carried out in the clinical setting will be assessed by investigating how the balance program fits in in clinical practice with focus groups and interviews. Fidelity includes five dimensions, i.e. adherence to the program protocol, quality of delivery, program component differentiation, exposure to the intervention and participant responsiveness to the program will be investigated by observations, check-lists and assessments on individual level (see below). Cost will be assessed by a health economic evaluation of the program. Sustainability will be assessed using both quantitative and qualitative methods and include measures on compliance/fidelity to the training program. Assessments on individual level will include fall-related concerns, health related quality of life, balance performance, gait, physical activity, muscle strength for lower extremities and number of falls and compliance to training. The assessments on individual level will be performed at the PHC by the regular physiotherapist. All participants will be assessed before and after the training period (3 months after inclusion) and at three to six, twelve eight-teen and twenty-four months, i.e. two years after inclusion. During the follow-up period, i.e. three, six, twelve, eight-teen and twenty-four months, the assessments will consists of sms-track system and by postal survey with questionnaire regarding fall-related concerns, heath related quality of life, physical activity and adherence to training regime.

Tracking Information

NCT #
NCT02909374
Collaborators
Not Provided
Investigators
Principal Investigator: Alexandra Halvarsson, med.dr Karolinska Institutet