Promoting Physical Activity in the Over 65s

Falls Clinical Trial

— ProAct65+  

Official title:

Multi-centre Cluster Randomised Trial Comparing a Community Group Exercise Programme With Home Based Exercise With Usual Care for Over 65s in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00726531
• Other study ID #: ProAct65+
• Secondary ID: UK HTA grant 06/
• Status: Recruiting
• Phase: Phase 3
• First received: July 29, 2008
• Last updated: July 7, 2010
• Start date: June 2008
• Est. completion date: May 2013

Study information

• Verified date: July 2010
• Source: University College, London
• Contact: Steve Iliffe, MB BS, BSc
• Phone: 00442078302393
• Email: s.iliffe[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the project is to evaluate the delivery, impact and cost effectiveness of a community based exercise programme (FaME); compared to a home based exercise programme (OEP) supported by similarly aged mentors; compared with usual care for primary care patients.

Primary Objective:

1. To determine the effect on continuation of exercise of two evidence based exercise programmes designed for older people, compared with usual care i.e. with no special interventions to promote physical activity.

Secondary Objective:

2. To determine the health benefits of the programmes to patients starting at various levels of physical activity, particularly the effects on physical and psychological status, health status and quality adjusted life years (QALYs).

3. To estimate the costs of the exercise interventions and to assess the cost-effectiveness of community group exercise, and home-supported exercise compared with usual care.

4. To determine the acceptability of the programmes, adherence rates, enabling factors and barriers to future implementation.

5. To determine participants' perceptions of the value of exercise, and the predictors of continued exercise.

Description:

A cluster controlled trial using minimisation for allocation at the level of general practice in two centres (London and Nottingham/Derby), to compare a community-centre based group exercise programme - FaME [delivered by specifically trained postural stability instructors (PSIs) and supplemented by home exercise and prescriptive recommendations for walking], with a home based exercise programme and walking plan - OEP [supported by specifically trained and similarly aged mentors], with two years follow-up to determine the impact, acceptability and adherence to the programme, and longer term continuation of exercise. Control subjects will continue to receive usual care in primary care. A cost-effectiveness analysis will be conducted within the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: May 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Eligible patients will be those aged 65+ who can walk around at home (i.e. not chair or bed bound) and would be physically able to take part in a group exercise class, who are not already receiving any long term physiotherapy and who do not fulfill the exclusion criteria.

Exclusion Criteria:

• Chair or bed bound

• Receiving long-term physiotherapy

• Three or more falls in the previous year i.e. frequent fallers (only excluded if their GP does not consent to them taking part in exercise)

• Resting BP > 180/100 mmHg, tachycardia > 100bpm, uncontrolled hypertension

• Significant drop in BP during exercise

• Psychiatric conditions or physical abilities which would prevent participation in an exercise class (for example psychotic illness, acute systemic illness (e.g. pneumonia), uncontrolled visual or vestibular disturbances which the GP considers would exclude patients from undertaking the exercise programme, poorly controlled angina, acute rheumatoid arthritis, unstable or acute heart failure, or conditions requiring a specialist exercise programme e.g. uncontrolled epilepsy significant neurological disease or impairment, unable to maintain seated upright position or unable to move about independently indoors)

• Not living independently (e.g. residential care)

• Significant cognitive impairment (unable to follow simple instructions)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Falls

Intervention

Behavioral:
• Otago Exercise Programme
Home based exercise programme (OEP) This exercise programme consists of a 30 minute programme of leg muscle strengthening and balance retraining exercises progressing in difficulty to be performed at home at least three times per week, and a walking plan to be undertaken at least two times per week for 24 weeks. . Trained peer mentors will contact and visit the patients at their home to start the exercise programme with them and will follow-up with up to three more home visits / exercise sessions as the participants require
• Fame
Community based exercise programme (FaME) FaME includes and extends the OEP. It will comprise one hour PSI delivered group exercise class in a local community centre for a maximum of 15 participants, and two 30 minute home exercise sessions (based on the extended OEP) per week for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 minutes at a moderate pace.

Other:
• Treatment As Usual
Treatment as usual by the general practitioner

Locations

Country	Name	City	State
United Kingdom	University College London	London
United Kingdom	University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type, intensity, duration and frequency of physical activity		two years after intervention	No