Adapted Yoga for Inactive Older Adults

The Study Will Recruit Adults Aged 60 Years or Older Clinical Trial

Official title:

A Pilot Randomised Controlled Trial Investigating the Effects of a 10-week Yoga Intervention on Physical Function and Health-related Quality of Life in Physically-inactive Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663726
• Other study ID #: HLSGT180116
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: September 20, 2016
• Start date: February 2016
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

There is evidence that yoga has beneficial effects on several aspects of physical and mental health. However, few studies have explored the acceptability and health effects of yoga in older adults. This preliminary study will explore the effects of a 10-week yoga intervention on physical function and quality of life in older adults. Data collected in this study will be used to inform the design of a subsequent adequately-powered randomised controlled trial.

Description:

Older adults (i.e. aged ≥60 years) who are physically inactive are at increased risk of falls, functional limitations, disability, and mental health problems. Encouragingly, there is evidence that various physical activity interventions can elicit meaningful improvements in physical function and health-related quality of life in older people. Effective programmes have included aerobic exercise, progressive resistance training and Tai Chi. Yoga is an alternative approach to improving fitness and health outcomes in older adults. The benefits of yoga may be greater than those of exercise alone because yoga offers a combination of physical exercise with mental focus, and participants are taught good posture, self-awareness, and self-care along with relaxation. Indeed, a recent systematic review and meta-analysis that included 16 studies (n=649) concluded that yoga may provide greater improvements in physical functioning and self-reported health status than conventional physical activity interventions in elderly people. However, the previous studies had limitations, including small sample sizes, a single yoga teacher delivering the programme, and short-term follow-up. Furthermore, none of the included studies had been conducted in the United Kingdom. Many different schools of hatha yoga exist in the West, such as Iyengar, Sivananda, Viniyoga, Bikram (Hot Yoga), and it is likely that some of these forms are more acceptable and effective than others in elderly people, many of whom present with multiple morbidities. Gentle Years Yoga© is a yoga programme which was developed in North Yorkshire, England by the British Wheel of Yoga 'Approved Centre' Yorkshire Yoga in 2009 to cater specifically for the needs of older people with age-related conditions such as osteoarthritis, arthroplasty, dementia, sensory impairment. To date, only anecdotal evidence exists regarding the acceptability, feasibility and effectiveness of this programme; therefore, further research is warranted. Here, we are proposing to conduct a two-arm, parallel-group, pilot randomised controlled trial in physically inactive adults aged ≥60 years, the aims of which are to: (i) inform the design of, and assess the feasibility of conducting, a definitive randomised controlled trial, and; (ii) explore the acceptability, safety and potential benefits of the Gentle Years Yoga© programme in this specific population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

Age =60 years Able to provide written informed consent and complete the study questionnaires Able to travel to a study centre for assessment visits and yoga sessions

Exclusion Criteria:

Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine Planned major surgery within 3 months of the proposed baseline assessment date Current participation in >90 min/week of purposeful exercise, such as jogging or swimming Participation in another clinical trial for with concurrent participation is deemed inappropriate

Study Design

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

Related Conditions & MeSH terms

• The Study Will Recruit Adults Aged 60 Years or Older

Intervention

Other:
• Yoga
10 weekly 75-min sessions of specialised yoga

Behavioral:
• Written advice
Written advice about physical activity

Locations

Country	Name	City	State
United Kingdom	Yorkshire Yoga & Therapy Centre	Knaresborough	North Yorkshire

Sponsors (4)

Lead Sponsor	Collaborator
Northumbria University	Big Lottery Fund - Awards for All, The British Wheel of Yoga, Yorkshire Yoga & Therapy Centre

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Patel NK, Newstead AH, Ferrer RL. The effects of yoga on physical functioning and health related quality of life in older adults: a systematic review and meta-analysis. J Altern Complement Med. 2012 Oct;18(10):902-17. doi: 10.1089/acm.2011.0473. Epub 2012 Aug 21. Review. — View Citation

Youkhana S, Dean CM, Wolff M, Sherrington C, Tiedemann A. Yoga-based exercise improves balance and mobility in people aged 60 and over: a systematic review and meta-analysis. Age Ageing. 2016 Jan;45(1):21-9. doi: 10.1093/ageing/afv175. Epub 2015 Dec 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Performance Physical Battery		3 months	No
Secondary	EQ-5D-5L		3 months	No
Secondary	Warwick-Edinburgh Mental Well-being Scale		3 months	No
Secondary	Back scratch test of upper-body flexibility		3 months	No
Secondary	Chair sit-and-reach test of lower-body flexibility		3 months	No