The Study Will Recruit Adults Aged 60 Years or OlderNCT02663726
Adapted Yoga for Inactive Older Adults
A study testing Yoga and Written advice in people with The Study Will Recruit Adults Aged 60 Years or Older, run by Northumbria University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Study Will Recruit Adults Aged 60 Years or Older
- What is being tested?
- Yoga and Written advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Yorkshire Yoga & Therapy Centre
Knaresborough, North Yorkshire, HG5 0TG
About this study
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
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.
Read the detailed 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.
- Being tested
- Yoga, Written advice
- Keywords
- Physically inactive, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
10 weekly 75-min sessions of specialised yoga
Written adviceBehavioural
Written advice about physical activity
| Study group | Role | What they receive |
|---|---|---|
| Yoga intervention group | Experimental | 10 weekly 75-min sessions of specialised yoga plus written advice about physical activity for older adults Receives: Other: Yoga; Behavioral: Written advice |
| Waiting list control group | Active comparator | Usual care plus written advice about physical activity for older adults Receives: Behavioral: Written advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Performance Physical Battery
Measured: 3 months
Secondary outcomes (4)
EQ-5D-5L
Measured: 3 months
Warwick-Edinburgh Mental Well-being Scale
Measured: 3 months
Back scratch test of upper-body flexibility
Measured: 3 months
Chair sit-and-reach test of lower-body flexibility
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for The Study Will Recruit Adults Aged 60 Years or OlderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Yorkshire Yoga & Therapy Centre, The British Wheel of Yoga, Big Lottery Fund - Awards for All
- Responsible party
- Principal investigator, Garry Tew, Northumbria University
- Investigators
- Garry A Tew, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663726
- Sponsor's protocol ID
- HLSGT180116
- Status last verified
- Sep 2016
- First submitted
- 21 Jan 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22909385Youkhana 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.
PubMed 26707903Tew GA, Howsam J, Hardy M, Bissell L. Adapted yoga to improve physical function and health-related quality of life in physically-inactive older adults: a randomised controlled pilot trial. BMC Geriatr. 2017 Jun 23;17(1):131. doi: 10.1186/s12877-017-0520-6.
PubMed 28645259
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02663726
- Acronym / sponsor ID
- HLSGT180116
- Keywords
- Physically inactive, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Yorkshire Yoga & Therapy Centre, The British Wheel of Yoga, Big Lottery Fund - Awards for All
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga intervention group | Experimental | Other: Yoga, Behavioral: Written advice10 weekly 75-min sessions of specialised yoga plus written advice about physical activity for older adults |
| Waiting list control group | Active comparator | Behavioral: Written adviceUsual care plus written advice about physical activity for older adults |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga10 weekly 75-min sessions of specialised yoga | Other | Yoga intervention group |
| Written adviceWritten advice about physical activity | Behavioural | Waiting list control group, Yoga intervention group |
Primary outcome
Short Performance Physical Battery
Time frame: 3 months
4 secondary outcomes
EQ-5D-5L
Time frame: 3 months
Warwick-Edinburgh Mental Well-being Scale
Time frame: 3 months
Back scratch test of upper-body flexibility
Time frame: 3 months
Chair sit-and-reach test of lower-body flexibility
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Background: PubMed 22909385Patel 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.
- Background: PubMed 26707903Youkhana 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.
- Derived from this study: PubMed 28645259Tew GA, Howsam J, Hardy M, Bissell L. Adapted yoga to improve physical function and health-related quality of life in physically-inactive older adults: a randomised controlled pilot trial. BMC Geriatr. 2017 Jun 23;17(1):131. doi: 10.1186/s12877-017-0520-6.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garry A Tew, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga and Written advice in people with The Study Will Recruit Adults Aged 60 Years or Older, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Performance Physical Battery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663726, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.