An interventional study of "The Free From Pain Exercise Book" and "The Back Book" in Sarcopenia, Back Pain and Arthritis, sponsored by Talita Cumi Ltd.. Status unknown at 1 site in United Kingdom. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Talita Cumi Ltd. · Not applicable, Interventional, and Treatment
This pragmatic randomised control feasibility trial aims to investigate the effectiveness of the "Free From Pain Exercise Book" in comparison to "The Back Book" for reducing back pain in adults aged 60 and over. The "Free From Pain Exercise Book" contains a 12-week exercise and education programme. The programme is designed to reduce early osteoarthritic and generalised musculoskeletal pain and fear of falling in people over the age of 60. The study will compare the effects of the Free from Pain programme when engaged in independently versus the provision of "The Back Book", which is a booklet that promotes physical activity and a reduction of sedentary behaviour for the purpose of reducing back pain.
Chronic musculoskeletal conditions are the leading cause of disability worldwide. The World Health Organization estimates that approximately 1.71 billion people have musculoskeletal conditions globally. They cause a significant economic burden on the NHS, with £5 billion of England's yearly NHS budget going towards the treatment of musculoskeletal conditions. The most reported musculoskeletal ailment throughout the world is back pain, for which the lifetime prevalence has been reported to be as high as 84%. Back pain can affect individuals of all ages, but has a particularly negative effect on elderly people, causing difficulty in daily living tasks for those over 65 years old. Difficulty in completing everyday tasks can result in immobility, causing a loss of muscle mass and fitness, an increased risk of falls, further injury, and diseases associated with inactivity or sedentary behaviours (such as heart attack and some cancers).
"The Back Book" is a booklet that promotes physical activity and a reduction of sedentary behaviour for the purpose of reducing back pain. One study by Hass et, al. found that the addition of this book to standard treatment improved disability scores significantly. The use of "The Back Book" was further supported by a cluster, randomised control trial which focussed on elderly adults from nursing homes. The study found a significant improvement in disability after one month of being provided with the book. It is known that, in later life, exercise can have many physiological and psychological benefits and can improve functional ability and well-being whilst reducing illness.
The complete "Free From Pain Exercise Book" presents exercises and educational information to improve pain, strength and quality of life in seniors. The "Free from Pain" exercise programme described within the exercise book is a 12-week exercise programme. It is fusion of three different generally accepted exercise programmes. Therapeutic exercise programmes exist for individual body parts, but there is no single generalised exercise programme that targets all body parts. Hence, the creation of this fusion of programmes. The three programmes are the Otago exercises for lower body strength and balance, the motor control exercises for the lower back and the isometric exercises for the neck and shoulder.
The Otago exercise program (OEP) was developed by Robertson and Campbell for the New Zealand accident compensation corporation (ACC). The initial aim of the programme was to improve balance and strength in patients to prevent falls. Further research has shown that the Otago exercise programme is an effective intervention for coping with musculoskeletal pain in community-dwelling older adults. For treating and preventing low back pain, exercise regimes include stretching, strengthening, endurance, aerobic fitness, walking, yoga, Pilates, and motor control exercises. Among these different modalities of exercises for the rehabilitation of low back pain, motor control exercises are one of the most commonly used interventions that have proven to be beneficial. With regards to neck pain, exercise regimes vary from stretching to strengthening exercises. Among the varied regimes, isometric and strengthening exercises of the neck and shoulder are effective modalities for treating neck pain.
Alongside descriptions and images of the exercises described previously, the exercise book also contains 13 chapters. The first chapter acts as an introduction and each of the remaining 12 chapters provide a 'reason to exercise' and an 'exercise-related metaphor'. Each chapter is assigned to a week, from week 1 through to week 12. The reader is encouraged to read one chapter each week over the 12 weeks in the order that they appear in the book.
This pragmatic randomised control feasibility trial will be conducted over 6 months.
60 participants will be split into two even groups of 30 (Group 1 and Group 2). Group 1 (experimental group) will test the use of the "Free From Pain Exercise Book" for reducing back pain and improving quality of life, whilst Group 2 (control group) will test the use of "The Back Book". Each participant will be in the study for a period of six months. As the "Free From Pain" programme is a 12-week exercise programme, the first 12 weeks of the entire six-month study is defined as the intervention period. The subsequent follow-up period, which will run from the 12-week point until the six-month point, is included in the study to allow analysis of long-term participant compliance and to assess the extended effects of both the "Free From Pain Exercise Book" and "The Back Book". Participants will be asked to provide data in the form of completed surveys three times; at baseline, at 12 weeks (once the intervention period is complete) and at six months (at the end of the follow-up period). The study aims to investigate the effectiveness of the "Free From Pain Exercise Book" in comparison to "The Back Book" for reducing back pain in adults aged 60 and over. It will compare the effects of the Free from Pain programme when engaged in independently versus the provision of "The Back Book" - a booklet that promotes physical activity and a reduction of sedentary behaviour for the purpose of reducing back pain.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Talita Cumi Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Participants who consent and are randomised into Group 1 (experimental group) will be provided with the "Free From Pain Exercise Book". Participants in Group 1 will be asked to independently engage in the exercises included in the book throughout the entire 6 month study period. They will be advised to either do all 3 sets of exercises 3 times a week or to do the neck and low back exercises twice a week and the Otago exercises 3 times a week. The exercises should take around an hour to complete each day. Furthermore, it will be recommended that participants in this group read one information chapter and one metaphor each week for 12 weeks, to ensure that they absorb the information fully and do not overbear themselves with information.
Behavioral: "The Free From Pain Exercise Book"
Participants who consent and are randomised into Group 2 (control group) will be provided with "The Back Book". Participants in Group 2 will be asked to ensure that they read the book in its entirety during the 12-week intervention period and refer to relevant sections during the follow-up period for advice if required.
Behavioral: "The Back Book"
Contains educational information and exercises to improve musculoskeletal pain and reduce sarcopenia.
Contains advice and guidance on how to deal with and reduce back pain.
Oswestry Low Back Pain Disability Questionnaire (OLBPDQ)
Differences in Oswestry Low Back Pain Disability Questionnaire (OLBPDQ) scores to will be assessed to quantify changes in back pain. The OLBPDQ comprises ten questions to assess the severity of back pain, and its effects on personal care, carrying out activities (walking, lifting etc.), sleep quality, social life, travelling and sex-life. Levels of pain/effects of pain will be reported by selecting one statement from five, with the most positive statement denoting a score of 0 and the most negative statement denoting a score of 5.
Time frame: Baseline, 12 weeks and 6 months
Numerical Pain Rating Scale (NRPS)
Differences in 11-point Numerical Pain Rating Scale (NPRS) scores to determine changes in back pain. Participants will be required to rate their back pain on this scale, where 0 denotes 'no pain at all' and 10 denotes the 'worst possible pain'.
Time frame: Baseline, 12 weeks and 6 months
EuroQol 5-Dimension (EQ-5D)
Differences in EuroQol 5-Dimension (EQ-5D) Questionnaire scores to observe alterations in health-related quality of life
Time frame: Baseline, 12 weeks and 6 months
Usefulness scale for patient educational material (USE)
Usefulness scale for patient educational material (USE) to evaluate the usefulness of the reading material provided ("Free From Pain Exercise Book" / "The Back Book"). A maximum total score of 90 suggests that the participant 'completely agrees' with nine positive statements regarding the usefullness of the information material provided, whilst a minimum score of 0 suggests that they 'completely disagree' with said statements.
Time frame: 12 weeks and 6 months
Qualatitive questions
Qualitative questions to assess participant opinions regarding the "Free From Pain Exercise Book" and "The Back Book". Questions will include 'What did you like about the "Free From Pain Exercise Book" / "The Back Book?"' and 'How do you think the "Free From Pain Exercise Book" / "The Back Book" could be improved?'.
Time frame: 12 weeks and 6 months
Compliance to participate in the "Free From Pain" exercises
Participants in Group 1 will be required to fill in the exercise diary found at the back of the "Free From Pain Exercise Book" each time they engage in the "Free From Pain" exercises during the initial 12-week intervention period. To assess long-term compliance, they will be required to populate this second diary every time they engage in the "Free From Pain" exercises during the follow-up period.
Time frame: 12 weeks and 6 months
Engagement in exercises following use of "The Back Book"
During a phone call at 12 weeks and six months, participants in Group 2 will be asked to report how much they exercised (if at all) during the intervention and follow-up periods respectively, and what this physical activity involved.
Time frame: 12 weeks and 6 months
Plan to share: Yes — At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Talita Cumi Ltd.