Can physical activity enhance emotion, memory, attention and concentration in breast cancer patients receiving chemotherapy?
| ISRCTN | ISRCTN50709297 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50709297 |
| Protocol serial number | 11/EM/0437 |
| Sponsor | Loughborough University (UK) |
| Funder | School of Sport, Exercise and Health Science at Loughborough University (UK) |
- Submission date
- 23/10/2012
- Registration date
- 31/10/2012
- Last edited
- 23/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Miss Kajal Gokal
Scientific
Scientific
School of Sport, Exercise and Health Sciences
Loughbrough University
L1.16 Wavy Top Building
Loughborough
LE11 3TU
United Kingdom
| Phone | +44 (0)1509 228 152 |
|---|---|
| k.gokal@lboro.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Physical activity intervention for emotional & cognitive functioning in breast cancer patients receiving chemotherapy |
| Study objectives | 1. Women who complete the physical activity intervention will report higher emotional well-being and show less impairment on memory, attention and concentration tasks in comparison to women in the non-intervention group. 2. Within the intervention group, emotional well-being will mediate between physical activity level and level of impairment in memory, attention and concentration. |
| Ethics approval(s) | NRES committee East Midlands - Northampton, 02/02/2012, ref: 11/EM/0437 |
| Health condition(s) or problem(s) studied | Breast cancer patients |
| Intervention | The study will involve 26 breast cancer patients committing to a 12-week home-based, moderate intensity walking intervention. Patients in this group will be provided with guidance, encouragement and motivation to incorporate 30 mins of moderate intensity walking five times a week around their treatment schedules. The control comparison will receive usual care only. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Measures of emotional distress and cognitive functioning. |
| Key secondary outcome measure(s) |
Self-esteem, fatigue, intention to exercise, executive function, memory, attention, visual-spatial skills and motor function. |
| Completion date | 01/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Target sample size at registration | 52 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Age 18-75 female breast cancer patients 2. Those who do not exceed recommended guidelines of 30 mins of moderate intensity exercise five times a week. 3. Those whose breast cancer is a primary diagnosis 4. Those who have no previous history of cancer 5. Those who are able to speak and read standard English |
| Key exclusion criteria | 1. Males 2. Those who exceed the recommended guidelines of 30 minutes exercise five times a week 3. Those whose breast cancer is a secondary diagnosis 4. Those who have previous history of cancer 5. Those who cannot speak and read Standard English |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/10/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Loughbrough University
Loughborough
LE11 3TU
United Kingdom
LE11 3TU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | psychosocial wellbeing and physical activity results | 01/03/2016 | Yes | No | |
| Results article | cognitive decline results | 28/11/2018 | 23/04/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added from the results publication.
