Efficacy of a multi-component exercise programme and nutritional supplementation on musculoskeletal health in men treated with androgen deprivation therapy for prostate cancer (IMPACT): study protocol of a randomised controlled trial.
Study Goal
The researchers aimed to determine whether a protein-, calcium-, and vitamin D-enriched supplement combined with exercise could improve bone health in men undergoing androgen deprivation therapy for prostate cancer.
Results Summary
The study assessed the effects of the intervention on bone mineral density and other health measures, but specific results regarding calcium's effects were not detailed in the abstract.
Population
Men currently treated with androgen deprivation therapy for prostate cancer.
Effective Dosage
Not specified
Duration
52 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
a targeted, multi-component resistance and impact-loading exercise programme together with a daily protein-, calcium- and vitamin D-enriched supplement | neutral | bone health | men treated with ADT for prostate cancer | - | examine the efficacy | #1 |
a targeted, multi-component resistance and impact-loading exercise programme together with a daily protein-, calcium- and vitamin D-enriched supplement | neutral | measures of total body and regional body composition | men treated with ADT for prostate cancer | - | determine the effects | #2 |
a targeted, multi-component resistance and impact-loading exercise programme together with a daily protein-, calcium- and vitamin D-enriched supplement | neutral | cardiometabolic risk | men treated with ADT for prostate cancer | - | determine the effects | #3 |
a targeted, multi-component resistance and impact-loading exercise programme together with a daily protein-, calcium- and vitamin D-enriched supplement | neutral | inflammatory markers | men treated with ADT for prostate cancer | - | determine the effects | #4 |
a targeted, multi-component resistance and impact-loading exercise programme together with a daily protein-, calcium- and vitamin D-enriched supplement | neutral | health-related quality of life | men treated with ADT for prostate cancer | - | determine the effects | #5 |
a targeted, multi-component resistance and impact-loading exercise programme together with a daily protein-, calcium- and vitamin D-enriched supplement | neutral | cognitive function | men treated with ADT for prostate cancer | - | determine the effects | #6 |
a multi-component intervention incorporating a targeted bone and muscle-loading programme in combination with a protein-, calcium- and vitamin D-enriched supplement | decrease | multiple adverse effects of ADT | men treated with ADT for prostate cancer | - | can ameliorate | #7 |
BACKGROUND: Prostate cancer is the most commonly diagnosed cancer in men in developed countries. Androgen deprivation therapy (ADT) is a systemic treatment shown to increase survival in selected patients with prostate cancer. The use of ADT continues to increase for all stages and grades of prostate cancer despite known treatment-induced adverse effects. The primary aim of this study is to examine the efficacy of a targeted, multi-component resistance and impact-loading exercise programme together with a daily protein-, calcium- and vitamin D-enriched supplement on bone health in men treated with ADT for prostate cancer. Secondary aims are to determine the effects of this intervention on measures of total body and regional body composition, cardiometabolic risk, inflammatory markers, health-related quality of life and cognitive function. METHODS: This study is a two-arm randomised controlled trial. Men currently treated with ADT for prostate cancer will be randomised to either a 52-week, community-based, exercise training and nutritional supplementation intervention (n = 51) or usual care control (n = 51). Participants will be assessed at baseline, 26 weeks and 52 weeks for all measures. The primary outcome measures are proximal femur and lumbar spine areal bone mineral density (BMD). Secondary outcomes comprise: changes in tibial and radial bone structure and strength, total body and regional body composition, muscle strength and function, as well as cardiometabolic health, catabolic/inflammatory and anabolic/anti-inflammatory cytokines, health-related quality of life and cognitive function. DISCUSSION: This study investigates whether a multi-component intervention incorporating a targeted bone and muscle-loading programme in combination with a protein-, calcium- and vitamin D-enriched supplement can ameliorate multiple adverse effects of ADT when compared to usual care. The results will contribute to the development of exercise training and nutrition guidelines for optimising overall health in men treated with ADT for prostate cancer. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry (ANZCTR), ID: ACTRN12614000317695 . Registered on 25 march 2014.